Evaluation of Adherence and Therapeutic Effectiveness of Bi-Flex Versus CPAP in Children With OSA

Completed · Not applicable

Conditions studied: Obstructive Sleep Apnea

In brief

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. .

Key facts

Study ID

NCT00458406

Run by

Children's Hospital of Philadelphia

People needed

60

Starts

2007-05-01

Expected to finish

2012-04-01

Last updated by the study team

2019-10-02

Who can join

Age: 2 and older, up to 16. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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. -

Where it is running

• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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