Trial Outcomes & Findings for Hill-Rom WAVE for Positional Obstructive Sleep Apnea at Home (NCT NCT03971721)
NCT ID: NCT03971721
Last Updated: 2021-03-16
Results Overview
Apnea-Hypopnea Index derived from Home Sleep Test. The apnea-hypopnea index (AHI) is the combined average number of apneas and hypopneas that occur per hour of sleep between two nights. AHI\<5 is indicative of no sleep apnea, AHI 5-15 is indicative of mild sleep apnea, AHI 15-30 is indicative of moderate sleep apnea, AHI\>30 is indicative of severe sleep apnea. The minimum AHI is 0, and there is no maximum. A higher score means a worse outcome. Subscales are not used to compute the value. The difference was calculated based on the value at night 1 minus the value at night 2 (converted to a positive value if the difference created a negative value). The mean value was calculated by adding the difference based on the total number of participants.
TERMINATED
NA
3 participants
2 nights
2021-03-16
Participant Flow
Early termination of study by the sponsor limited the number of participants recruited.
Participant milestones
| Measure |
Wave Mattress Support
The mattress support will be delivered at the subject's home by professional staff of the sponsor (Hill-Rom) in the presence of the research coordinator or investigator. Subject will sleep on mattress support for the duration of study participation.
Wave 4.3: The Wave 4.3 mattress support is an insert, placed underneath the user's existing mattress, that when inflated increases the longitudinal incline of the mattress support, increasing in inclination in the direction of the head of the bed. The resulting mattress contours are such that the mattress has a lateral inclination of approximately 15 degrees in the head section and 10 degrees in the torso section. In addition to the features allowing the user to activate and deactivate creation of this Graduated Lateral RotationTM orientation, this device has sensors and monitoring system allowing for remotely monitoring the status of the system, including confirming that the supports are achieving the prescribed support angles and that the system is working as planned.
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|---|---|
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Overall Study
STARTED
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3
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Overall Study
COMPLETED
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3
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Wave Mattress Support
n=3 Participants
The mattress support will be delivered at the subject's home by professional staff of the sponsor (Hill-Rom) in the presence of the research coordinator or investigator. Subject will sleep on mattress support for the duration of study participation.
Wave 4.3: The Wave 4.3 mattress support is an insert, placed underneath the user's existing mattress, that when inflated increases the longitudinal incline of the mattress support, increasing in inclination in the direction of the head of the bed. The resulting mattress contours are such that the mattress has a lateral inclination of approximately 15 degrees in the head section and 10 degrees in the torso section. In addition to the features allowing the user to activate and deactivate creation of this Graduated Lateral RotationTM orientation, this device has sensors and monitoring system allowing for remotely monitoring the status of the system, including confirming that the supports are achieving the prescribed support angles, and that the system is working as planned.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=3 Participants
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Age, Categorical
Between 18 and 65 years
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3 Participants
n=3 Participants
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Age, Categorical
>=65 years
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0 Participants
n=3 Participants
|
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Age, Continuous
|
39.7 years
n=3 Participants
|
|
Sex: Female, Male
Female
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0 Participants
n=3 Participants
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Sex: Female, Male
Male
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3 Participants
n=3 Participants
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Region of Enrollment
United States
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3 participants
n=3 Participants
|
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Enrolled Participants
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3 Participants
n=3 Participants
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PRIMARY outcome
Timeframe: 2 nightsApnea-Hypopnea Index derived from Home Sleep Test. The apnea-hypopnea index (AHI) is the combined average number of apneas and hypopneas that occur per hour of sleep between two nights. AHI\<5 is indicative of no sleep apnea, AHI 5-15 is indicative of mild sleep apnea, AHI 15-30 is indicative of moderate sleep apnea, AHI\>30 is indicative of severe sleep apnea. The minimum AHI is 0, and there is no maximum. A higher score means a worse outcome. Subscales are not used to compute the value. The difference was calculated based on the value at night 1 minus the value at night 2 (converted to a positive value if the difference created a negative value). The mean value was calculated by adding the difference based on the total number of participants.
Outcome measures
| Measure |
Wave Mattress Support
n=3 Participants
The mattress support will be delivered at the subject's home by professional staff of the sponsor (Hill-Rom) in the presence of the research coordinator or investigator. Subject will sleep on mattress support for the duration of study participation.
Wave 4.3: The Wave 4.3 mattress support is an insert, placed underneath the user's existing mattress, that when inflated increases the longitudinal incline of the mattress support, increasing in inclination in the direction of the head of the bed. The resulting mattress contours are such that the mattress has a lateral inclination of approximately 15 degrees in the head section and 10 degrees in the torso section. In addition to the features allowing the user to activate and deactivate creation of this Graduated Lateral RotationTM orientation, this device has sensors and monitoring system allowing for remotely monitoring the status of the system, including confirming that the supports are achieving the prescribed support angles, and that the system is working as planned.
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Apnea-Hypopnea Index Difference Between Two Nights
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2.03 events per hour
Standard Deviation 4.20
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SECONDARY outcome
Timeframe: 2 nightsOxygen Desaturation Index calculated based on the average between two nights measured. Desaturation episodes are generally described as a decrease in the mean oxygen saturation of ≥4% (over the last 120 seconds) that lasts for at least 10 seconds. ODI values can range from 0 to greater than 30. A higher score means a worse outcome. Subscales are not used to compute the value. The difference was calculated based on the value at night 1 minus the value at night 2 (converted to a positive value if the difference created a negative value). The mean value was calculated by adding the difference based on the total number of participants.
Outcome measures
| Measure |
Wave Mattress Support
n=3 Participants
The mattress support will be delivered at the subject's home by professional staff of the sponsor (Hill-Rom) in the presence of the research coordinator or investigator. Subject will sleep on mattress support for the duration of study participation.
Wave 4.3: The Wave 4.3 mattress support is an insert, placed underneath the user's existing mattress, that when inflated increases the longitudinal incline of the mattress support, increasing in inclination in the direction of the head of the bed. The resulting mattress contours are such that the mattress has a lateral inclination of approximately 15 degrees in the head section and 10 degrees in the torso section. In addition to the features allowing the user to activate and deactivate creation of this Graduated Lateral RotationTM orientation, this device has sensors and monitoring system allowing for remotely monitoring the status of the system, including confirming that the supports are achieving the prescribed support angles, and that the system is working as planned.
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Oxygen Desaturation Index Difference Between Two Nights
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1.33 units on a scale
Standard Deviation 4.25
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SECONDARY outcome
Timeframe: Completed at Visit 1 and Visit 4 (~5 minutes)A subjective measure of sleepiness on average based on the total score. The score ranges from a minimum of 0 to a maximum of 24. A higher score means a worse outcome. Subscales are not used to compute the value. The difference was calculated based on the value at visit 1 minus the value at visit 4 (converted to a positive value if the difference created a negative value). The mean value was calculated by adding the difference based on the total number of participants.
Outcome measures
| Measure |
Wave Mattress Support
n=3 Participants
The mattress support will be delivered at the subject's home by professional staff of the sponsor (Hill-Rom) in the presence of the research coordinator or investigator. Subject will sleep on mattress support for the duration of study participation.
Wave 4.3: The Wave 4.3 mattress support is an insert, placed underneath the user's existing mattress, that when inflated increases the longitudinal incline of the mattress support, increasing in inclination in the direction of the head of the bed. The resulting mattress contours are such that the mattress has a lateral inclination of approximately 15 degrees in the head section and 10 degrees in the torso section. In addition to the features allowing the user to activate and deactivate creation of this Graduated Lateral RotationTM orientation, this device has sensors and monitoring system allowing for remotely monitoring the status of the system, including confirming that the supports are achieving the prescribed support angles, and that the system is working as planned.
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Epworth Sleepiness Score
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6.67 units on a scale
Standard Deviation 3.21
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SECONDARY outcome
Timeframe: Completed at Visit 2 and Visit 4 (~5 minutes)A subjective measure of sleepiness on daytime function with an average of the total score. The score ranges from a minimum of 0 to a maximum of 20. A higher score means a better outcome. Subscales are not used to compute the value. The difference was calculated based on the value at visit 2 minus the value at visit 4 (converted to a positive value if the difference created a negative value). The difference was calculated based on the value at visit 2 minus the value at visit 4 (converted to a positive value if the difference created a negative value). The mean value was calculated by adding the difference based on the total number of participants.
Outcome measures
| Measure |
Wave Mattress Support
n=3 Participants
The mattress support will be delivered at the subject's home by professional staff of the sponsor (Hill-Rom) in the presence of the research coordinator or investigator. Subject will sleep on mattress support for the duration of study participation.
Wave 4.3: The Wave 4.3 mattress support is an insert, placed underneath the user's existing mattress, that when inflated increases the longitudinal incline of the mattress support, increasing in inclination in the direction of the head of the bed. The resulting mattress contours are such that the mattress has a lateral inclination of approximately 15 degrees in the head section and 10 degrees in the torso section. In addition to the features allowing the user to activate and deactivate creation of this Graduated Lateral RotationTM orientation, this device has sensors and monitoring system allowing for remotely monitoring the status of the system, including confirming that the supports are achieving the prescribed support angles, and that the system is working as planned.
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Functional Outcomes of Sleep Questionnaire Score
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2.00 score on a scale
Standard Deviation 1.41
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SECONDARY outcome
Timeframe: Completed at Visit 2 and Visit 4 (~5 minutes)A subjective measure of sleepiness with the average of the total score. The score ranges from a minimum of 0 to a maximum of 100. A higher score means a better outcome. Subscales are not used to compute the value. The difference was calculated based on the value at visit 2 minus the value at visit 4 (converted to a positive value if the difference created a negative value). The mean value was calculated by adding the difference based on the total number of participants.
Outcome measures
| Measure |
Wave Mattress Support
n=3 Participants
The mattress support will be delivered at the subject's home by professional staff of the sponsor (Hill-Rom) in the presence of the research coordinator or investigator. Subject will sleep on mattress support for the duration of study participation.
Wave 4.3: The Wave 4.3 mattress support is an insert, placed underneath the user's existing mattress, that when inflated increases the longitudinal incline of the mattress support, increasing in inclination in the direction of the head of the bed. The resulting mattress contours are such that the mattress has a lateral inclination of approximately 15 degrees in the head section and 10 degrees in the torso section. In addition to the features allowing the user to activate and deactivate creation of this Graduated Lateral RotationTM orientation, this device has sensors and monitoring system allowing for remotely monitoring the status of the system, including confirming that the supports are achieving the prescribed support angles, and that the system is working as planned.
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|---|---|
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Visual Analog Scale Score
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34 percentage of sleep quality
Standard Deviation 0
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Adverse Events
Wave Mattress Support
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place