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NCT04928157: PRESTO
Prospective Randomized Trial of CPAP for SDB in Patients Who Use Opioids
Phase 2 trial testing Positive Airway Pressure (PAP) in Sleep Disorder; Breathing-Related in 62 participants. Completed in 12 September 2024.
12 September 2024
Quick facts
| Lead sponsor | University of California, San Diego |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 62 |
| Start date | 10 August 2021 |
| Primary completion | 12 September 2024 |
| Estimated completion | 12 September 2024 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Positive Airway Pressure (PAP)
Conditions studied
- Sleep Disorder; Breathing-Related — all drugs for Sleep Disorder; Breathing-Related →
- Pain — all drugs for Pain →
- Sleep Apnea — all drugs for Sleep Apnea →
- Obstructive Sleep Apnea — all drugs for Obstructive Sleep Apnea →
Sponsor
University of California, San Diego
Who can join
18 and older, any sex, with Sleep Disorder; Breathing-Related or Pain. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04928157
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Positive Airway Pressure (PAP)
Trials testing the same drug.
- NCT02784977 — TURKAPNE - The Turkish Sleep Apnea Database: A National, Multicenter, Observational, Prospective Cohort Study · recruiting
Other recruiting trials for Sleep Disorder; Breathing-Related
Currently open trials in the same condition.
- NCT03478566 — Transcutaneous CO2 Monitoring at Home for Children With Neuromuscular Disease · NA · active not recruiting
Other University of California, San Diego trials
Trials by the same sponsor.
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- NCT07211802 — CKM For Safe Use of SGLT2i in Type 1 Diabetes · Phase 3 · not yet recruiting
- NCT07524751 — Culturally Adapted Pain Management for Indigenous Peoples · NA · not yet recruiting
- NCT07518784 — Accurate Point of Care Liver Disease Diagnostics (Phase 2) · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04928157 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of California, San Diego
- Last refreshed: 2 December 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04928157.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing