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
- Are there results?
- Not yet: the study is under way
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)
Show all 13Show fewer
- 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
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Control of Ventilation During Wakefulness in Opioid vs. Non-opioid Patients
- ClinicalTrials.gov ID
- NCT07829055
- Acronym / sponsor ID
- AWAKE / 815022
- Conditions
- Opiod Use Disorder, Obstructive Sleep Apnea
- Keywords
- control of breathing, sleep study, polysomnography, lung, pulmonary
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 16 Sep 2026 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 18 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Opioid Use | – | – |
| Obstructive Sleep Apnea | – | – |
| Healthy Control Group | – | – |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have been seen at UC San Diego
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
EEG-respiratory coupling
Time frame: 2 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Individual participant dataSharing planned: Yes
Related trials for Opiod Use Disorder
Active, not recruitingObservational study
EEG Biomarkers for OUD: Diagnostic, Prognostic, and Predictive Applications
Opiod Use Disorder
Not yet recruiting
Chicago Data-driven Opioid Use Disorder Screening, Engagement, Treatment and Planning System
Opiod Use Disorder
Recruiting
Vanderbilt Integrated Community TMS for Opioid Recovery
Opiod Use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jeremy Orr, MD principal investigator
UC San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Opiod Use Disorder and Obstructive Sleep Apnea, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory pattern changes during standardized cognitive load tasks (time frame: 2 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.