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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 is a Phase 3 study that has completed, run by Clayton Sleep Insititute. The registered enrollment target is 51 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00635206
The ClinicalTrials.gov registry entry for NCT00635206 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 51 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Clayton Sleep Insititute, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Standard CPAP is the first listed.
NCT00635206 reports 0 study locations.
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.
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