Opiod Use DisorderAWAKENCT07829055
Effects of Mental Tasks on Breathing Patterns in Adults Using Chronic Opioids vs Non-opioid Users.
An observational study of Opiod Use Disorder and Obstructive Sleep Apnea, run by University of California, San Diego at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Opiod Use Disorder, Obstructive Sleep Apnea
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Sep 2026to Jun 2027
- How long will I take part?
- 1 Day
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who have been seen at UC San Diego
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of California San Diego
San Diego, California, 92037
About this study
Official title: Control of Ventilation During Wakefulness in Opioid vs. Non-opioid Patients
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?
Read more
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
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Opioid Use | Not described | |
| Obstructive Sleep Apnea | Not described | |
| Healthy Control Group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory pattern changes during standardized cognitive load tasks
Measured: 2 hours
Respiratory variability/irregularity
Measured from breathing signals (nasal pressure/airflow, thoracoabdominal effort belts, end-tidal CO2) during cognitive tasks vs. baseline
Measured: 2 hours
Secondary outcomes (1)
EEG-respiratory coupling
cortical-respiratory coupling - the degree of association between EEG activity and respiratory signal timing
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2026
- Study start16 Sep 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opiod Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeremy Orr, M.D., University of California, San Diego
- Investigators
- Jeremy Orr, MD, Principal investigator, UC San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07829055
- Sponsor's protocol ID
- 815022
- Acronym
- AWAKE
- Status last verified
- Sep 2026
- First submitted
- 14 Sep 2026
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes