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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 is a NA study that has completed, run by Children's Hospital of Philadelphia. The registered enrollment target is 60 participants.
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. .
Interventions
- DEVICE CPAP
- DEVICE Bi-Flex
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2007-05 |
| Est. Completion | 2012-04 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00458406
The ClinicalTrials.gov registry entry for NCT00458406 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's Hospital of Philadelphia, which has 431 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which CPAP is the first listed.
NCT00458406 reports 0 study locations.
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.
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