Trial Outcomes & Findings for Evaluation of Adherence and Therapeutic Effectiveness of Bi-Flex Versus CPAP in Children With OSA (NCT NCT00458406)
NCT ID: NCT00458406
Last Updated: 2019-10-02
Results Overview
The number of minutes of use per night at month 1.
COMPLETED
NA
60 participants
1 month
2019-10-02
Participant Flow
N=60 families were enrolled; N=4 of these were excluded due to various medical conditions. Of the remaining N=56, N=43 were enrolled into the Bi-Flex arm and N=13 were enrolled into the CPAP arm.
Sixty-nine consecutive families were approached for the study. Nine families declined the study. N=60 families were enrolled; N=4 of these were excluded due to various medical conditions. Of the remaining N=56, N=43 were enrolled into the Bi-Flex arm and N=13 were enrolled into the CPAP arm.
Participant milestones
| Measure |
Bi-Flex
Subjects randomized to this arm will undergo a clinical Bi-Flex sleep study. Subjects in this arm underwent bilevel positive airway pressure with pressure release technology (Bi-Flex) therapy. In this randomized, double-blinded clinical trial, patients with obstructive sleep apnea were randomized Bi-Flex or CPAP, and a repeat polysomnography was performed on pressure at 3 months.
Of the N=56 assessed subjects, N=43 were enrolled into the Bi-Flex arm.
|
CPAP
Subjects randomized to this arm will undergo a clinical CPAP titration sleep study.
Subjects in this arm underwent standard continuous positive airway pressure (CPAP) therapy.
In this randomized, double-blinded clinical trial, patients with obstructive sleep apnea were randomized Bi-Flex or CPAP, and a repeat polysomnography was performed on pressure at 3 months.
Of the N=56 assessed subjects, N=13 were enrolled into the CPAP arm.
|
|---|---|---|
|
Month 1
STARTED
|
43
|
13
|
|
Month 1
COMPLETED
|
43
|
13
|
|
Month 1
NOT COMPLETED
|
0
|
0
|
|
Month 3
STARTED
|
43
|
13
|
|
Month 3
COMPLETED
|
43
|
13
|
|
Month 3
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of Adherence and Therapeutic Effectiveness of Bi-Flex Versus CPAP in Children With OSA
Baseline characteristics by cohort
| Measure |
Bi-Flex
n=43 Participants
Subjects randomized to this arm will undergo a clinical Bi-Flex sleep study.
|
CPAP
n=13 Participants
Subjects randomized to this arm will undergo a clinical CPAP titration sleep study.
|
Total
n=56 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
43 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
12 years
STANDARD_DEVIATION 4 • n=5 Participants
|
12 years
STANDARD_DEVIATION 4 • n=7 Participants
|
12 years
STANDARD_DEVIATION 4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
43 participants
n=5 Participants
|
13 participants
n=7 Participants
|
56 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 monthPopulation: The study sample size of 45 in the Bi-Flex group and 15 in the CPAP group had 80% power to detect an effect size ≥ 0.85 with a 0.05 two-sided significance level. In addition, with this sample size, the 95% CI for the difference between the 2 means had a range of 1.282 SD.
The number of minutes of use per night at month 1.
Outcome measures
| Measure |
Bi-Flex
n=43 Participants
Subjects in this arm underwent bilevel positive airway pressure with pressure release technology (Bi-Flex) therapy.
|
CPAP
n=13 Participants
Subjects in this arm underwent standard continuous positive airway pressure (CPAP) therapy.
|
|---|---|---|
|
Minutes of Use Per Night at Month 1
|
185 minutes
Standard Deviation 165
|
201 minutes
Standard Deviation 135
|
PRIMARY outcome
Timeframe: 3 MonthsPopulation: The study sample size of 45 in the Bi-Flex group and 15 in the CPAP group had 80% power to detect an effect size ≥ 0.85 with a 0.05 two-sided significance level. In addition, with this sample size, the 95% CI for the difference between the 2 means had a range of 1.282 SD.
The number of minutes of use per night at Month 3.
Outcome measures
| Measure |
Bi-Flex
n=43 Participants
Subjects in this arm underwent bilevel positive airway pressure with pressure release technology (Bi-Flex) therapy.
|
CPAP
n=13 Participants
Subjects in this arm underwent standard continuous positive airway pressure (CPAP) therapy.
|
|---|---|---|
|
Minutes of Use Per Night at Month 3
|
183 minutes
Standard Deviation 169
|
125 minutes
Standard Deviation 165
|
PRIMARY outcome
Timeframe: month 1, month 3minutes of use per night at Month 3 minus minutes of use per night at Month 1
Outcome measures
| Measure |
Bi-Flex
n=43 Participants
Subjects in this arm underwent bilevel positive airway pressure with pressure release technology (Bi-Flex) therapy.
|
CPAP
n=13 Participants
Subjects in this arm underwent standard continuous positive airway pressure (CPAP) therapy.
|
|---|---|---|
|
Change in Minutes of Use Per Night From Month 1 to Month 3
|
-11.1 minutes
Standard Deviation 130.6
|
-76.2 minutes
Standard Deviation 116.6
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Power calculation: The study sample size of 45 in the Bi-Flex group and 15 in the CPAP group had 80% power to detect an effect size ≥ 0.85 with a 0.05 two-sided significance level. In addition, with this sample size, the 95% CI for the difference between the 2 means had a range of 1.282 SD.
Number of drop-outs included subjects in which investigators were unable to obtain a final download from the device.
Outcome measures
| Measure |
Bi-Flex
n=43 Participants
Subjects in this arm underwent bilevel positive airway pressure with pressure release technology (Bi-Flex) therapy.
|
CPAP
n=13 Participants
Subjects in this arm underwent standard continuous positive airway pressure (CPAP) therapy.
|
|---|---|---|
|
Drop Out Rate
|
1 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: The study sample size of 45 in the Bi-Flex group and 15 in the CPAP group had 80% power to detect an effect size ≥ 0.85 with a 0.05 two-sided significance level. In addition, with this sample size, the 95% CI for the difference between the 2 means had a range of 1.282 SD.
Change in Apnea Hypopnea Index from Month 1 to Month 3. AHI at Month 3 minus AHI at Month 1.
Outcome measures
| Measure |
Bi-Flex
n=43 Participants
Subjects in this arm underwent bilevel positive airway pressure with pressure release technology (Bi-Flex) therapy.
|
CPAP
n=13 Participants
Subjects in this arm underwent standard continuous positive airway pressure (CPAP) therapy.
|
|---|---|---|
|
Change in Apnea Hypopnea Index (AHI; Number of Apneas and Hypopneas Per Hour of Sleep) From Month 1 to Month 3
|
-8.8 Apneas and Hypopneas/hr sleep
Interval -62.1 to 5.1
|
-13.7 Apneas and Hypopneas/hr sleep
Interval -42.8 to 6.4
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: The data for BiFlex and CPAP arms are not available for this Outcome Measure since the original PI for the study is deceased. Limited data are available for the study results
Polysomnographic measurements of sleep quality using the OSA 18 score at 3 months
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 monthsChange in the Epworth Sleepiness Scale (ESS) score from Month 1 to Month 3: (Score at Month 3 minus Score at Month 1). The ESS measures daytime sleepiness in certain situations e.g. sitting/reading, watching television, sitting inactive in public, as a passenger in a car for an hour without a break, lying down to rest in the afternoon when circumstances permit, sitting/talking with someone, sitting quietly after lunch, or in a car, while stopped for a few minutes in traffic. The scale ranges from a minimum of zero to 24, with higher scores indicating greater daytime sleepiness.
Outcome measures
| Measure |
Bi-Flex
n=43 Participants
Subjects in this arm underwent bilevel positive airway pressure with pressure release technology (Bi-Flex) therapy.
|
CPAP
n=13 Participants
Subjects in this arm underwent standard continuous positive airway pressure (CPAP) therapy.
|
|---|---|---|
|
Change in ESS From Month 1 to Month 3
|
-4.5 units on a scale
Standard Deviation 4.0
|
-2.3 units on a scale
Standard Deviation 4.8
|
SECONDARY outcome
Timeframe: 3 monthsChange in the total Nasal Obstruction Symptom Evaluation (NOSE) scale score (Score at Month 3 minus Score at Month 1). This scale evaluates the severity of nasal obstructive symptoms. The scale ranges from 0-20, with a higher score indicating more nasal obstruction.
Outcome measures
| Measure |
Bi-Flex
n=43 Participants
Subjects in this arm underwent bilevel positive airway pressure with pressure release technology (Bi-Flex) therapy.
|
CPAP
n=13 Participants
Subjects in this arm underwent standard continuous positive airway pressure (CPAP) therapy.
|
|---|---|---|
|
Change in NOSE Scale Score From Month 1 to Month 3
|
-1.6 units on a scale
Standard Deviation 6.8
|
-5.7 units on a scale
Standard Deviation 5.9
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: The data for BiFlex and CPAP arms are not available for this Outcome Measure since the original PI for the study is deceased. Limited data are available for the study results
Change in quality of life from baseline to 3 months
Outcome measures
Outcome data not reported
Adverse Events
Bi-Flex
CPAP
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Paul R. Gallagher, MA
CTRC, Children's Hospital of Philadelphia
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place