Trial Outcomes & Findings for Positive Pressure Treatment of Obstructive Sleep Apnea (NCT NCT00636181)
NCT ID: NCT00636181
Last Updated: 2019-08-13
Results Overview
The Apnea-Hyopnea Index is the number of average number of apneas (complete pauses in breathing lasting at least 10 seconds) and hypopneas (decreases in airflow lasting at least 10 seconds) per hour of sleep. This data was compared from the polysomnography (sleep study) data after the first night of device use and at 180 days
COMPLETED
NA
168 participants
Baseline and 180 Days
2019-08-13
Participant Flow
Patients who completed routine clinical diagnostic visit and CPAP titration polysomnography (PSG) at 5 international sleep centers were consecutively recruited for the study. These patients were approached with information on the study and were asked to consent to participate.
168 participants were enrolled into the study. However 4 participants were excluded from the analysis and demographic data because they withdrew from the trial prior to any study procedures.
Participant milestones
| Measure |
Auto Aflex
auto adjusting positive pressure therapy with AFLEX
Auto AFlex: Positive pressure therapy treatment
|
Auto CPAP
auto adjusting positive pressure therapy
Auto CPAP: Positive pressure therapy treatment
|
CPAP
continuous positive airway pressure
CPAP: Positive pressure therapy treatment
|
|---|---|---|---|
|
Overall Study
STARTED
|
54
|
53
|
57
|
|
Overall Study
COMPLETED
|
46
|
47
|
47
|
|
Overall Study
NOT COMPLETED
|
8
|
6
|
10
|
Reasons for withdrawal
| Measure |
Auto Aflex
auto adjusting positive pressure therapy with AFLEX
Auto AFlex: Positive pressure therapy treatment
|
Auto CPAP
auto adjusting positive pressure therapy
Auto CPAP: Positive pressure therapy treatment
|
CPAP
continuous positive airway pressure
CPAP: Positive pressure therapy treatment
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
8
|
6
|
10
|
Baseline Characteristics
Positive Pressure Treatment of Obstructive Sleep Apnea
Baseline characteristics by cohort
| Measure |
Auto Aflex
n=54 Participants
auto adjusting positive pressure therapy with AFLEX
Auto AFlex: Positive pressure therapy treatment
|
Auto CPAP
n=53 Participants
auto adjusting positive pressure therapy
Auto CPAP: Positive pressure therapy treatment
|
CPAP
n=57 Participants
continuous positive airway pressure
CPAP: Positive pressure therapy treatment
|
Total
n=164 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
49.1 years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
48.3 years
STANDARD_DEVIATION 10.0 • n=7 Participants
|
48.8 years
STANDARD_DEVIATION 12.0 • n=5 Participants
|
48.9 years
STANDARD_DEVIATION 11.2 • n=4 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
124 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
46 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
135 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
39 participants
n=5 Participants
|
44 participants
n=7 Participants
|
45 participants
n=5 Participants
|
128 participants
n=4 Participants
|
|
Region of Enrollment
Germany
|
15 participants
n=5 Participants
|
9 participants
n=7 Participants
|
12 participants
n=5 Participants
|
36 participants
n=4 Participants
|
|
Apnea-Hypopnea Index
|
36.87 events/hour
STANDARD_DEVIATION 30 • n=5 Participants
|
37.29 events/hour
STANDARD_DEVIATION 31.1 • n=7 Participants
|
41.08 events/hour
STANDARD_DEVIATION 31.57 • n=5 Participants
|
38.52 events/hour
STANDARD_DEVIATION 30.6 • n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and 180 DaysPopulation: During the course of the study 24 participants withdrew from the study.
The Apnea-Hyopnea Index is the number of average number of apneas (complete pauses in breathing lasting at least 10 seconds) and hypopneas (decreases in airflow lasting at least 10 seconds) per hour of sleep. This data was compared from the polysomnography (sleep study) data after the first night of device use and at 180 days
Outcome measures
| Measure |
Auto Aflex
n=54 Participants
auto adjusting positive pressure therapy with AFLEX
Auto AFlex: Positive pressure therapy treatment
|
Auto CPAP
n=53 Participants
auto adjusting positive pressure therapy
Auto CPAP: Positive pressure therapy treatment
|
CPAP
n=57 Participants
continuous positive airway pressure
CPAP: Positive pressure therapy treatment
|
|---|---|---|---|
|
Apnea-Hypopnea Index
Baseline
|
6.09 events/hour
Standard Deviation 7.20
|
3.54 events/hour
Standard Deviation 4.39
|
3.24 events/hour
Standard Deviation 3.46
|
|
Apnea-Hypopnea Index
180 Days
|
1.26 events/hour
Standard Deviation 2.92
|
0.67 events/hour
Standard Deviation 0.93
|
1.04 events/hour
Standard Deviation 1.28
|
SECONDARY outcome
Timeframe: 180 daysPopulation: During the course of the study 24 participants withdrew from the study.
The average hours of nightly use is the average number of hours the participant used there device overnight at home during the study.
Outcome measures
| Measure |
Auto Aflex
n=46 Participants
auto adjusting positive pressure therapy with AFLEX
Auto AFlex: Positive pressure therapy treatment
|
Auto CPAP
n=47 Participants
auto adjusting positive pressure therapy
Auto CPAP: Positive pressure therapy treatment
|
CPAP
n=47 Participants
continuous positive airway pressure
CPAP: Positive pressure therapy treatment
|
|---|---|---|---|
|
Average Hours of Nightly Use.
|
4.44 hours
Standard Deviation 1.98
|
4.63 hours
Standard Deviation 1.75
|
4.40 hours
Standard Deviation 2.02
|
SECONDARY outcome
Timeframe: Baseline and 180 DaysPopulation: During the course of the study 24 participants withdrew from the study.
Psychomotor Vigilance Task-PVT is a 10-min attention/vigilance test. To measure trends of vigilance after 180 days of home use randomized sleep apnea trial. This measured how quickly participants reacted to visual stimulus and counted number of lapses. Lapses (errors of omission) are measured or usually defined as reaction Times ≥ 500 ms.
Outcome measures
| Measure |
Auto Aflex
n=54 Participants
auto adjusting positive pressure therapy with AFLEX
Auto AFlex: Positive pressure therapy treatment
|
Auto CPAP
n=53 Participants
auto adjusting positive pressure therapy
Auto CPAP: Positive pressure therapy treatment
|
CPAP
n=57 Participants
continuous positive airway pressure
CPAP: Positive pressure therapy treatment
|
|---|---|---|---|
|
Psychomotor Vigilance Task - Number of Lapses
Baseline
|
2.15 number of lapses
Standard Deviation 3.74
|
3.41 number of lapses
Standard Deviation 7.75
|
2.15 number of lapses
Standard Deviation 4.10
|
|
Psychomotor Vigilance Task - Number of Lapses
180 days
|
0.98 number of lapses
Standard Deviation 2.14
|
0.96 number of lapses
Standard Deviation 1.32
|
1.30 number of lapses
Standard Deviation 3.32
|
SECONDARY outcome
Timeframe: Baseline and 180 DaysPopulation: During the course of the study 24 participants withdrew from the study.
FOSQ is a quality of life questionnaire for sleep disorders. It's a 30 question survey with 5 subgroups: general productivity (8 questions), social outcome (2 questions),activity level (9 questions), vigilance (7 questions) and intimate relationships \& sexual activity (4 questions). Scores are provided on a 0 to 4 scale: 0- I don't do this activity for other reasons or missing response 1- Yes, extreme difficulty 4- no difficulty The average score was calculated based upon average sub-scores. The total score was,calculated using the mean of the subscale scores and multiplying the mean by the number of subscales. The range of scores for the total score is 5-20. The measures are designed to assess the impact of disorders of excessive sleepiness on activities of everyday living and the extent to which these abilities are improved by effective treatment. The lower the score the more difficulty a person has carrying out certain activities because they are too sleepy or tired.
Outcome measures
| Measure |
Auto Aflex
n=54 Participants
auto adjusting positive pressure therapy with AFLEX
Auto AFlex: Positive pressure therapy treatment
|
Auto CPAP
n=53 Participants
auto adjusting positive pressure therapy
Auto CPAP: Positive pressure therapy treatment
|
CPAP
n=57 Participants
continuous positive airway pressure
CPAP: Positive pressure therapy treatment
|
|---|---|---|---|
|
Functional Outcomes of Sleep Questionnaire (FOSQ)
baseline
|
15.17 score on a scale
Standard Deviation 3.13
|
15.85 score on a scale
Standard Deviation 2.94
|
14.57 score on a scale
Standard Deviation 3.97
|
|
Functional Outcomes of Sleep Questionnaire (FOSQ)
180 days
|
17.11 score on a scale
Standard Deviation 2.22
|
17.78 score on a scale
Standard Deviation 2.06
|
16.74 score on a scale
Standard Deviation 3.26
|
SECONDARY outcome
Timeframe: Baseline and 180 DaysPopulation: During the course of the study 24 participants withdrew from the study.
Attitudes Toward Use Questionnaire (ATUQ) a self-efficacy scale based on psychological theories of behavior change and modified from one developed by Stepnowsky and Marler this outcome focused on confidence, expectations and importance. Confidence is a 5 question survey, it is measured on a scale of 1 to 5 1- disagree completely and 5 being agree completely. The scores range from 5 to 25 with 25 being extremely confident. Importance is a 11 question survey, it is measured on a scale of 1 to 5 1- disagree completely and 5 being agree completely. The importance ATU was combined with Exceptions survey, which is 4 questions. The expectations survey is measured on a scale of 1 to 5, with 1 being not at all effective and 5 extremely effective. The scores range from 15 to 75 with 75 being extremely important/ extremely effective.
Outcome measures
| Measure |
Auto Aflex
n=54 Participants
auto adjusting positive pressure therapy with AFLEX
Auto AFlex: Positive pressure therapy treatment
|
Auto CPAP
n=53 Participants
auto adjusting positive pressure therapy
Auto CPAP: Positive pressure therapy treatment
|
CPAP
n=57 Participants
continuous positive airway pressure
CPAP: Positive pressure therapy treatment
|
|---|---|---|---|
|
Attitudes Toward Use
Confidence at baseline
|
20.7 units on a scale
Standard Deviation 3.6
|
21.8 units on a scale
Standard Deviation 2.9
|
22.3 units on a scale
Standard Deviation 2.6
|
|
Attitudes Toward Use
Confidence at 180 days
|
20.7 units on a scale
Standard Deviation 5.2
|
22.5 units on a scale
Standard Deviation 3.3
|
21.9 units on a scale
Standard Deviation 4.1
|
|
Attitudes Toward Use
Expectations + Importance at baseline
|
49.8 units on a scale
Standard Deviation 7.4
|
48.4 units on a scale
Standard Deviation 5.0
|
48.1 units on a scale
Standard Deviation 6.9
|
|
Attitudes Toward Use
Expectations + Importance at 180 days
|
47.2 units on a scale
Standard Deviation 5.3
|
46.7 units on a scale
Standard Deviation 5.8
|
46.9 units on a scale
Standard Deviation 5.0
|
SECONDARY outcome
Timeframe: 30, 90, and 180 daysPopulation: During the course of the study 24 participants withdrew from the study.
visual analog scales where used to assess the question "in the last month how do you rate the overall comfort of the mask"? 0 = very uncomfortable to 100 = very comfortable
Outcome measures
| Measure |
Auto Aflex
n=54 Participants
auto adjusting positive pressure therapy with AFLEX
Auto AFlex: Positive pressure therapy treatment
|
Auto CPAP
n=53 Participants
auto adjusting positive pressure therapy
Auto CPAP: Positive pressure therapy treatment
|
CPAP
n=57 Participants
continuous positive airway pressure
CPAP: Positive pressure therapy treatment
|
|---|---|---|---|
|
Subjective Assessment of Therapy Comfort.
30 days
|
50.8 units on a scale
Standard Deviation 21.5
|
57.9 units on a scale
Standard Deviation 20.5
|
53.9 units on a scale
Standard Deviation 18.9
|
|
Subjective Assessment of Therapy Comfort.
90 days
|
53.8 units on a scale
Standard Deviation 25.1
|
61.0 units on a scale
Standard Deviation 15.0
|
59.2 units on a scale
Standard Deviation 18.3
|
|
Subjective Assessment of Therapy Comfort.
180 days
|
54.7 units on a scale
Standard Deviation 21.7
|
60.1 units on a scale
Standard Deviation 14.7
|
60.6 units on a scale
Standard Deviation 17.9
|
SECONDARY outcome
Timeframe: Baseline and 180 daysPopulation: During the course of the study 24 participants withdrew from the study.
Epworth Sleepiness Scale is a test that measures sleepiness during daily life activities. This is an 8 question survey. Scores are provided on a 0 to 3 scale: 0 = no chance of dozing 1. = slight chance of dozing 2. = moderate chance of dozing 3. = high chance of dozing Scores range from 0 to 24. The higher the total number, the higher the overall sleepiness.
Outcome measures
| Measure |
Auto Aflex
n=54 Participants
auto adjusting positive pressure therapy with AFLEX
Auto AFlex: Positive pressure therapy treatment
|
Auto CPAP
n=53 Participants
auto adjusting positive pressure therapy
Auto CPAP: Positive pressure therapy treatment
|
CPAP
n=57 Participants
continuous positive airway pressure
CPAP: Positive pressure therapy treatment
|
|---|---|---|---|
|
Epworth Sleepiness Scale
Baseline
|
10.43 units on a scale
Standard Deviation 5.25
|
10.49 units on a scale
Standard Deviation 4.59
|
12.27 units on a scale
Standard Deviation 5.94
|
|
Epworth Sleepiness Scale
180 Days
|
6.93 units on a scale
Standard Deviation 4.30
|
7.02 units on a scale
Standard Deviation 4.66
|
7.87 units on a scale
Standard Deviation 5.53
|
Adverse Events
Auto Aflex
Auto CPAP
CPAP
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Clete A. Kushida, MD, PhD
Stanford Sleep Medicine Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place