At a glance
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Evaluation of Adherence and Therapeutic Effectiveness of BiPAP With Bi-Flex Versus CPAP in Children With Obstructive Sleep Apnea
In Brief
A clinical study evaluating Bi-Flex and CPAP for Obstructive Sleep Apnea. Completed, enrolled 60 participants across 1 site.
Detailed 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. .
Study Details
Timeline
Interventions
Bi-Flex: Subjects in this arm undergo bilevel positive airway pressure with pressure release technology (Bi-Flex) therapy. Positive pressure used during sleep for 3 months
CPAP: Subjects in this arm undergo standard continuous positive airway pressure (CPAP) therapy. Positive pressure used during sleep for 3 months.