Trial Outcomes & Findings for Alice PDx User/Validation Extended Trial (NCT NCT00841906)
NCT ID: NCT00841906
Last Updated: 2018-11-19
Results Overview
The Apnea-Hypopnea Index (AHI) is an index used to indicate the severity of sleep apnea. It is represented by the number of apnea and hypopnea events per hour of sleep. The AHI detected events of Alice 5 system was compared to the AHI events of the Alice PDx.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
32 participants
Primary outcome timeframe
Lab Night
Results posted on
2018-11-19
Participant Flow
Participant milestones
| Measure |
Alice PDx With Only Written Instructions
Participants will be asked to follow the Alice PDx user instructions to apply basic leads and sensors and undergo a sleep study in their home. Participants will receive little or no instruction concerning the set up of the Alice PDx device.
Alice PDx with only written instructions: Participants will be asked to follow the Alice PDx user instructions to apply basic leads and sensors and undergo a sleep study in their home. Participants will receive little or no instruction concerning the set up of the Alice PDx device. After the Alice PDx home study has proven successful, participants will return to the sleep center to undergo a second sleep study, the Lab Night, in which simultaneous monitoring with the Alice PDx and Alice 5 will be performed.
|
Alice PDx With Written and Verbal Instructions
Participants will be asked to follow the Alice PDx user instructions to apply basic leads and sensors and undergo a sleep study in their home. Participants will receive little or no instruction concerning the set up of the Alice PDx device.
Alice PDx with written and verbal instructions: Participants will be provided instruction by a trained sleep professional on the set up of the Alice PDx device. They will then be asked to follow the instructions for the Alice PDx device, if necessary, and undergo a sleep study in their home. After the Alice PDx home study has proven successful, participants will return to the sleep center to undergo a second sleep study, the Lab Night, in which simultaneous monitoring with the Alice PDx and Alice 5 will be performed.
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|---|---|---|
|
Overall Study
STARTED
|
18
|
14
|
|
Overall Study
COMPLETED
|
16
|
14
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Alice PDx With Only Written Instructions
Participants will be asked to follow the Alice PDx user instructions to apply basic leads and sensors and undergo a sleep study in their home. Participants will receive little or no instruction concerning the set up of the Alice PDx device.
Alice PDx with only written instructions: Participants will be asked to follow the Alice PDx user instructions to apply basic leads and sensors and undergo a sleep study in their home. Participants will receive little or no instruction concerning the set up of the Alice PDx device. After the Alice PDx home study has proven successful, participants will return to the sleep center to undergo a second sleep study, the Lab Night, in which simultaneous monitoring with the Alice PDx and Alice 5 will be performed.
|
Alice PDx With Written and Verbal Instructions
Participants will be asked to follow the Alice PDx user instructions to apply basic leads and sensors and undergo a sleep study in their home. Participants will receive little or no instruction concerning the set up of the Alice PDx device.
Alice PDx with written and verbal instructions: Participants will be provided instruction by a trained sleep professional on the set up of the Alice PDx device. They will then be asked to follow the instructions for the Alice PDx device, if necessary, and undergo a sleep study in their home. After the Alice PDx home study has proven successful, participants will return to the sleep center to undergo a second sleep study, the Lab Night, in which simultaneous monitoring with the Alice PDx and Alice 5 will be performed.
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|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
Baseline Characteristics
Alice PDx User/Validation Extended Trial
Baseline characteristics by cohort
| Measure |
Alice PDx With Only Written Instructions
n=18 Participants
Participants will be asked to follow the Alice PDx user instructions to apply basic leads and sensors and undergo a sleep study in their home. Participants will receive little or no instruction concerning the set up of the Alice PDx device.
Alice PDx with only written instructions: Participants will be asked to follow the Alice PDx user instructions to apply basic leads and sensors and undergo a sleep study in their home. Participants will receive little or no instruction concerning the set up of the Alice PDx device. After the Alice PDx home study has proven successful, participants will return to the sleep center to undergo a second sleep study, the Lab Night, in which simultaneous monitoring with the Alice PDx and Alice 5 will be performed.
|
Alice PDx With Written and Verbal Instructions
n=14 Participants
Participants will be asked to follow the Alice PDx user instructions to apply basic leads and sensors and undergo a sleep study in their home. Participants will receive little or no instruction concerning the set up of the Alice PDx device.
Alice PDx with written and verbal instructions: Participants will be provided instruction by a trained sleep professional on the set up of the Alice PDx device. They will then be asked to follow the instructions for the Alice PDx device, if necessary, and undergo a sleep study in their home. After the Alice PDx home study has proven successful, participants will return to the sleep center to undergo a second sleep study, the Lab Night, in which simultaneous monitoring with the Alice PDx and Alice 5 will be performed.
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=99 Participants
|
14 participants
n=107 Participants
|
32 participants
n=206 Participants
|
|
Body Mass Index
|
35.4 kg/m^2
STANDARD_DEVIATION 8.8 • n=99 Participants
|
32.6 kg/m^2
STANDARD_DEVIATION 6.6 • n=107 Participants
|
34.2 kg/m^2
STANDARD_DEVIATION 7.9 • n=206 Participants
|
|
Smoking Status
Smokers
|
2 participants
n=99 Participants
|
5 participants
n=107 Participants
|
7 participants
n=206 Participants
|
|
Smoking Status
Non-Smokers
|
16 participants
n=99 Participants
|
9 participants
n=107 Participants
|
23 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Lab NightPopulation: All participants that completed the overnight portion of the study were analyzed, they each had an Alice 5 System night and an Alice PDx night.
The Apnea-Hypopnea Index (AHI) is an index used to indicate the severity of sleep apnea. It is represented by the number of apnea and hypopnea events per hour of sleep. The AHI detected events of Alice 5 system was compared to the AHI events of the Alice PDx.
Outcome measures
| Measure |
Alice 5 System
n=30 Participants
All participants in the lab night portion of the study will wear an Alice 5 System and an Alice PDx for comparison of the two devices.
|
Alice PDx
n=30 Participants
All participants in the lab night portion of the study will wear an Alice 5 System and an Alice PDx for comparison of the two devices.
|
|---|---|---|
|
This Study Will Compare the Apnea Hypopnea Index Recorded by the Alice PDx to the Physiological Data Recorded by Its Predicate Device the Alice 5 System and Validate Its Equivalence.
|
13.16 events
Standard Deviation 24.69
|
20.24 events
Standard Deviation 24.88
|
PRIMARY outcome
Timeframe: Lab NightPopulation: All participants that completed the overnight portion of the study were analyzed.
The central apnea index, hypopnea index, mixed apnea index and obstructive apnea indexes are all values that are calculated by determining the type of apneic event (apnea, hypopnea, mixed or obstructive). Each type of event is added up over the night and divided by the number of hours. For this analysis each index was compared between both devices.
Outcome measures
| Measure |
Alice 5 System
n=30 Participants
All participants in the lab night portion of the study will wear an Alice 5 System and an Alice PDx for comparison of the two devices.
|
Alice PDx
n=30 Participants
All participants in the lab night portion of the study will wear an Alice 5 System and an Alice PDx for comparison of the two devices.
|
|---|---|---|
|
This Study Will Compare the Central Apnea Index, Hypopnea Index, Mixed Apnea Index and Obstructive Apnea Index Recorded by the Alice PDx to the Physiological Data Recorded by Its Predicate Device the Alice 5 System and Validate Its Equivalence.
Central Apnea Index
|
.18 events/hour
Standard Deviation .42
|
.92 events/hour
Standard Deviation 2.64
|
|
This Study Will Compare the Central Apnea Index, Hypopnea Index, Mixed Apnea Index and Obstructive Apnea Index Recorded by the Alice PDx to the Physiological Data Recorded by Its Predicate Device the Alice 5 System and Validate Its Equivalence.
Hypopnea index
|
6.91 events/hour
Standard Deviation 8.33
|
7.15 events/hour
Standard Deviation 4.8
|
|
This Study Will Compare the Central Apnea Index, Hypopnea Index, Mixed Apnea Index and Obstructive Apnea Index Recorded by the Alice PDx to the Physiological Data Recorded by Its Predicate Device the Alice 5 System and Validate Its Equivalence.
Mixed Apnea Index
|
.12 events/hour
Standard Deviation .38
|
.21 events/hour
Standard Deviation .52
|
|
This Study Will Compare the Central Apnea Index, Hypopnea Index, Mixed Apnea Index and Obstructive Apnea Index Recorded by the Alice PDx to the Physiological Data Recorded by Its Predicate Device the Alice 5 System and Validate Its Equivalence.
Obstructive Apnea Index
|
5.95 events/hour
Standard Deviation 17.54
|
11.97 events/hour
Standard Deviation 21.39
|
PRIMARY outcome
Timeframe: Lab NightPopulation: All participants that completed the overnight portion of the study were analyzed.
This study will compare different measurements recorded which include Time in Bed, Stage N1, Stage N2, Stage N3, REM, Sleep Onset Latency, Total Sleep Time, Wake Time in Bed and Wake After Sleep Onset by the Alice PDx to the measurement data recorded by its predicate device the Alice 5 System and validate its equivalence.
Outcome measures
| Measure |
Alice 5 System
n=30 Participants
All participants in the lab night portion of the study will wear an Alice 5 System and an Alice PDx for comparison of the two devices.
|
Alice PDx
n=30 Participants
All participants in the lab night portion of the study will wear an Alice 5 System and an Alice PDx for comparison of the two devices.
|
|---|---|---|
|
This Study Will Compare Different Measurements Recorded by the Alice PDx to the Measurement Data Recorded by Its Predicate Device the Alice 5 System and Validate Its Equivalence.
Time In Bed
|
308.61 minutes
Standard Deviation 385.32
|
178.49 minutes
Standard Deviation 209.16
|
|
This Study Will Compare Different Measurements Recorded by the Alice PDx to the Measurement Data Recorded by Its Predicate Device the Alice 5 System and Validate Its Equivalence.
Time spent in Stage N1
|
5.82 minutes
Standard Deviation 4.25
|
5.43 minutes
Standard Deviation 2.73
|
|
This Study Will Compare Different Measurements Recorded by the Alice PDx to the Measurement Data Recorded by Its Predicate Device the Alice 5 System and Validate Its Equivalence.
Time spent in Stage N2
|
52.50 minutes
Standard Deviation 13.51
|
51.05 minutes
Standard Deviation 9.59
|
|
This Study Will Compare Different Measurements Recorded by the Alice PDx to the Measurement Data Recorded by Its Predicate Device the Alice 5 System and Validate Its Equivalence.
Time spent in Stage N3
|
13.03 minutes
Standard Deviation 8.61
|
13.54 minutes
Standard Deviation 9.29
|
|
This Study Will Compare Different Measurements Recorded by the Alice PDx to the Measurement Data Recorded by Its Predicate Device the Alice 5 System and Validate Its Equivalence.
Time spent in Rapid Eye Movement (REM)
|
12.14 minutes
Standard Deviation 6.88
|
11.74 minutes
Standard Deviation 5.63
|
|
This Study Will Compare Different Measurements Recorded by the Alice PDx to the Measurement Data Recorded by Its Predicate Device the Alice 5 System and Validate Its Equivalence.
Sleep Onset Latency
|
16.98 minutes
Standard Deviation 15.39
|
16.83 minutes
Standard Deviation 14.35
|
|
This Study Will Compare Different Measurements Recorded by the Alice PDx to the Measurement Data Recorded by Its Predicate Device the Alice 5 System and Validate Its Equivalence.
Total Sleep Time
|
319.88 minutes
Standard Deviation 54.55
|
314.93 minutes
Standard Deviation 58.56
|
|
This Study Will Compare Different Measurements Recorded by the Alice PDx to the Measurement Data Recorded by Its Predicate Device the Alice 5 System and Validate Its Equivalence.
Wake Time in Bed
|
16.49 minutes
Standard Deviation 12.24
|
18.23 minutes
Standard Deviation 12.04
|
|
This Study Will Compare Different Measurements Recorded by the Alice PDx to the Measurement Data Recorded by Its Predicate Device the Alice 5 System and Validate Its Equivalence.
Wake After Sleep Onset
|
50.57 minutes
Standard Deviation 46.5
|
55.70 minutes
Standard Deviation 46.09
|
SECONDARY outcome
Timeframe: Lab NightPopulation: 3 participants were not able to provide usable GSI data.
The Alice PDx incorporates a unique Good Study Indicator (GSI). The GSI is a predicated on airflow and oximeter signal quality and displays the amount of "good quality data" needed for a study to be complete and valid. The GSI visually displays the amount of good quality data in 25-percent increments on the Alice PDx screen. For purposes of this secondary objective this number was compared from participants who set-up and wore the device at home and those that wore the device in a sleep lab set up by a sleep technician.
Outcome measures
| Measure |
Alice 5 System
n=27 Participants
All participants in the lab night portion of the study will wear an Alice 5 System and an Alice PDx for comparison of the two devices.
|
Alice PDx
n=27 Participants
All participants in the lab night portion of the study will wear an Alice 5 System and an Alice PDx for comparison of the two devices.
|
|---|---|---|
|
The Secondary Objective of This Study is to Compare the Measurements of the Alice PDx When Patients Complete the Set-up of the Device at Home and When Patients Are Set up by a Sleep Technician in the Sleep Laboratory.
|
88.9 percentage of average GSI
Standard Deviation 17.4
|
70.3 percentage of average GSI
Standard Deviation 31.1
|
Adverse Events
Alice PDx With Only Written Instructions
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Alice PDx With Written and Verbal Instructions
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Alice PDx With Only Written Instructions
n=18 participants at risk
Participants will be asked to follow the Alice PDx user instructions to apply basic leads and sensors and undergo a sleep study in their home. Participants will receive little or no instruction concerning the set up of the Alice PDx device.
Alice PDx with only written instructions: Participants will be asked to follow the Alice PDx user instructions to apply basic leads and sensors and undergo a sleep study in their home. Participants will receive little or no instruction concerning the set up of the Alice PDx device. After the Alice PDx home study has proven successful, participants will return to the sleep center to undergo a second sleep study, the Lab Night, in which simultaneous monitoring with the Alice PDx and Alice 5 will be performed.
|
Alice PDx With Written and Verbal Instructions
n=14 participants at risk
Participants will be asked to follow the Alice PDx user instructions to apply basic leads and sensors and undergo a sleep study in their home. Participants will receive little or no instruction concerning the set up of the Alice PDx device.
Alice PDx with written and verbal instructions: Participants will be provided instruction by a trained sleep professional on the set up of the Alice PDx device. They will then be asked to follow the instructions for the Alice PDx device, if necessary, and undergo a sleep study in their home. After the Alice PDx home study has proven successful, participants will return to the sleep center to undergo a second sleep study, the Lab Night, in which simultaneous monitoring with the Alice PDx and Alice 5 will be performed.
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|---|---|---|
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Nervous system disorders
Headache
|
5.6%
1/18 • Number of events 1
|
0.00%
0/14
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place