Prospective Randomized Trial of CPAP for SDB in Patients Who Use Opioids
CompletedPhase 2NCT04928157
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Prospective Randomized Trial of CPAP for SDB in Patients Who Use Opioids
- Conditions
- Sleep Disorder
- Breathing-Related
- Pain
- Sleep Apnea
- Obstructive Sleep Apnea
- Sleep
- Sleep Disorder
- Chronic Pain
- Opioid Use
- Interventions
- Device: Positive Airway Pressure (PAP)
- Sponsor
- University of California, San Diego
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Start date
- 2021-08-10
- Primary completion
- 2024-09-12
- Sex
- All
- Age range
- from 18 Years
- Healthy volunteers
- true
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Age 18+ * Chronic pain * Chronic opioid use (daily use for \>3 months duration) * Apnea-hypopnea index \>/= 5 events/hr (screening sleep study will be performed) Exclusion Criteria: * Already using CPAP or non-invasive ventilation on a daily basis * Use of opioids outside medical supervision (i.e. recreational use) * Pain due to active cancer * Prisoners * Pregnancy * Psychiatric illness other than treated mood disorders * Life expectancy \<12 months * Anticipated inability to sleep in the laboratory setting or to use CPAP * Unable or unwilling to provide informed consent or comply with research procedures
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04928157