N/A
N=56
Evaluation of Adherence and Therapeutic Effectiveness of Bi-Flex Versus CPAP in Children With OSA
Obstructive Sleep Apnea
Bottom Line
View on ClinicalTrials.gov: NCT00458406 ↗Enrolled (actual)
56
Serious AEs
0.0%
Results posted
Apr 2014
Primary outcome: Primary: Minutes of Use Per Night at Month 1 — 185; 201 minutes — p=0.512
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Bi-Flex (Device); CPAP (Device)
- Age
- Pediatric · 2+ yrs
- Sex
- All
- Sponsor
- Children's Hospital of Philadelphia
- Primary completion
- Apr 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Minutes of Use Per Night at Month 1 |
185; 201 | 0.512 |
| PRIMARY Minutes of Use Per Night at Month 3 |
183; 125 | >0.05 |
| PRIMARY Change in Minutes of Use Per Night From Month 1 to Month 3 |
-11.1; -76.2 | >0.05 |
| SECONDARY Drop Out Rate |
1; 1 | >0.05 |
| SECONDARY Change in Apnea Hypopnea Index (AHI; Number of Apneas and Hypopneas Per Hour of Sleep) From Month 1 to Month 3 |
-8.8; -13.7 | >0.05 |
| SECONDARY Obstructive Sleep Apnea (OSA) 18 Score |
— | — |
| SECONDARY Change in ESS From Month 1 to Month 3 |
-4.5; -2.3 | >0.05 |
| SECONDARY Change in NOSE Scale Score From Month 1 to Month 3 |
-1.6; -5.7 | >0.05 |
| SECONDARY Pediatric Quality of Life (PedQL) |
— | — |
Summary
Context: The obstructive sleep apnea syndrome (OSAS), i.e., snoring with difficulty breathing during sleep, is common in children. Continuous positive airway pressure (CPAP) therapy is the usual treatment for children who do not improve following surgery. However, CPAP is uncomfortable and is often not tolerated. We therefore plan to study a modification of bilevel positive airway pressure therapy, BiPAP with Bi-Flex that may be more comfortable.
Objectives: The primary objective of this study is to determine whether BiPAP with Bi-Flex results in improvement in adherence as compared to CPAP. The secondary objective is to determine whether Bi-Flex has similar therapeutic efficacy compared to CPAP, as determined by sleep study. Additional objectives include comparing CPAP and Bi-Flex effects on comfort and determining which parameters predict adherence.
Study Design/Setting/Participants: A single center, randomized controlled double-blind study of Bi-Flex vs CPAP use in children with OSAS over a 3 month period.
Intervention: Bi-Flex vs CPAP Study Measures: Objective compliance recordings, sleep study results, subjective questionnaire results. .
Eligibility Criteria
Inclusion Criteria
- Males or females aged 2 to 16 years.
- OSAS diagnosed on polysomnography.
- Positive airway pressure therapy indicated by patient's physician because surgery was either contraindicated or ineffective.
- No plans for upper airway surgery in the next 3 months.
Exclusion Criteria
- Age less than 2 years, as infants and toddlers have different pulmonary mechanics from older children, and may require intense behavioral modification programs prior to CPAP use.
- Age greater or equal to 16 years, as results may be similar to adult studies in these older patients.
- Previous use of CPAP / bilevel ventilation.
- Unable to read / understand English. -
Data sourced from ClinicalTrials.gov (NCT00458406). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.