Effects of Mental Tasks on Breathing Patterns in Adults Using Chronic Opioids vs Non-opioid Users.

NCT07829055 | Enrolling By Invitation

• 1 other identifier: 815022
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to find out if using your brain for a mental task changes how you breathe. Researchers want to compare three groups of adults: people who take opioid pain medicine every day, people with sleep apnea, and healthy people with neither condition. The main questions this study aims to answer are:

• Does breathing change differently during mental tasks in people who take opioids, people with sleep apnea, and healthy controls?
• Is the connection between brain activity and breathing disrupted more in people who use chronic opioids or have OSA, compared with healthy controls, during periods of mental effort? Researchers will compare the three groups to see if opioid use or sleep apnea makes breathing less steady, or weakens the link between the brain and breathing, when a person is concentrating on a task. Participants will visit the UC San Diego Sleep Laboratory one time. During the visit, they will:
• Answer questions about sleep, opioid use, and sleep apnea risk.
• Have sensors placed on their skin and scalp to measure brain waves, breathing, and oxygen levels. This is the same kind of equipment used in a regular sleep study, and it does not hurt.
• Sit quietly and rest while their breathing and brain waves are recorded.
• Do a series of short mental tasks on a computer, tablet, or paper, testing things like memory, attention, and thinking speed, while their breathing and brain waves continue to be recorded. No medicine or treatment will be given during the study, and no blood or other samples will be collected. This study only involves watching and measuring, not testing any treatment.

Conditions

Opiod Use Disorder; Obstructive Sleep Apnea

Keywords

control of breathing; sleep study; polysomnography; lung; pulmonary

Outcome Measures

Primary Outcomes (2)

• Respiratory pattern changes during standardized cognitive load tasks

  2 hours

• Respiratory variability/irregularity

  Measured from breathing signals (nasal pressure/airflow, thoracoabdominal effort belts, end-tidal CO2) during cognitive tasks vs. baseline

  2 hours

Secondary Outcomes (1)

• EEG-respiratory coupling

  2 hours

Study Arms (3)

Opioid Use

Obstructive Sleep Apnea

Healthy Control Group

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who have been seen at UC San Diego

You may qualify if:

• All participants
• Able to provide informed consent
• Able to communicate in English, see/hear task stimuli (with usual corrective devices), follow multistep instructions, and complete a brief cognitive-task practice example
• Opioid group
• Daily prescribed opioid use, under medical supervision, for chronic non-cancer pain, for ≥3 months
• Prescribed dose ≥20 MME/day (no upper limit)
• Stable dose for ≥2 weeks
• OSA group
• \- Diagnosed OSA with AHI ≥15 events/hour (documented on a prior clinical sleep study)
• Healthy control group
• No history of chronic prescribed opioid use
• No known history/diagnosis of OSA
• If a prior sleep study exists, AHI must be \<10 events/hour within the past 3 years

You may not qualify if:

• Prisoners
• Pregnancy
• BMI \<20 or \>35
• Unable/unwilling to give informed consent or comply with study procedures
• Significant comorbidities of other organ systems (e.g., chronic kidney disease, CHF/active cardiac symptoms, cirrhosis, severe lung disease)
• Diseases affecting respiratory muscles or breathing control (neuromuscular, neurodegenerative, congenital)
• Psychiatric disease other than controlled mood disorders

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

University of California San Diego

San Diego, California, 92037, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Jeremy Orr, MD

  UC San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: September 14, 2026
• First Posted: September 18, 2026
• Study Start: September 16, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: September 18, 2026

Record last verified: 2026-09

Data Sharing

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

Locations

US (1)