Trial Outcomes & Findings for Auto Bilevel Adherence Following a Poor Initial Encounter With Continuous Positive Airway Pressure (CPAP) (NCT NCT02522442)
NCT ID: NCT02522442
Last Updated: 2019-04-26
Results Overview
Compliance was compared between the AutoBiLevel Group and the CPAP group by measuring the average use per night over the study period.
COMPLETED
NA
51 participants
90 days
2019-04-26
Participant Flow
A total of 51 patients completing clinical polysomnography (PSG) with CPAP was assessed for study eligibility and consented to study participation across 3 study sites.
3 participants aborted their PSG during titration and were not considered for randomization into this trial. They were not included in the baseline demographic analysis.
Participant milestones
| Measure |
Auto BiLevel Group
Auto Bilevel; auto-titrating bilevel positive airway pressure device with pressure flexing used as experimental treatment for obstructive sleep apnea
|
CPAP Group
CPAP; continuous positive airway pressure used as comparator treatment for obstructive sleep apnea
|
|---|---|---|
|
Overall Study
STARTED
|
26
|
22
|
|
Overall Study
COMPLETED
|
26
|
22
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Auto Bilevel Adherence Following a Poor Initial Encounter With Continuous Positive Airway Pressure (CPAP)
Baseline characteristics by cohort
| Measure |
Auto BiLevel Group
n=26 Participants
Auto Bilevel; auto-titrating bilevel positive airway pressure device with pressure flexing used as experimental treatment for obstructive sleep apnea
|
CPAP Group
n=22 Participants
CPAP; continuous positive airway pressure used as comparator treatment for obstructive sleep apnea
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.1 years
STANDARD_DEVIATION 12.5 • n=5 Participants
|
56.6 years
STANDARD_DEVIATION 9.8 • n=7 Participants
|
55.4 years
STANDARD_DEVIATION 11.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
26 participants
n=5 Participants
|
22 participants
n=7 Participants
|
48 participants
n=5 Participants
|
|
College Education Level
|
16 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
BMI
|
34.9 kilograms per meter squared
STANDARD_DEVIATION 6.5 • n=5 Participants
|
31 kilograms per meter squared
STANDARD_DEVIATION 4.4 • n=7 Participants
|
33.0 kilograms per meter squared
STANDARD_DEVIATION 5.9 • n=5 Participants
|
|
Nicotine Use
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Alcohol Use
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
ATU-A, Self-Efficacy
|
20.4 units on a scale
STANDARD_DEVIATION 3.2 • n=5 Participants
|
19 units on a scale
STANDARD_DEVIATION 4.7 • n=7 Participants
|
19.6 units on a scale
STANDARD_DEVIATION 4.0 • n=5 Participants
|
PRIMARY outcome
Timeframe: 90 daysPopulation: One randomized participant discontinued the study early (auto-bilevel Group). One participant in the CPAP group used therapy the first night and failed for the remainder of the study but completed all study visits.
Compliance was compared between the AutoBiLevel Group and the CPAP group by measuring the average use per night over the study period.
Outcome measures
| Measure |
Auto BiLevel Group
n=25 Participants
Auto Bilevel; auto-titrating bilevel positive airway pressure device with pressure flexing used as experimental treatment for obstructive sleep apnea
|
CPAP Group
n=21 Participants
CPAP; continuous positive airway pressure used as comparator treatment for obstructive sleep apnea
|
|---|---|---|
|
Group Compliance of the Auto Bilevel Group Compared to the CPAP Group Measured by Average Nightly Use.
|
284.7 minutes/night
Standard Deviation 110.9
|
255.1 minutes/night
Standard Deviation 116.9
|
PRIMARY outcome
Timeframe: 90 daysPopulation: One randomized participant discontinued the study early (auto-bilevel Group). One participant in the CPAP group used therapy the first night and failed for the remainder of the study but completed all study visits.
Percentage of Group Compliance was compared between AutoBiLevel Group and the CPAP group by measuring proportion of adherent users over the treatment period. Patients with compliance of at least four hours will be classified as "compliant" and those with less than four hours will be classified as "non-compliant". The % of compliant patients will be calculated using the cumulative number of hours on therapy divided by the total number of days of the investigation for each subject.
Outcome measures
| Measure |
Auto BiLevel Group
n=26 Participants
Auto Bilevel; auto-titrating bilevel positive airway pressure device with pressure flexing used as experimental treatment for obstructive sleep apnea
|
CPAP Group
n=22 Participants
CPAP; continuous positive airway pressure used as comparator treatment for obstructive sleep apnea
|
|---|---|---|
|
Percentage of Group Compliance of the Auto Bilevel Group Compared to the CPAP Group
|
62 percentage of compliant users
|
55 percentage of compliant users
|
SECONDARY outcome
Timeframe: Assessed at Baseline, Day 30 and Day 90The Epworth Sleepiness Scale is an 8 item questionnaire that measures the general level of daytime sleepiness. Participants were asked what the chance is they would doze off or fall asleep during different routine daytime situations. The survey answers questions on a scale of 0 to 3- 0 being no chance and 3 being a high chance of dozing. The lowest score possible is a 0 and the highest score possible is a 24.
Outcome measures
| Measure |
Auto BiLevel Group
n=26 Participants
Auto Bilevel; auto-titrating bilevel positive airway pressure device with pressure flexing used as experimental treatment for obstructive sleep apnea
|
CPAP Group
n=22 Participants
CPAP; continuous positive airway pressure used as comparator treatment for obstructive sleep apnea
|
|---|---|---|
|
Epworth Sleepiness Scale
Basline
|
9.7 units on a scale
Standard Deviation 3.9
|
8.2 units on a scale
Standard Deviation 4.6
|
|
Epworth Sleepiness Scale
Day 30
|
8.2 units on a scale
Standard Deviation 3.2
|
6.6 units on a scale
Standard Deviation 4.6
|
|
Epworth Sleepiness Scale
Day 90
|
8.1 units on a scale
Standard Deviation 3.8
|
6.9 units on a scale
Standard Deviation 4.4
|
SECONDARY outcome
Timeframe: Assessed at Baseline, Day 30 and Day 90The Fatigue Severity Scale is a 9-item scale which measures the severity of fatigue and its effect on a person's activities and lifestyle in patients with a variety of disorders. Participants answer questions on a scale of 1-7, 1 being Strongly Disagree and 7 being Strongly Agree. The scores can range from 9-63. The higher the score the higher the fatigue.
Outcome measures
| Measure |
Auto BiLevel Group
n=26 Participants
Auto Bilevel; auto-titrating bilevel positive airway pressure device with pressure flexing used as experimental treatment for obstructive sleep apnea
|
CPAP Group
n=22 Participants
CPAP; continuous positive airway pressure used as comparator treatment for obstructive sleep apnea
|
|---|---|---|
|
Fatigue Severity Scale
90 day
|
3.9 units on a scale
Standard Deviation 0.9
|
3.4 units on a scale
Standard Deviation 1.2
|
|
Fatigue Severity Scale
Baseline
|
4.6 units on a scale
Standard Deviation 1.4
|
3.9 units on a scale
Standard Deviation 1.0
|
|
Fatigue Severity Scale
30 day
|
4.0 units on a scale
Standard Deviation 1.2
|
3.7 units on a scale
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: Assessed at Baseline, Day 30 and Day 90Functional Outcomes of Sleep Quality consists of 30 questions related to the effects of fatigue on daily activities, the instrument was designed to evaluate the respondent's quality of life as it relates to disorders of excessive sleepiness. Five domains of day-to-day life are examined: activity levels, vigilance, intimacy and sexual relationships, productivity, and social outcomes. The participants answer on a scale of 0-4: 0 -I don't do this activity for other reasons,1-Yes, extreme, 2-Yes, moderate, 3-Yes, a little, 4-No. Scores can range 0-120, the lower the score the more tired or sleepy the participant is.
Outcome measures
| Measure |
Auto BiLevel Group
n=26 Participants
Auto Bilevel; auto-titrating bilevel positive airway pressure device with pressure flexing used as experimental treatment for obstructive sleep apnea
|
CPAP Group
n=22 Participants
CPAP; continuous positive airway pressure used as comparator treatment for obstructive sleep apnea
|
|---|---|---|
|
Functional Outcomes of Sleep Quality
Baseline
|
84.0 units on a scale
Standard Deviation 20.9
|
91.4 units on a scale
Standard Deviation 17.3
|
|
Functional Outcomes of Sleep Quality
30 day
|
97.5 units on a scale
Standard Deviation 13.8
|
96.6 units on a scale
Standard Deviation 16.6
|
|
Functional Outcomes of Sleep Quality
90 day
|
100.0 units on a scale
Standard Deviation 11.3
|
100.1 units on a scale
Standard Deviation 15.4
|
Adverse Events
Auto BiLevel Group
CPAP Group
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