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NCT04928157 · ClinicalTrials.gov registry record · Phase 2
Prospective Randomized Trial of CPAP for SDB in Patients Who Use Opioids
A Phase 2 study, sponsored by University of California, San Diego.
- Completed
- Registry status
- Phase 2
- Development phase
- 62
- Enrollment target
NCT04928157: Completed Phase 2 study, sponsored by University of California, San Diego.
NCT04928157 is a Phase 2 study that has completed, run by University of California, San Diego. The registered enrollment target is 62 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04928157, a Phase 2 study, has completed, sponsored by University of California, San Diego.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 62 participants
- Enrollment target
Study Summary
Patients with chronic pain who use opioids appear to be at increased risk for breathing issues during sleep, termed sleep disordered breathing (SDB). Treatment of SDB often consists of use of a device during sleep that provides continuous positive airway pressure (CPAP) via a mask interface. The goal of this study is to determine whether patients with chronic pain who use opioids and have SDB might benefit from the use of CPAP in terms of sleep quality, pain, quality of life, and other measures. In addition, the study will examine whether these individuals are able to adhere to CPAP, which will be important for future studies. Lastly, we anticipate that CPAP won't work for everyone due to the changes that opioids can cause in breathing patterns. We will examine how often CPAP is ineffective, and whether we can predict which individuals are least likely to resolve their SDB with CPAP.
Primary Outcome
A questionnaire to assess self-reported quality of general sleep and sleep disturbance. Each item on the form is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of sleep disturbance.
Interventions
- DEVICE Positive Airway Pressure (PAP)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2021-08-10 |
| Est. Completion | 2024-09-12 |
| Phase | Phase 2 |
What the finished NCT04928157 record still lists
NCT04928157 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 62 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (53% lower).
The record links to 0 conditions, and to 1 intervention - of which Positive Airway Pressure (PAP) is the first listed.
NCT04928157 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04928157 about?
NCT04928157 is a clinical study titled "Prospective Randomized Trial of CPAP for SDB in Patients Who Use Opioids". Patients with chronic pain who use opioids appear to be at increased risk for breathing issues during sleep, termed sleep disordered breathing (SDB). Treatment of SDB often consists of use of a device during sleep that provides continuous positive airway pressure (CPAP) via a mask interface. The goa...
What is the current status of trial NCT04928157?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 62 participants. The study started on 2021-08-10. Estimated completion is 2024-09-12.
What interventions are being tested in trial NCT04928157?
The interventions under investigation include: Positive Airway Pressure (PAP) (DEVICE).
Who is sponsoring clinical trial NCT04928157?
This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04928157's enrollment target sits among peer trials
62 1016th of 2000 higher than 975 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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