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NCT00458406 · ClinicalTrials.gov registry record · NA
Evaluation of Adherence and Therapeutic Effectiveness of Bi-Flex Versus CPAP in Children With OSA
A NA study, sponsored by Children's Hospital of Philadelphia.
- Completed
- Registry status
- NA
- Development phase
- 60
- Enrollment target
NCT00458406: Completed NA study, sponsored by Children's Hospital of Philadelphia.
NCT00458406 is a NA study that has completed, run by Children's Hospital of Philadelphia. The registered enrollment target is 60 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00458406, a NA study, has completed, sponsored by Children's Hospital of Philadelphia.
- COMPLETED
- Registry status
- NA
- Development phase
- 60 participants
- Enrollment target
Study 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. .
Primary Outcome
The number of minutes of use per night at month 1.
Interventions
- DEVICE CPAP
- DEVICE Bi-Flex
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2007-05 |
| Est. Completion | 2012-04 |
| Phase | NA |
What the finished NCT00458406 record still lists
NCT00458406 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which CPAP is the first listed.
NCT00458406 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00458406 about?
NCT00458406 is a clinical study titled "Evaluation of Adherence and Therapeutic Effectiveness of Bi-Flex Versus CPAP in Children With OSA". 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 ...
What is the current status of trial NCT00458406?
This trial is currently completed. It is a NA study. The enrollment target is 60 participants. The study started on 2007-05. Estimated completion is 2012-04.
What interventions are being tested in trial NCT00458406?
The interventions under investigation include: CPAP (DEVICE), Bi-Flex (DEVICE).
Who is sponsoring clinical trial NCT00458406?
This trial is sponsored by Children's Hospital of Philadelphia, which has 431 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00458406's enrollment target sits among peer trials
60 1164th of 2000 higher than 745 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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