Trial Outcomes & Findings for Halifax PrenaBelt Trial (NCT NCT02377817)
NCT ID: NCT02377817
Last Updated: 2020-04-02
Results Overview
Proportion of sleeping time spent in the supine position
COMPLETED
NA
23 participants
1 night (approximately 8 hours)
2020-04-02
Participant Flow
Participants were recruited from April 4 2016 through January 27 2017. Participants were recruited by a trained nurse a prenatal clinic at the Izaak Walton Killam (IWK) Health Centre, Halifax, Canada, which is a tertiary and primary care center for women and children.
There was no run-in measurement of baseline sleep habits. The study nights were not required to be consecutive dates. We did not specify a defined washout period. 28 participants were assessed for eligibility. Following exclusion of three who declined participation and two who failed to meet eligibility criteria, 23 were randomized.
Participant milestones
| Measure |
PrenaBelt on First Night, Sham PrenaBelt on Second Night
These participants were randomized to receive the PrenaBelt on first night, and the sham-PrenaBelt on second night.
PrenaBelt: The PrenaBelt is a belt-like, positional therapy (PT) device designed specifically for pregnant women. While the PrenaBelt does not prevent the user from lying on her back or right side during sleep, it is expected to significantly decrease the amount of time she spends in these two positions via the mechanism of PT.
The PrenaBelt is worn at the level of the waist. By virtue of its design and position on the user's body, the PrenaBelt affects subtle pressure points on the back of the user when she lies on her back, activating her body's natural mechanism to spontaneously reposition itself to relieve discomfort, thereby reducing the amount of time she remains on her back.
Sham PrenaBelt: The Sham PrenaBelt and PrenaBelt are the same device except the plastic balls are removed from the Sham PrenaBelt so it cannot provide pressure points.
|
Sham PrenaBelt on First Night, PrenaBelt on Second Night
These participants were randomized to receive the sham-PrenaBelt on first night, and the PrenaBelt on second night.
PrenaBelt: The PrenaBelt is a belt-like, positional therapy (PT) device designed specifically for pregnant women. While the PrenaBelt does not prevent the user from lying on her back or right side during sleep, it is expected to significantly decrease the amount of time she spends in these two positions via the mechanism of PT.
The PrenaBelt is worn at the level of the waist. By virtue of its design and position on the user's body, the PrenaBelt affects subtle pressure points on the back of the user when she lies on her back, activating her body's natural mechanism to spontaneously reposition itself to relieve discomfort, thereby reducing the amount of time she remains on her back.
Sham PrenaBelt: The Sham PrenaBelt and PrenaBelt are the same device except the plastic balls are removed from the Sham PrenaBelt so it cannot provide pressure points.
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
Reasons for withdrawal
| Measure |
PrenaBelt on First Night, Sham PrenaBelt on Second Night
These participants were randomized to receive the PrenaBelt on first night, and the sham-PrenaBelt on second night.
PrenaBelt: The PrenaBelt is a belt-like, positional therapy (PT) device designed specifically for pregnant women. While the PrenaBelt does not prevent the user from lying on her back or right side during sleep, it is expected to significantly decrease the amount of time she spends in these two positions via the mechanism of PT.
The PrenaBelt is worn at the level of the waist. By virtue of its design and position on the user's body, the PrenaBelt affects subtle pressure points on the back of the user when she lies on her back, activating her body's natural mechanism to spontaneously reposition itself to relieve discomfort, thereby reducing the amount of time she remains on her back.
Sham PrenaBelt: The Sham PrenaBelt and PrenaBelt are the same device except the plastic balls are removed from the Sham PrenaBelt so it cannot provide pressure points.
|
Sham PrenaBelt on First Night, PrenaBelt on Second Night
These participants were randomized to receive the sham-PrenaBelt on first night, and the PrenaBelt on second night.
PrenaBelt: The PrenaBelt is a belt-like, positional therapy (PT) device designed specifically for pregnant women. While the PrenaBelt does not prevent the user from lying on her back or right side during sleep, it is expected to significantly decrease the amount of time she spends in these two positions via the mechanism of PT.
The PrenaBelt is worn at the level of the waist. By virtue of its design and position on the user's body, the PrenaBelt affects subtle pressure points on the back of the user when she lies on her back, activating her body's natural mechanism to spontaneously reposition itself to relieve discomfort, thereby reducing the amount of time she remains on her back.
Sham PrenaBelt: The Sham PrenaBelt and PrenaBelt are the same device except the plastic balls are removed from the Sham PrenaBelt so it cannot provide pressure points.
|
|---|---|---|
|
Overall Study
Transportation/childcare barriers.
|
2
|
0
|
|
Overall Study
Unrelated injury prevented lateral sleep
|
1
|
0
|
Baseline Characteristics
Halifax PrenaBelt Trial
Baseline characteristics by cohort
| Measure |
PrenaBelt on First Night, Sham PrenaBelt on Second Night
n=10 Participants
These participants were randomized to receive the PrenaBelt on first night, and the sham-PrenaBelt on second night.
PrenaBelt: The PrenaBelt is a belt-like, positional therapy (PT) device designed specifically for pregnant women. While the PrenaBelt does not prevent the user from lying on her back or right side during sleep, it is expected to significantly decrease the amount of time she spends in these two positions via the mechanism of PT.
The PrenaBelt is worn at the level of the waist. By virtue of its design and position on the user's body, the PrenaBelt affects subtle pressure points on the back of the user when she lies on her back, activating her body's natural mechanism to spontaneously reposition itself to relieve discomfort, thereby reducing the amount of time she remains on her back.
Sham PrenaBelt: The Sham PrenaBelt and PrenaBelt are the same device except the plastic balls are removed from the Sham PrenaBelt so it cannot provide pressure points.
|
Sham PrenaBelt on First Night, PrenaBelt on Second Night
n=10 Participants
These participants were randomized to receive the sham-PrenaBelt on first night, and the PrenaBelt on second night.
PrenaBelt: The PrenaBelt is a belt-like, positional therapy (PT) device designed specifically for pregnant women. While the PrenaBelt does not prevent the user from lying on her back or right side during sleep, it is expected to significantly decrease the amount of time she spends in these two positions via the mechanism of PT.
The PrenaBelt is worn at the level of the waist. By virtue of its design and position on the user's body, the PrenaBelt affects subtle pressure points on the back of the user when she lies on her back, activating her body's natural mechanism to spontaneously reposition itself to relieve discomfort, thereby reducing the amount of time she remains on her back.
Sham PrenaBelt: The Sham PrenaBelt and PrenaBelt are the same device except the plastic balls are removed from the Sham PrenaBelt so it cannot provide pressure points.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
31.1 years
STANDARD_DEVIATION 6.0 • n=99 Participants
|
30.7 years
STANDARD_DEVIATION 4.1 • n=107 Participants
|
30.9 years
STANDARD_DEVIATION 5.0 • n=206 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
6 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Filipino
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Middle Eastern
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Indian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
Canada
|
10 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Pre-pregnancy BMI
|
27.0 kg/m^2
STANDARD_DEVIATION 3.3 • n=99 Participants
|
26.2 kg/m^2
STANDARD_DEVIATION 3.5 • n=107 Participants
|
26.6 kg/m^2
STANDARD_DEVIATION 3.3 • n=206 Participants
|
|
Current BMI
|
30.9 kg/m^2
STANDARD_DEVIATION 3.7 • n=99 Participants
|
29.9 kg/m^2
STANDARD_DEVIATION 3.6 • n=107 Participants
|
30.4 kg/m^2
STANDARD_DEVIATION 3.6 • n=206 Participants
|
|
Gestational age
|
30.9 weeks
STANDARD_DEVIATION 3.0 • n=99 Participants
|
30.8 weeks
STANDARD_DEVIATION 2.8 • n=107 Participants
|
30.9 weeks
STANDARD_DEVIATION 2.8 • n=206 Participants
|
|
Gravidity
Gravida 1
|
4 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Gravidity
Gravida ≥2
|
6 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Nightly sleep duration
|
8.0 hours
n=99 Participants
|
7.8 hours
n=107 Participants
|
8.0 hours
n=206 Participants
|
|
In the last week, sleep onset position
Left
|
7 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
In the last week, sleep onset position
Supine
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
In the last week, sleep onset position
Right
|
8 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
In the last week, sleep onset position
Prone
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
In the last week, waking position
Left
|
8 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
In the last week, waking position
Supine
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
In the last week, waking position
Right
|
5 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
In the last week, waking position
Prone
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
When not pregnant, sleep onset position
Left
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
When not pregnant, sleep onset position
Supine
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
When not pregnant, sleep onset position
Right
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
When not pregnant, sleep onset position
Prone
|
7 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
When not pregnant, waking position
Left
|
5 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
When not pregnant, waking position
Supine
|
4 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
When not pregnant, waking position
Right
|
5 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
When not pregnant, waking position
Prone
|
5 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Snores ≥3 nights per week
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Sleeps with bed partner
|
7 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Pillow use
Under head
|
9 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Pillow use
Between knees
|
8 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Pillow use
Behind back
|
3 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Pillow use
Under tummy
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Pillow use
Pregnancy pillow
|
4 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 1 night (approximately 8 hours)Population: Twenty (n=20) participants completed the study. Each of these participants spent two nights in the sleep lab - one night wearing the PrenaBelt and one night wearing the sham PrenaBelt. This constitutes 40 nights (20 nights with the PrenaBelt and 20 nights with the sham PrenaBelt).
Proportion of sleeping time spent in the supine position
Outcome measures
| Measure |
PrenaBelt Night
n=20 Participants
On this night, the participants wore the PrenaBelt.
PrenaBelt: The PrenaBelt is a belt-like, positional therapy (PT) device designed specifically for pregnant women. While the PrenaBelt does not prevent the user from lying on her back or right side during sleep, it is expected to significantly decrease the amount of time she spends in these two positions via the mechanism of PT.
The PrenaBelt is worn at the level of the waist. By virtue of its design and position on the user's body, the PrenaBelt affects subtle pressure points on the back of the user when she lies on her back, activating her body's natural mechanism to spontaneously reposition itself to relieve discomfort, thereby reducing the amount of time she remains on her back.
|
Sham PrenaBelt Night
n=20 Participants
On this night, the participants wore the sham PrenaBelt.
Sham PrenaBelt: The Sham PrenaBelt and PrenaBelt are the same device except the plastic balls are removed from the Sham PrenaBelt so it cannot provide pressure points.
|
|---|---|---|
|
Percentage (%) of Sleep Time Supine
|
3.5 percentage of sleep time (%)
Interval 0.0 to 16.6
|
16.4 percentage of sleep time (%)
Interval 3.5 to 25.3
|
SECONDARY outcome
Timeframe: 1 night (approximately 8 hours)Population: Twenty (n=20) participants completed the study. Each of these participants spent two nights in the sleep lab - one night wearing the PrenaBelt and one night wearing the sham PrenaBelt. This constitutes 40 nights (20 nights with the PrenaBelt and 20 nights with the sham PrenaBelt).
This is a standard polysomnography measure of the amount of time the participant spent sleeping during the sleep test.
Outcome measures
| Measure |
PrenaBelt Night
n=20 Participants
On this night, the participants wore the PrenaBelt.
PrenaBelt: The PrenaBelt is a belt-like, positional therapy (PT) device designed specifically for pregnant women. While the PrenaBelt does not prevent the user from lying on her back or right side during sleep, it is expected to significantly decrease the amount of time she spends in these two positions via the mechanism of PT.
The PrenaBelt is worn at the level of the waist. By virtue of its design and position on the user's body, the PrenaBelt affects subtle pressure points on the back of the user when she lies on her back, activating her body's natural mechanism to spontaneously reposition itself to relieve discomfort, thereby reducing the amount of time she remains on her back.
|
Sham PrenaBelt Night
n=20 Participants
On this night, the participants wore the sham PrenaBelt.
Sham PrenaBelt: The Sham PrenaBelt and PrenaBelt are the same device except the plastic balls are removed from the Sham PrenaBelt so it cannot provide pressure points.
|
|---|---|---|
|
Total Sleep Time
|
353 minutes
Interval 318.0 to 376.0
|
350 minutes
Interval 318.0 to 374.0
|
SECONDARY outcome
Timeframe: 1 night (approximately 8 hours)Population: Twenty (n=20) participants completed the study. Each of these participants spent two nights in the sleep lab - one night wearing the PrenaBelt and one night wearing the sham PrenaBelt. This constitutes 40 nights (20 nights with the PrenaBelt and 20 nights with the sham PrenaBelt).
The time (in minutes) spent sleeping in the supine position.
Outcome measures
| Measure |
PrenaBelt Night
n=20 Participants
On this night, the participants wore the PrenaBelt.
PrenaBelt: The PrenaBelt is a belt-like, positional therapy (PT) device designed specifically for pregnant women. While the PrenaBelt does not prevent the user from lying on her back or right side during sleep, it is expected to significantly decrease the amount of time she spends in these two positions via the mechanism of PT.
The PrenaBelt is worn at the level of the waist. By virtue of its design and position on the user's body, the PrenaBelt affects subtle pressure points on the back of the user when she lies on her back, activating her body's natural mechanism to spontaneously reposition itself to relieve discomfort, thereby reducing the amount of time she remains on her back.
|
Sham PrenaBelt Night
n=20 Participants
On this night, the participants wore the sham PrenaBelt.
Sham PrenaBelt: The Sham PrenaBelt and PrenaBelt are the same device except the plastic balls are removed from the Sham PrenaBelt so it cannot provide pressure points.
|
|---|---|---|
|
Supine Sleep Time
|
12.3 minutes
Interval 0.0 to 53.5
|
56.8 minutes
Interval 12.4 to 79.1
|
SECONDARY outcome
Timeframe: 1 night (approximately 8 hours)Population: Twenty (n=20) participants completed the study. Each of these participants spent two nights in the sleep lab - one night wearing the PrenaBelt and one night wearing the sham PrenaBelt. This constitutes 40 nights (20 nights with the PrenaBelt and 20 nights with the sham PrenaBelt).
Time (in minutes) spent sleeping in the left-lateral position.
Outcome measures
| Measure |
PrenaBelt Night
n=20 Participants
On this night, the participants wore the PrenaBelt.
PrenaBelt: The PrenaBelt is a belt-like, positional therapy (PT) device designed specifically for pregnant women. While the PrenaBelt does not prevent the user from lying on her back or right side during sleep, it is expected to significantly decrease the amount of time she spends in these two positions via the mechanism of PT.
The PrenaBelt is worn at the level of the waist. By virtue of its design and position on the user's body, the PrenaBelt affects subtle pressure points on the back of the user when she lies on her back, activating her body's natural mechanism to spontaneously reposition itself to relieve discomfort, thereby reducing the amount of time she remains on her back.
|
Sham PrenaBelt Night
n=20 Participants
On this night, the participants wore the sham PrenaBelt.
Sham PrenaBelt: The Sham PrenaBelt and PrenaBelt are the same device except the plastic balls are removed from the Sham PrenaBelt so it cannot provide pressure points.
|
|---|---|---|
|
Left-lateral Sleep Time
|
185.6 minutes
Standard Deviation 102.5
|
176.1 minutes
Standard Deviation 95.2
|
SECONDARY outcome
Timeframe: 1 night (approximately 8 hours)Population: Twenty (n=20) participants completed the study. Each of these participants spent two nights in the sleep lab - one night wearing the PrenaBelt and one night wearing the sham PrenaBelt. This constitutes 40 nights (20 nights with the PrenaBelt and 20 nights with the sham PrenaBelt).
Time (in minutes) spent sleeping in the right-lateral position.
Outcome measures
| Measure |
PrenaBelt Night
n=20 Participants
On this night, the participants wore the PrenaBelt.
PrenaBelt: The PrenaBelt is a belt-like, positional therapy (PT) device designed specifically for pregnant women. While the PrenaBelt does not prevent the user from lying on her back or right side during sleep, it is expected to significantly decrease the amount of time she spends in these two positions via the mechanism of PT.
The PrenaBelt is worn at the level of the waist. By virtue of its design and position on the user's body, the PrenaBelt affects subtle pressure points on the back of the user when she lies on her back, activating her body's natural mechanism to spontaneously reposition itself to relieve discomfort, thereby reducing the amount of time she remains on her back.
|
Sham PrenaBelt Night
n=20 Participants
On this night, the participants wore the sham PrenaBelt.
Sham PrenaBelt: The Sham PrenaBelt and PrenaBelt are the same device except the plastic balls are removed from the Sham PrenaBelt so it cannot provide pressure points.
|
|---|---|---|
|
Right-lateral Sleep Time
|
108.9 minutes
Standard Deviation 110.1
|
101.9 minutes
Standard Deviation 100.9
|
SECONDARY outcome
Timeframe: 1 night (approximately 8 hours)Population: Twenty (n=20) participants completed the study. Each of these participants spent two nights in the sleep lab - one night wearing the PrenaBelt and one night wearing the sham PrenaBelt. This constitutes 40 nights (20 nights with the PrenaBelt and 20 nights with the sham PrenaBelt).
Percentage (%) of sleeping time in the left-lateral position.
Outcome measures
| Measure |
PrenaBelt Night
n=20 Participants
On this night, the participants wore the PrenaBelt.
PrenaBelt: The PrenaBelt is a belt-like, positional therapy (PT) device designed specifically for pregnant women. While the PrenaBelt does not prevent the user from lying on her back or right side during sleep, it is expected to significantly decrease the amount of time she spends in these two positions via the mechanism of PT.
The PrenaBelt is worn at the level of the waist. By virtue of its design and position on the user's body, the PrenaBelt affects subtle pressure points on the back of the user when she lies on her back, activating her body's natural mechanism to spontaneously reposition itself to relieve discomfort, thereby reducing the amount of time she remains on her back.
|
Sham PrenaBelt Night
n=20 Participants
On this night, the participants wore the sham PrenaBelt.
Sham PrenaBelt: The Sham PrenaBelt and PrenaBelt are the same device except the plastic balls are removed from the Sham PrenaBelt so it cannot provide pressure points.
|
|---|---|---|
|
Percentage Sleep Left
|
57.0 percentage of sleep time (%)
Standard Deviation 26.9
|
52.2 percentage of sleep time (%)
Standard Deviation 27.0
|
SECONDARY outcome
Timeframe: 1 night (approximately 8 hours)Population: Twenty (n=20) participants completed the study. Each of these participants spent two nights in the sleep lab - one night wearing the PrenaBelt and one night wearing the sham PrenaBelt. This constitutes 40 nights (20 nights with the PrenaBelt and 20 nights with the sham PrenaBelt).
Percentage (%) of sleeping time in the right-lateral position.
Outcome measures
| Measure |
PrenaBelt Night
n=20 Participants
On this night, the participants wore the PrenaBelt.
PrenaBelt: The PrenaBelt is a belt-like, positional therapy (PT) device designed specifically for pregnant women. While the PrenaBelt does not prevent the user from lying on her back or right side during sleep, it is expected to significantly decrease the amount of time she spends in these two positions via the mechanism of PT.
The PrenaBelt is worn at the level of the waist. By virtue of its design and position on the user's body, the PrenaBelt affects subtle pressure points on the back of the user when she lies on her back, activating her body's natural mechanism to spontaneously reposition itself to relieve discomfort, thereby reducing the amount of time she remains on her back.
|
Sham PrenaBelt Night
n=20 Participants
On this night, the participants wore the sham PrenaBelt.
Sham PrenaBelt: The Sham PrenaBelt and PrenaBelt are the same device except the plastic balls are removed from the Sham PrenaBelt so it cannot provide pressure points.
|
|---|---|---|
|
Percentage Sleep Right
|
31.3 percentage of sleep time (%)
Standard Deviation 28.8
|
29.3 percentage of sleep time (%)
Standard Deviation 27.5
|
SECONDARY outcome
Timeframe: 1 night (approximately 8 hours)Population: Twenty (n=20) participants completed the study. Each of these participants spent two nights in the sleep lab - one night wearing the PrenaBelt and one night wearing the sham PrenaBelt. This constitutes 40 nights (20 nights with the PrenaBelt and 20 nights with the sham PrenaBelt).
This is a standard polysomnography measure of the amount of time (in minutes) that it takes a participant to transition from full wakefulness to sleep.
Outcome measures
| Measure |
PrenaBelt Night
n=20 Participants
On this night, the participants wore the PrenaBelt.
PrenaBelt: The PrenaBelt is a belt-like, positional therapy (PT) device designed specifically for pregnant women. While the PrenaBelt does not prevent the user from lying on her back or right side during sleep, it is expected to significantly decrease the amount of time she spends in these two positions via the mechanism of PT.
The PrenaBelt is worn at the level of the waist. By virtue of its design and position on the user's body, the PrenaBelt affects subtle pressure points on the back of the user when she lies on her back, activating her body's natural mechanism to spontaneously reposition itself to relieve discomfort, thereby reducing the amount of time she remains on her back.
|
Sham PrenaBelt Night
n=20 Participants
On this night, the participants wore the sham PrenaBelt.
Sham PrenaBelt: The Sham PrenaBelt and PrenaBelt are the same device except the plastic balls are removed from the Sham PrenaBelt so it cannot provide pressure points.
|
|---|---|---|
|
Sleep Latency
|
11.7 minutes
Interval 6.7 to 21.9
|
14.5 minutes
Interval 7.2 to 26.2
|
SECONDARY outcome
Timeframe: 1 night (approximately 8 hours)Population: Twenty (n=20) participants completed the study. Each of these participants spent two nights in the sleep lab - one night wearing the PrenaBelt and one night wearing the sham PrenaBelt. This constitutes 40 nights (20 nights with the PrenaBelt and 20 nights with the sham PrenaBelt).
This is a standard polysomnography measure of the percentage (%) of time the participant was asleep during the sleep test.
Outcome measures
| Measure |
PrenaBelt Night
n=20 Participants
On this night, the participants wore the PrenaBelt.
PrenaBelt: The PrenaBelt is a belt-like, positional therapy (PT) device designed specifically for pregnant women. While the PrenaBelt does not prevent the user from lying on her back or right side during sleep, it is expected to significantly decrease the amount of time she spends in these two positions via the mechanism of PT.
The PrenaBelt is worn at the level of the waist. By virtue of its design and position on the user's body, the PrenaBelt affects subtle pressure points on the back of the user when she lies on her back, activating her body's natural mechanism to spontaneously reposition itself to relieve discomfort, thereby reducing the amount of time she remains on her back.
|
Sham PrenaBelt Night
n=20 Participants
On this night, the participants wore the sham PrenaBelt.
Sham PrenaBelt: The Sham PrenaBelt and PrenaBelt are the same device except the plastic balls are removed from the Sham PrenaBelt so it cannot provide pressure points.
|
|---|---|---|
|
Sleep Efficiency
|
81 percentage of sleep time (%)
Interval 76.0 to 89.0
|
83 percentage of sleep time (%)
Interval 79.0 to 88.0
|
SECONDARY outcome
Timeframe: 1 night (approximately 8 hours)Population: Twenty (n=20) participants completed the study. Each of these participants spent two nights in the sleep lab - one night wearing the PrenaBelt and one night wearing the sham PrenaBelt. This constitutes 40 nights (20 nights with the PrenaBelt and 20 nights with the sham PrenaBelt).
This is a standard polysomnography measure of the number of times the participant was aroused from a deeper stage of NREM sleep to a lighter stage, or from REM sleep toward wakefulness. This is reported as a 'total arousal index', which is an average of the number of arousals per hour, and is further classified as a spontaneous, periodic leg movement, or respiratory arousal index.
Outcome measures
| Measure |
PrenaBelt Night
n=20 Participants
On this night, the participants wore the PrenaBelt.
PrenaBelt: The PrenaBelt is a belt-like, positional therapy (PT) device designed specifically for pregnant women. While the PrenaBelt does not prevent the user from lying on her back or right side during sleep, it is expected to significantly decrease the amount of time she spends in these two positions via the mechanism of PT.
The PrenaBelt is worn at the level of the waist. By virtue of its design and position on the user's body, the PrenaBelt affects subtle pressure points on the back of the user when she lies on her back, activating her body's natural mechanism to spontaneously reposition itself to relieve discomfort, thereby reducing the amount of time she remains on her back.
|
Sham PrenaBelt Night
n=20 Participants
On this night, the participants wore the sham PrenaBelt.
Sham PrenaBelt: The Sham PrenaBelt and PrenaBelt are the same device except the plastic balls are removed from the Sham PrenaBelt so it cannot provide pressure points.
|
|---|---|---|
|
Total Arousal Index
|
11.2 arousals per hour
Interval 8.1 to 18.0
|
12.0 arousals per hour
Interval 8.5 to 15.6
|
SECONDARY outcome
Timeframe: 1 night (approximately 8 hours)Population: Twenty (n=20) participants completed the study. Each of these participants spent two nights in the sleep lab - one night wearing the PrenaBelt and one night wearing the sham PrenaBelt. This constitutes 40 nights (20 nights with the PrenaBelt and 20 nights with the sham PrenaBelt).
This is a standard polysomnography measure of the number of times the participant was spontaneously aroused from a deeper stage of NREM sleep to a lighter stage, or from REM sleep toward wakefulness. This is reported as an 'arousal index', which is an average of the number of arousals per hour.
Outcome measures
| Measure |
PrenaBelt Night
n=20 Participants
On this night, the participants wore the PrenaBelt.
PrenaBelt: The PrenaBelt is a belt-like, positional therapy (PT) device designed specifically for pregnant women. While the PrenaBelt does not prevent the user from lying on her back or right side during sleep, it is expected to significantly decrease the amount of time she spends in these two positions via the mechanism of PT.
The PrenaBelt is worn at the level of the waist. By virtue of its design and position on the user's body, the PrenaBelt affects subtle pressure points on the back of the user when she lies on her back, activating her body's natural mechanism to spontaneously reposition itself to relieve discomfort, thereby reducing the amount of time she remains on her back.
|
Sham PrenaBelt Night
n=20 Participants
On this night, the participants wore the sham PrenaBelt.
Sham PrenaBelt: The Sham PrenaBelt and PrenaBelt are the same device except the plastic balls are removed from the Sham PrenaBelt so it cannot provide pressure points.
|
|---|---|---|
|
Spontaneous Arousal Index
|
10.5 arousals per hour
Standard Deviation 5.8
|
10.3 arousals per hour
Standard Deviation 5.5
|
SECONDARY outcome
Timeframe: 1 night (approximately 8 hours)Population: Twenty (n=20) participants completed the study. Each of these participants spent two nights in the sleep lab - one night wearing the PrenaBelt and one night wearing the sham PrenaBelt. This constitutes 40 nights (20 nights with the PrenaBelt and 20 nights with the sham PrenaBelt).
This is a standard polysomnography measure of the number of times the participant was aroused from a deeper stage of NREM sleep to a lighter stage, or from REM sleep toward wakefulness due to periodic limb movements (PLMs). This is reported as an 'arousal index', which is an average of the number of arousals per hour.
Outcome measures
| Measure |
PrenaBelt Night
n=20 Participants
On this night, the participants wore the PrenaBelt.
PrenaBelt: The PrenaBelt is a belt-like, positional therapy (PT) device designed specifically for pregnant women. While the PrenaBelt does not prevent the user from lying on her back or right side during sleep, it is expected to significantly decrease the amount of time she spends in these two positions via the mechanism of PT.
The PrenaBelt is worn at the level of the waist. By virtue of its design and position on the user's body, the PrenaBelt affects subtle pressure points on the back of the user when she lies on her back, activating her body's natural mechanism to spontaneously reposition itself to relieve discomfort, thereby reducing the amount of time she remains on her back.
|
Sham PrenaBelt Night
n=20 Participants
On this night, the participants wore the sham PrenaBelt.
Sham PrenaBelt: The Sham PrenaBelt and PrenaBelt are the same device except the plastic balls are removed from the Sham PrenaBelt so it cannot provide pressure points.
|
|---|---|---|
|
Periodic Limb Movement Arousal Index
|
0 arousals per hour
Interval 0.0 to 1.0
|
0.1 arousals per hour
Interval 0.0 to 0.7
|
SECONDARY outcome
Timeframe: 1 night (approximately 8 hours)Population: Twenty (n=20) participants completed the study. Each of these participants spent two nights in the sleep lab - one night wearing the PrenaBelt and one night wearing the sham PrenaBelt. This constitutes 40 nights (20 nights with the PrenaBelt and 20 nights with the sham PrenaBelt).
This is a standard polysomnography measure of the number of times the participant was aroused from a deeper stage of NREM sleep to a lighter stage, or from REM sleep toward wakefulness due to respiratory events. This is reported as an 'arousal index', which is an average of the number of arousals per hour.
Outcome measures
| Measure |
PrenaBelt Night
n=20 Participants
On this night, the participants wore the PrenaBelt.
PrenaBelt: The PrenaBelt is a belt-like, positional therapy (PT) device designed specifically for pregnant women. While the PrenaBelt does not prevent the user from lying on her back or right side during sleep, it is expected to significantly decrease the amount of time she spends in these two positions via the mechanism of PT.
The PrenaBelt is worn at the level of the waist. By virtue of its design and position on the user's body, the PrenaBelt affects subtle pressure points on the back of the user when she lies on her back, activating her body's natural mechanism to spontaneously reposition itself to relieve discomfort, thereby reducing the amount of time she remains on her back.
|
Sham PrenaBelt Night
n=20 Participants
On this night, the participants wore the sham PrenaBelt.
Sham PrenaBelt: The Sham PrenaBelt and PrenaBelt are the same device except the plastic balls are removed from the Sham PrenaBelt so it cannot provide pressure points.
|
|---|---|---|
|
Respiratory Arousal Index
|
0.4 arousals per hour
Interval 0.0 to 1.1
|
0.4 arousals per hour
Interval 0.0 to 1.0
|
SECONDARY outcome
Timeframe: 1 night (approximately 8 hours)Population: Twenty (n=20) participants completed the study. Each of these participants spent two nights in the sleep lab - one night wearing the PrenaBelt and one night wearing the sham PrenaBelt. This constitutes 40 nights (20 nights with the PrenaBelt and 20 nights with the sham PrenaBelt).
Percent (%) of total sleep time in sleep stage 1.
Outcome measures
| Measure |
PrenaBelt Night
n=20 Participants
On this night, the participants wore the PrenaBelt.
PrenaBelt: The PrenaBelt is a belt-like, positional therapy (PT) device designed specifically for pregnant women. While the PrenaBelt does not prevent the user from lying on her back or right side during sleep, it is expected to significantly decrease the amount of time she spends in these two positions via the mechanism of PT.
The PrenaBelt is worn at the level of the waist. By virtue of its design and position on the user's body, the PrenaBelt affects subtle pressure points on the back of the user when she lies on her back, activating her body's natural mechanism to spontaneously reposition itself to relieve discomfort, thereby reducing the amount of time she remains on her back.
|
Sham PrenaBelt Night
n=20 Participants
On this night, the participants wore the sham PrenaBelt.
Sham PrenaBelt: The Sham PrenaBelt and PrenaBelt are the same device except the plastic balls are removed from the Sham PrenaBelt so it cannot provide pressure points.
|
|---|---|---|
|
Percent Stage 1 Sleep
|
9.1 percentage of sleep time (%)
Standard Deviation 5.2
|
9.6 percentage of sleep time (%)
Standard Deviation 6.0
|
SECONDARY outcome
Timeframe: 1 night (approximately 8 hours)Population: Twenty (n=20) participants completed the study. Each of these participants spent two nights in the sleep lab - one night wearing the PrenaBelt and one night wearing the sham PrenaBelt. This constitutes 40 nights (20 nights with the PrenaBelt and 20 nights with the sham PrenaBelt).
Percent (%) of total sleep time in sleep stage 2.
Outcome measures
| Measure |
PrenaBelt Night
n=20 Participants
On this night, the participants wore the PrenaBelt.
PrenaBelt: The PrenaBelt is a belt-like, positional therapy (PT) device designed specifically for pregnant women. While the PrenaBelt does not prevent the user from lying on her back or right side during sleep, it is expected to significantly decrease the amount of time she spends in these two positions via the mechanism of PT.
The PrenaBelt is worn at the level of the waist. By virtue of its design and position on the user's body, the PrenaBelt affects subtle pressure points on the back of the user when she lies on her back, activating her body's natural mechanism to spontaneously reposition itself to relieve discomfort, thereby reducing the amount of time she remains on her back.
|
Sham PrenaBelt Night
n=20 Participants
On this night, the participants wore the sham PrenaBelt.
Sham PrenaBelt: The Sham PrenaBelt and PrenaBelt are the same device except the plastic balls are removed from the Sham PrenaBelt so it cannot provide pressure points.
|
|---|---|---|
|
Percent Stage 2 Sleep
|
64.5 percentage of sleep time (%)
Standard Deviation 7.4
|
61.0 percentage of sleep time (%)
Standard Deviation 8.1
|
SECONDARY outcome
Timeframe: 1 night (approximately 8 hours)Population: Twenty (n=20) participants completed the study. Each of these participants spent two nights in the sleep lab - one night wearing the PrenaBelt and one night wearing the sham PrenaBelt. This constitutes 40 nights (20 nights with the PrenaBelt and 20 nights with the sham PrenaBelt).
Percent (%) of total sleep time in sleep stage 3.
Outcome measures
| Measure |
PrenaBelt Night
n=20 Participants
On this night, the participants wore the PrenaBelt.
PrenaBelt: The PrenaBelt is a belt-like, positional therapy (PT) device designed specifically for pregnant women. While the PrenaBelt does not prevent the user from lying on her back or right side during sleep, it is expected to significantly decrease the amount of time she spends in these two positions via the mechanism of PT.
The PrenaBelt is worn at the level of the waist. By virtue of its design and position on the user's body, the PrenaBelt affects subtle pressure points on the back of the user when she lies on her back, activating her body's natural mechanism to spontaneously reposition itself to relieve discomfort, thereby reducing the amount of time she remains on her back.
|
Sham PrenaBelt Night
n=20 Participants
On this night, the participants wore the sham PrenaBelt.
Sham PrenaBelt: The Sham PrenaBelt and PrenaBelt are the same device except the plastic balls are removed from the Sham PrenaBelt so it cannot provide pressure points.
|
|---|---|---|
|
Percent Stage 3 Sleep
|
10.9 percentage of sleep time (%)
Standard Deviation 8.0
|
11.5 percentage of sleep time (%)
Standard Deviation 8.8
|
SECONDARY outcome
Timeframe: 1 night (approximately 8 hours)Population: Twenty (n=20) participants completed the study. Each of these participants spent two nights in the sleep lab - one night wearing the PrenaBelt and one night wearing the sham PrenaBelt. This constitutes 40 nights (20 nights with the PrenaBelt and 20 nights with the sham PrenaBelt).
Percent (%) of total sleep time in rapid eye movement (REM) sleep
Outcome measures
| Measure |
PrenaBelt Night
n=20 Participants
On this night, the participants wore the PrenaBelt.
PrenaBelt: The PrenaBelt is a belt-like, positional therapy (PT) device designed specifically for pregnant women. While the PrenaBelt does not prevent the user from lying on her back or right side during sleep, it is expected to significantly decrease the amount of time she spends in these two positions via the mechanism of PT.
The PrenaBelt is worn at the level of the waist. By virtue of its design and position on the user's body, the PrenaBelt affects subtle pressure points on the back of the user when she lies on her back, activating her body's natural mechanism to spontaneously reposition itself to relieve discomfort, thereby reducing the amount of time she remains on her back.
|
Sham PrenaBelt Night
n=20 Participants
On this night, the participants wore the sham PrenaBelt.
Sham PrenaBelt: The Sham PrenaBelt and PrenaBelt are the same device except the plastic balls are removed from the Sham PrenaBelt so it cannot provide pressure points.
|
|---|---|---|
|
Percent REM Sleep
|
15.5 percentage of sleep time (%)
Standard Deviation 6.4
|
18.0 percentage of sleep time (%)
Standard Deviation 4.6
|
SECONDARY outcome
Timeframe: 1 night (approximately 8 hours)Population: Twenty (n=20) participants completed the study. Each of these participants spent two nights in the sleep lab - one night wearing the PrenaBelt and one night wearing the sham PrenaBelt. This constitutes 40 nights (20 nights with the PrenaBelt and 20 nights with the sham PrenaBelt).
Apnea hypopnea index (AHI) is a standard polysomnography measure to indicate the severity of sleep apnea. AHI is the average number of apnea and hypopnea events per hour. Will be reported as a total AHI in units of 'events per hour'.
Outcome measures
| Measure |
PrenaBelt Night
n=20 Participants
On this night, the participants wore the PrenaBelt.
PrenaBelt: The PrenaBelt is a belt-like, positional therapy (PT) device designed specifically for pregnant women. While the PrenaBelt does not prevent the user from lying on her back or right side during sleep, it is expected to significantly decrease the amount of time she spends in these two positions via the mechanism of PT.
The PrenaBelt is worn at the level of the waist. By virtue of its design and position on the user's body, the PrenaBelt affects subtle pressure points on the back of the user when she lies on her back, activating her body's natural mechanism to spontaneously reposition itself to relieve discomfort, thereby reducing the amount of time she remains on her back.
|
Sham PrenaBelt Night
n=20 Participants
On this night, the participants wore the sham PrenaBelt.
Sham PrenaBelt: The Sham PrenaBelt and PrenaBelt are the same device except the plastic balls are removed from the Sham PrenaBelt so it cannot provide pressure points.
|
|---|---|---|
|
Apnea Hypopnea Index
|
0.5 events per hour
Interval 0.0 to 1.5
|
0.5 events per hour
Interval 0.0 to 1.5
|
SECONDARY outcome
Timeframe: 1 night (approximately 8 hours)Population: Twenty (n=20) participants completed the study. Each of these participants spent two nights in the sleep lab - one night wearing the PrenaBelt and one night wearing the sham PrenaBelt. This constitutes 40 nights (20 nights with the PrenaBelt and 20 nights with the sham PrenaBelt).
Respiratory Effort-Related Arousal (RERA) index is a standard polysomnography measure to indicate arousals from respiratory effort. Will be reported in units of 'arousals per hour'.
Outcome measures
| Measure |
PrenaBelt Night
n=20 Participants
On this night, the participants wore the PrenaBelt.
PrenaBelt: The PrenaBelt is a belt-like, positional therapy (PT) device designed specifically for pregnant women. While the PrenaBelt does not prevent the user from lying on her back or right side during sleep, it is expected to significantly decrease the amount of time she spends in these two positions via the mechanism of PT.
The PrenaBelt is worn at the level of the waist. By virtue of its design and position on the user's body, the PrenaBelt affects subtle pressure points on the back of the user when she lies on her back, activating her body's natural mechanism to spontaneously reposition itself to relieve discomfort, thereby reducing the amount of time she remains on her back.
|
Sham PrenaBelt Night
n=20 Participants
On this night, the participants wore the sham PrenaBelt.
Sham PrenaBelt: The Sham PrenaBelt and PrenaBelt are the same device except the plastic balls are removed from the Sham PrenaBelt so it cannot provide pressure points.
|
|---|---|---|
|
Respiratory Effort-Related Arousal Index
|
0 arousals per hour
Interval 0.0 to 0.1
|
0 arousals per hour
Interval 0.0 to 0.3
|
SECONDARY outcome
Timeframe: 1 night (approximately 8 hours)Population: Twenty (n=20) participants completed the study. Each of these participants spent two nights in the sleep lab - one night wearing the PrenaBelt and one night wearing the sham PrenaBelt. This constitutes 40 nights (20 nights with the PrenaBelt and 20 nights with the sham PrenaBelt).
This is a standard polysomnography measure. Like the AHI, RDI reports on respiratory events during sleep, but unlike the AHI, it also includes respiratory-effort related arousals (RERAs). RERAs are arousals from sleep that do not technically meet the definitions of apneas or hypopneas, but do disrupt sleep. Will be reported as a total RDI as well as RDI while supine and RDI while non-supine.
Outcome measures
| Measure |
PrenaBelt Night
n=20 Participants
On this night, the participants wore the PrenaBelt.
PrenaBelt: The PrenaBelt is a belt-like, positional therapy (PT) device designed specifically for pregnant women. While the PrenaBelt does not prevent the user from lying on her back or right side during sleep, it is expected to significantly decrease the amount of time she spends in these two positions via the mechanism of PT.
The PrenaBelt is worn at the level of the waist. By virtue of its design and position on the user's body, the PrenaBelt affects subtle pressure points on the back of the user when she lies on her back, activating her body's natural mechanism to spontaneously reposition itself to relieve discomfort, thereby reducing the amount of time she remains on her back.
|
Sham PrenaBelt Night
n=20 Participants
On this night, the participants wore the sham PrenaBelt.
Sham PrenaBelt: The Sham PrenaBelt and PrenaBelt are the same device except the plastic balls are removed from the Sham PrenaBelt so it cannot provide pressure points.
|
|---|---|---|
|
Respiratory Disturbance Index (RDI)
Total RDI
|
0.65 events per hour
Interval 0.0 to 1.5
|
0.55 events per hour
Interval 0.15 to 1.75
|
|
Respiratory Disturbance Index (RDI)
RDI while supine
|
0 events per hour
Interval 0.0 to 0.0
|
0 events per hour
Interval 0.0 to 1.2
|
|
Respiratory Disturbance Index (RDI)
RDI while non-supine
|
0.2 events per hour
Interval 0.0 to 1.5
|
0.5 events per hour
Interval 0.0 to 1.75
|
SECONDARY outcome
Timeframe: 1 night (approximately 8 hours)Population: Twenty (n=20) participants completed the study. Each of these participants spent two nights in the sleep lab - one night wearing the PrenaBelt and one night wearing the sham PrenaBelt. This constitutes 40 nights (20 nights with the PrenaBelt and 20 nights with the sham PrenaBelt).
SpO2 measured by fingertip pulse oximetry is a standard measure to indicate the oxygen saturation. Mean SpO2, Min SpO2, and Max SpO2 during Rapid Eye Movement (REM), and Non-REM (NREM) states.
Outcome measures
| Measure |
PrenaBelt Night
n=20 Participants
On this night, the participants wore the PrenaBelt.
PrenaBelt: The PrenaBelt is a belt-like, positional therapy (PT) device designed specifically for pregnant women. While the PrenaBelt does not prevent the user from lying on her back or right side during sleep, it is expected to significantly decrease the amount of time she spends in these two positions via the mechanism of PT.
The PrenaBelt is worn at the level of the waist. By virtue of its design and position on the user's body, the PrenaBelt affects subtle pressure points on the back of the user when she lies on her back, activating her body's natural mechanism to spontaneously reposition itself to relieve discomfort, thereby reducing the amount of time she remains on her back.
|
Sham PrenaBelt Night
n=20 Participants
On this night, the participants wore the sham PrenaBelt.
Sham PrenaBelt: The Sham PrenaBelt and PrenaBelt are the same device except the plastic balls are removed from the Sham PrenaBelt so it cannot provide pressure points.
|
|---|---|---|
|
Peripheral Blood Oxygen Saturation (SpO2)
REM maximum
|
98 percentage of SpO2 (%)
Interval 98.0 to 99.0
|
98.5 percentage of SpO2 (%)
Interval 98.0 to 99.0
|
|
Peripheral Blood Oxygen Saturation (SpO2)
REM mean
|
96 percentage of SpO2 (%)
Interval 94.9 to 96.7
|
96.3 percentage of SpO2 (%)
Interval 95.5 to 97.1
|
|
Peripheral Blood Oxygen Saturation (SpO2)
REM minimum
|
92.5 percentage of SpO2 (%)
Interval 90.8 to 94.0
|
92 percentage of SpO2 (%)
Interval 89.0 to 94.0
|
|
Peripheral Blood Oxygen Saturation (SpO2)
NREM maximum
|
99.0 percentage of SpO2 (%)
Interval 98.0 to 100.0
|
99.0 percentage of SpO2 (%)
Interval 98.0 to 100.0
|
|
Peripheral Blood Oxygen Saturation (SpO2)
NREM mean
|
96.1 percentage of SpO2 (%)
Interval 95.6 to 96.6
|
96.3 percentage of SpO2 (%)
Interval 95.7 to 97.0
|
|
Peripheral Blood Oxygen Saturation (SpO2)
NREM minimum
|
92 percentage of SpO2 (%)
Interval 91.0 to 94.0
|
92.5 percentage of SpO2 (%)
Interval 89.0 to 94.0
|
SECONDARY outcome
Timeframe: 1 night (approximately 8 hours)Population: Twenty (n=20) participants completed the study. Each of these participants spent two nights in the sleep lab - one night wearing the PrenaBelt and one night wearing the sham PrenaBelt. This constitutes 40 nights (20 nights with the PrenaBelt and 20 nights with the sham PrenaBelt).
This is a standard polysomnography measure of the presence of snoring via nasal cannula (pressure transducer) and by objective report of the research assistant (real-time audio feed).
Outcome measures
| Measure |
PrenaBelt Night
n=20 Participants
On this night, the participants wore the PrenaBelt.
PrenaBelt: The PrenaBelt is a belt-like, positional therapy (PT) device designed specifically for pregnant women. While the PrenaBelt does not prevent the user from lying on her back or right side during sleep, it is expected to significantly decrease the amount of time she spends in these two positions via the mechanism of PT.
The PrenaBelt is worn at the level of the waist. By virtue of its design and position on the user's body, the PrenaBelt affects subtle pressure points on the back of the user when she lies on her back, activating her body's natural mechanism to spontaneously reposition itself to relieve discomfort, thereby reducing the amount of time she remains on her back.
|
Sham PrenaBelt Night
n=20 Participants
On this night, the participants wore the sham PrenaBelt.
Sham PrenaBelt: The Sham PrenaBelt and PrenaBelt are the same device except the plastic balls are removed from the Sham PrenaBelt so it cannot provide pressure points.
|
|---|---|---|
|
Number of Participants With Snoring
|
15 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: 1 night (approximately 8 hours)Population: Twenty (n=20) participants completed the study. Each of these participants spent two nights in the sleep lab - one night wearing the PrenaBelt and one night wearing the sham PrenaBelt. This constitutes 40 nights (20 nights with the PrenaBelt and 20 nights with the sham PrenaBelt).
Each participant will complete the PrenaBelt User Feedback Questionnaire. On a scale of 1 to 10, participant's level of satisfaction with the PrenaBelt. Note: 1 = extremely dissatisfied 5-6 = acceptable 10 = extremely satisfied
Outcome measures
| Measure |
PrenaBelt Night
n=20 Participants
On this night, the participants wore the PrenaBelt.
PrenaBelt: The PrenaBelt is a belt-like, positional therapy (PT) device designed specifically for pregnant women. While the PrenaBelt does not prevent the user from lying on her back or right side during sleep, it is expected to significantly decrease the amount of time she spends in these two positions via the mechanism of PT.
The PrenaBelt is worn at the level of the waist. By virtue of its design and position on the user's body, the PrenaBelt affects subtle pressure points on the back of the user when she lies on her back, activating her body's natural mechanism to spontaneously reposition itself to relieve discomfort, thereby reducing the amount of time she remains on her back.
|
Sham PrenaBelt Night
n=20 Participants
On this night, the participants wore the sham PrenaBelt.
Sham PrenaBelt: The Sham PrenaBelt and PrenaBelt are the same device except the plastic balls are removed from the Sham PrenaBelt so it cannot provide pressure points.
|
|---|---|---|
|
PrenaBelt User Feedback Questionnaire - Satisfaction
|
7.5 units on a scale
Interval 6.0 to 8.3
|
7.5 units on a scale
Interval 5.5 to 9.0
|
SECONDARY outcome
Timeframe: 1 night (approximately 8 hours)Population: Twenty (n=20) participants completed the study. Each of these participants spent two nights in the sleep lab - one night wearing the PrenaBelt and one night wearing the sham PrenaBelt. This constitutes 40 nights (20 nights with the PrenaBelt and 20 nights with the sham PrenaBelt).
Each participant will complete the PrenaBelt User Feedback Questionnaire. On a scale of 1 to 10, participant's level of comfort while wearing and sleeping with the PrenaBelt. Note: 1 = extremely uncomfortable 5-6 = acceptable 10 = extremely comfortable
Outcome measures
| Measure |
PrenaBelt Night
n=20 Participants
On this night, the participants wore the PrenaBelt.
PrenaBelt: The PrenaBelt is a belt-like, positional therapy (PT) device designed specifically for pregnant women. While the PrenaBelt does not prevent the user from lying on her back or right side during sleep, it is expected to significantly decrease the amount of time she spends in these two positions via the mechanism of PT.
The PrenaBelt is worn at the level of the waist. By virtue of its design and position on the user's body, the PrenaBelt affects subtle pressure points on the back of the user when she lies on her back, activating her body's natural mechanism to spontaneously reposition itself to relieve discomfort, thereby reducing the amount of time she remains on her back.
|
Sham PrenaBelt Night
n=20 Participants
On this night, the participants wore the sham PrenaBelt.
Sham PrenaBelt: The Sham PrenaBelt and PrenaBelt are the same device except the plastic balls are removed from the Sham PrenaBelt so it cannot provide pressure points.
|
|---|---|---|
|
PrenaBelt User Feedback Questionnaire - Comfort
|
9.0 units on a scale
Interval 6.8 to 9.3
|
9 units on a scale
Interval 7.8 to 10.0
|
SECONDARY outcome
Timeframe: 1 night (approximately 8 hours)Population: Twenty (n=20) participants completed the study. Each of these participants spent two nights in the sleep lab - one night wearing the PrenaBelt and one night wearing the sham PrenaBelt. This constitutes 40 nights (20 nights with the PrenaBelt and 20 nights with the sham PrenaBelt).
Each participant will complete the PrenaBelt User Feedback Questionnaire. On a scale of 1 to 10, participant's intention to use the PrenaBelt during a subsequent pregnancy if it was available to her. Note: 1 = participant would never use it again 5-6 = participant would consider using it again 10 = participant would certainly use it again
Outcome measures
| Measure |
PrenaBelt Night
n=20 Participants
On this night, the participants wore the PrenaBelt.
PrenaBelt: The PrenaBelt is a belt-like, positional therapy (PT) device designed specifically for pregnant women. While the PrenaBelt does not prevent the user from lying on her back or right side during sleep, it is expected to significantly decrease the amount of time she spends in these two positions via the mechanism of PT.
The PrenaBelt is worn at the level of the waist. By virtue of its design and position on the user's body, the PrenaBelt affects subtle pressure points on the back of the user when she lies on her back, activating her body's natural mechanism to spontaneously reposition itself to relieve discomfort, thereby reducing the amount of time she remains on her back.
|
Sham PrenaBelt Night
n=20 Participants
On this night, the participants wore the sham PrenaBelt.
Sham PrenaBelt: The Sham PrenaBelt and PrenaBelt are the same device except the plastic balls are removed from the Sham PrenaBelt so it cannot provide pressure points.
|
|---|---|---|
|
PrenaBelt User Feedback Questionnaire - Intention to Use
|
8 units on a scale
Interval 5.8 to 8.0
|
7.0 units on a scale
Interval 6.0 to 9.0
|
SECONDARY outcome
Timeframe: 1 night (approximately 8 hours)Population: 20 participants completed the study and each spent 2 nights in the sleep lab (1 night wearing the PrenaBelt and 1 night wearing the sham PrenaBelt), which is 40 nights (40 self-reports and 40 polysomnography reports). The Arms/Groups are combined in this analysis because the treatment order was not expected to affect the accuracy of self-reporting.
To determine the accuracy of self-reported sleep behaviours against the gold-standard, polysomnography. This is the sleep onset position (left, supine, right) per the participant's self report and is compared with the sleep onset position (left, supine, right) per the polysomnography data.
Outcome measures
| Measure |
PrenaBelt Night
n=40 Nights
On this night, the participants wore the PrenaBelt.
PrenaBelt: The PrenaBelt is a belt-like, positional therapy (PT) device designed specifically for pregnant women. While the PrenaBelt does not prevent the user from lying on her back or right side during sleep, it is expected to significantly decrease the amount of time she spends in these two positions via the mechanism of PT.
The PrenaBelt is worn at the level of the waist. By virtue of its design and position on the user's body, the PrenaBelt affects subtle pressure points on the back of the user when she lies on her back, activating her body's natural mechanism to spontaneously reposition itself to relieve discomfort, thereby reducing the amount of time she remains on her back.
|
Sham PrenaBelt Night
n=40 Nights
On this night, the participants wore the sham PrenaBelt.
Sham PrenaBelt: The Sham PrenaBelt and PrenaBelt are the same device except the plastic balls are removed from the Sham PrenaBelt so it cannot provide pressure points.
|
|---|---|---|
|
Sleep Onset Position
Left
|
31 Nights
|
29 Nights
|
|
Sleep Onset Position
Supine
|
2 Nights
|
3 Nights
|
|
Sleep Onset Position
Right
|
7 Nights
|
8 Nights
|
|
Sleep Onset Position
Prone
|
0 Nights
|
0 Nights
|
SECONDARY outcome
Timeframe: 1 night (approximately 8 hours)Population: 20 participants completed the study and each spent 2 nights in the sleep lab (1 night wearing the PrenaBelt and 1 night wearing the sham PrenaBelt), which is 40 nights (40 self-reports and 40 polysomnography reports). The Arms/Groups are combined in this analysis because the treatment order was not expected to affect the accuracy of self-reporting.
To determine the accuracy of self-reported sleep behaviours against the gold-standard, polysomnography. This is the participant's waking position (left, supine, right, prone) per the participant's self report and is compared with the waking position (left, supine, right, prone) per the polysomnography data.
Outcome measures
| Measure |
PrenaBelt Night
n=40 Nights
On this night, the participants wore the PrenaBelt.
PrenaBelt: The PrenaBelt is a belt-like, positional therapy (PT) device designed specifically for pregnant women. While the PrenaBelt does not prevent the user from lying on her back or right side during sleep, it is expected to significantly decrease the amount of time she spends in these two positions via the mechanism of PT.
The PrenaBelt is worn at the level of the waist. By virtue of its design and position on the user's body, the PrenaBelt affects subtle pressure points on the back of the user when she lies on her back, activating her body's natural mechanism to spontaneously reposition itself to relieve discomfort, thereby reducing the amount of time she remains on her back.
|
Sham PrenaBelt Night
n=40 Nights
On this night, the participants wore the sham PrenaBelt.
Sham PrenaBelt: The Sham PrenaBelt and PrenaBelt are the same device except the plastic balls are removed from the Sham PrenaBelt so it cannot provide pressure points.
|
|---|---|---|
|
Waking Position
Left
|
28 Nights
|
22 Nights
|
|
Waking Position
Supine
|
0 Nights
|
5 Nights
|
|
Waking Position
Right
|
12 Nights
|
13 Nights
|
|
Waking Position
Prone
|
0 Nights
|
0 Nights
|
SECONDARY outcome
Timeframe: 1 night (approximately 8 hours)Population: Only 15 participants completed this question; each of these spent 2 nights in the sleep lab (1 PrenaBelt night and 1 sham PrenaBelt night), which is 30 nights (30 self-reports and 30 polysomnography reports). The Arms/Groups are combined in this analysis because the treatment order was not expected to affect the accuracy of self-reporting.
To determine the accuracy of self-reported sleep behaviours against the gold-standard, polysomnography. This is the number of times the participant changed body position (e.g., supine to left side) per the participant's self report and is compared with the number of times the participant changed body position per the polysomnography data.
Outcome measures
| Measure |
PrenaBelt Night
n=30 Nights
On this night, the participants wore the PrenaBelt.
PrenaBelt: The PrenaBelt is a belt-like, positional therapy (PT) device designed specifically for pregnant women. While the PrenaBelt does not prevent the user from lying on her back or right side during sleep, it is expected to significantly decrease the amount of time she spends in these two positions via the mechanism of PT.
The PrenaBelt is worn at the level of the waist. By virtue of its design and position on the user's body, the PrenaBelt affects subtle pressure points on the back of the user when she lies on her back, activating her body's natural mechanism to spontaneously reposition itself to relieve discomfort, thereby reducing the amount of time she remains on her back.
|
Sham PrenaBelt Night
n=30 Nights
On this night, the participants wore the sham PrenaBelt.
Sham PrenaBelt: The Sham PrenaBelt and PrenaBelt are the same device except the plastic balls are removed from the Sham PrenaBelt so it cannot provide pressure points.
|
|---|---|---|
|
Number of Position Changes
|
3 position changes
Interval 2.0 to 4.0
|
6 position changes
Interval 3.3 to 10.0
|
SECONDARY outcome
Timeframe: 1 night (approximately 8 hours)Population: Of 18 participants that answered this question, all except 1 of these participants answered it on both nights, which yields 35 nights (35 self-reports and 35 polysomnography reports). The Arms/Groups are combined in this analysis because the treatment order was not expected to affect the accuracy of self-reporting.
To determine the accuracy of self-reported sleep behaviours against the gold-standard, polysomnography. This is the percentage (%) of total sleep time in each position (left, supine, right, prone) per the participant's self report and is compared with the percentage (%) of total sleep time in each position (left, supine, right, prone) per the polysomnography data.
Outcome measures
| Measure |
PrenaBelt Night
n=35 Nights
On this night, the participants wore the PrenaBelt.
PrenaBelt: The PrenaBelt is a belt-like, positional therapy (PT) device designed specifically for pregnant women. While the PrenaBelt does not prevent the user from lying on her back or right side during sleep, it is expected to significantly decrease the amount of time she spends in these two positions via the mechanism of PT.
The PrenaBelt is worn at the level of the waist. By virtue of its design and position on the user's body, the PrenaBelt affects subtle pressure points on the back of the user when she lies on her back, activating her body's natural mechanism to spontaneously reposition itself to relieve discomfort, thereby reducing the amount of time she remains on her back.
|
Sham PrenaBelt Night
n=35 Nights
On this night, the participants wore the sham PrenaBelt.
Sham PrenaBelt: The Sham PrenaBelt and PrenaBelt are the same device except the plastic balls are removed from the Sham PrenaBelt so it cannot provide pressure points.
|
|---|---|---|
|
Percentage of Total Sleep Time in Each Position
Left
|
59.9 percentage of sleep time (%)
Standard Deviation 28.1
|
54.4 percentage of sleep time (%)
Standard Deviation 26.4
|
|
Percentage of Total Sleep Time in Each Position
Supine
|
7.8 percentage of sleep time (%)
Standard Deviation 20.0
|
14.8 percentage of sleep time (%)
Standard Deviation 18.7
|
|
Percentage of Total Sleep Time in Each Position
Right
|
31.3 percentage of sleep time (%)
Standard Deviation 27.3
|
30.8 percentage of sleep time (%)
Standard Deviation 28.5
|
|
Percentage of Total Sleep Time in Each Position
Prone
|
0 percentage of sleep time (%)
Standard Deviation 0
|
0 percentage of sleep time (%)
Standard Deviation 0
|
Adverse Events
PrenaBelt on First Night, Sham PrenaBelt on Second Night
Sham PrenaBelt on First Night, PrenaBelt on Second Night
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Allan Kember, Director of Programs
Global Innovations for Reproductive Health & Life
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place