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

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.

Enrolling by invitation

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Key information

Conditions

Opiod Use Disorder Apnea Dyssomnias Nervous System Diseases Obstructive Sleep Apnea Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

45 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of California San Diego

San Diego, California, 92037, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

Respiratory pattern changes during standardized cognitive load tasks

Time frame: 2 hours
Respiratory variability/irregularity

Time frame: 2 hours

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

Secondary outcomes

EEG-respiratory coupling

Time frame: 2 hours

cortical-respiratory coupling - the degree of association between EEG activity and respiratory signal timing

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Registry information

Official study title

Control of Ventilation During Wakefulness in Opioid vs. Non-opioid Patients

Acronym: AWAKE

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: Sep 18, 2026
Registry last updated: Sep 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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