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NCT01335854 · ClinicalTrials.gov registry record · Early Phase 1
Promoting Continuous Positive Airway Pressure (CPAP) Adherence
A Early Phase 1 study of Obstructive Sleep Apnea, sponsored by University of Pennsylvania.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 135
- Enrollment target
- 2
- Study locations
NCT01335854: Completed Early Phase 1 study of Obstructive Sleep Apnea, sponsored by University of Pennsylvania.
NCT01335854 is a Early Phase 1 study of Obstructive Sleep Apnea that has completed, run by University of Pennsylvania. The registered enrollment target is 135 participants, below the 221-participant average among 155 other Obstructive Sleep Apnea trials with a reported enrollment target (39% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01335854, a Early Phase 1 study of Obstructive Sleep Apnea, has completed, sponsored by University of Pennsylvania.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 135 participants
- Enrollment target
- 2
- Study locations
Study Summary
The proposed research will evaluate new approaches to improving the ability of patients with obstructive sleep apnea (OSA), a breathing disorder during sleep, to use continuous positive airway pressure (CPAP), a medical device worn during sleep to treat OSA. 120 patients with newly diagnosed OSA who are being initiated on CPAP treatment will be assigned to one of 3 groups: usual care, usual care with web-based access to daily CPAP adherence, and usual care with web-based access to daily CPAP adherence and a financial incentive to use CPAP at least 4 hours/day in the first week of treatment. Measures of CPAP use, daytime sleepiness, and quality of life will evaluate whether patients provided web-based access to their daily CPAP adherence with and without financial incentive will have greater objectively measured average daily hours of CPAP use and greater improvement in functional outcomes following 3 months of treatment compared to patients receiving usual care. The results will test the hypothesis that these behavioral interventions will improve patient adherence to CPAP during the critically important first week of treatment when many patients are deciding whether or not to use CPAP and that this initial level of adherence will be maintained over the long term despite withdrawal of the financial incentive.
Primary Outcome
Average daily hours of CPAP use determined objectively by the mask-on time recorded by the CPAP machine.
Conditions Studied
Interventions
- BEHAVIORAL Web-based Access to CPAP Data
- BEHAVIORAL Web-based Access to CPAP Data with Financial Incentive
Study Locations (2)
Pennsylvania
- Hospital of the University of Pennsylvania - Philadelphia
- Lankenau Medical Center - Wynnewood
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 135 participants |
| Start Date | 2011-09 |
| Est. Completion | 2013-08 |
| Phase | Early Phase 1 |
What the finished NCT01335854 record still lists
NCT01335854 is an interventional study that assigns participants to a tested intervention. The registered 135 participants enrollment target is mid-sized for trials with a published cap, below the 221-participant average among 155 other Obstructive Sleep Apnea trials with a reported enrollment target (39% lower).
The record links to 1 condition, with Obstructive Sleep Apnea appearing as the primary indexed condition, and to 2 interventions - of which Web-based Access to CPAP Data is the first listed.
NCT01335854 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT01335854 about?
NCT01335854 is a clinical study titled "Promoting Continuous Positive Airway Pressure (CPAP) Adherence". The proposed research will evaluate new approaches to improving the ability of patients with obstructive sleep apnea (OSA), a breathing disorder during sleep, to use continuous positive airway pressure (CPAP), a medical device worn during sleep to treat OSA. 120 patients with newly diagnosed OSA who...
What is the current status of trial NCT01335854?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 135 participants. The study started on 2011-09. Estimated completion is 2013-08.
What conditions does trial NCT01335854 study?
This clinical trial studies the following conditions: Obstructive Sleep Apnea.
What interventions are being tested in trial NCT01335854?
The interventions under investigation include: Web-based Access to CPAP Data (BEHAVIORAL), Web-based Access to CPAP Data with Financial Incentive (BEHAVIORAL).
Who is sponsoring clinical trial NCT01335854?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01335854 being conducted?
This trial has 2 study locations across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Obstructive Sleep Apnea
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01335854's enrollment target sits among peer trials
135 54th of 155 higher than 102 of 155 other Obstructive Sleep Apnea trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Obstructive Sleep Apnea 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.
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