Prospective Randomized Trial of CPAP for SDB in Patients Who Use Opioids

NCT04928157 | Completed Phase 2 DMC FDA Device

• 2 other identifiers: 201743K23HL151880
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sleep Disorder; Breathing-Related; Pain; Sleep Apnea; Obstructive Sleep Apnea; Sleep; Sleep Disorder; Chronic Pain; Opioid Use

Keywords

sleep; sleep apnea; OSA

Outcome Measures

Primary Outcomes (1)

• PROMIS sleep disturbance

  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.

  8 weeks

Secondary Outcomes (1)

• Brief pain inventory

  8 weeks

Other Outcomes (11)

• Pain 11 point Likert scale

  8 weeks

• Insomnia Severity Index (ISI)

  8 weeks

• PROMIS Sleep-Related Impairment (SRI)

  8 weeks

Study Arms (2)

CPAP

EXPERIMENTAL

Use of CPAP, a device used with a nose or face mask which delivers airflow/pressure into the airway, holding the airway open and keeping it from collapsing. Device will be used for 8 weeks.

Device: Positive Airway Pressure (PAP)

Control

NO INTERVENTION

No CPAP use, otherwise usual care

Interventions

Positive Airway Pressure (PAP) DEVICE

A device used with a nose or face mask which delivers airflow/pressure into the airway, holding the airway open and keeping it from collapsing. Device will be used for 8 weeks.

Also known as: CPAP

CPAP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Diego: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of California San Diego

San Diego, California, 92037, United States

Location

Related Publications (1)

• Orr JE, Bosompra NO, Norby B, Velazquez J, Khalaf A, DeYoung P, Schmickl CN, Sands SA, Jain S, He F, Goodin B, Wallace M, Owens RL, Malhotra A. Chronic pain is associated with sleep apnea severity but attenuated by intermittent hypoxemia in people using opioids. Pain. 2026 Jan 1;167(1):159-167. doi: 10.1097/j.pain.0000000000003760. Epub 2025 Jul 24.

  PMID: 40705710 DERIVED

Related Links

• UCSD Sleep Research Website

MeSH Terms

Conditions

Sleep Wake Disorders; Pain; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Chronic Pain

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias

Study Officials

• Jeremy Orr, MD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 9, 2021
• First Posted: June 16, 2021
• Study Start: August 10, 2021
• Primary Completion: September 12, 2024
• Study Completion: September 12, 2024
• Last Updated: December 2, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

US (1)