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NCT00635206 · ClinicalTrials.gov registry record · Phase 3
Investigation of a Novel Positive Pressure Therapy to Rescue Patients Failing to Tolerate CPAP During an Initial Encounter
A Phase 3 study, sponsored by Clayton Sleep Insititute.
- Completed
- Registry status
- Phase 3
- Development phase
- 51
- Enrollment target
NCT00635206: Completed Phase 3 study, sponsored by Clayton Sleep Insititute.
NCT00635206 is a Phase 3 study that has completed, run by Clayton Sleep Insititute. The registered enrollment target is 51 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00635206, a Phase 3 study, has completed, sponsored by Clayton Sleep Insititute.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 51 participants
- Enrollment target
Study Summary
The primary objective outcome is the proportion of participants compliant (at least four hours of use per night for all nights) in the Auto Bilevel group compared to the CPAP group after 90 days of treatment during the investigation. Proportion will be calculated using the cumulative number of hours on therapy divided by the total number of days of the investigation for each participant. The mean and standard deviation of these mean therapy hours will then be calculated for each arm of the investigation. Participants with compliance of at least four hours will be classified as "compliant" and those with less than four hours will be classified as "non-compliant". The null hypothesis will be rejected if the mean of the primary objective outcome for all participants in the BiPAP® Auto with Bi-Flex® therapy arm is significantly greater than that for all participants in the CPAP therapy arm. Secondary Measures The secondary measures used to evaluate potentially improved adherence to BiPAP® Auto with Bi-Flex® therapy compared to CPAP therapy will include: * Hours of use per night, for all nights * Hours of use per night, for nights with therapy use * Device derived AHI * Heart Rate Variability * Functional Outcomes of Sleep Questionnaire (FOSQ), * 10 cm Visual Analog Scale (VAS) for mask comfort and satisfaction with therapy, * Epworth Sleepiness Scale (ESS) questionnaire * Psychomotor Vigilance Task * Attitudes toward use * Actigraphy (sleep continuity) and sleep diary * Fatigue Severity Scale * Daytime Functioning Scale
Interventions
- DEVICE Standard CPAP
- DEVICE BiPap auto with Fi Flex
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2007-09 |
| Est. Completion | 2009-05 |
| Phase | Phase 3 |
What the finished NCT00635206 record still lists
NCT00635206 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 2 interventions - of which Standard CPAP is the first listed.
NCT00635206 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00635206 about?
NCT00635206 is a clinical study titled "Investigation of a Novel Positive Pressure Therapy to Rescue Patients Failing to Tolerate CPAP During an Initial Encounter". The primary objective outcome is the proportion of participants compliant (at least four hours of use per night for all nights) in the Auto Bilevel group compared to the CPAP group after 90 days of treatment during the investigation. Proportion will be calculated using the cumulative number of hours...
What is the current status of trial NCT00635206?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 51 participants. The study started on 2007-09. Estimated completion is 2009-05.
What interventions are being tested in trial NCT00635206?
The interventions under investigation include: Standard CPAP (DEVICE), BiPap auto with Fi Flex (DEVICE).
Who is sponsoring clinical trial NCT00635206?
This trial is sponsored by Clayton Sleep Insititute, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00635206's enrollment target sits among peer trials
51 1842nd of 2000 higher than 157 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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