Summary

Eligibility
for people ages 45-65 (full criteria)
Healthy Volunteers
healthy people welcome
Location
at San Diego, California
Dates
study started
study ends around
Principal Investigator
by Jeremy Orr, MD
Headshot of Jeremy Orr
Jeremy Orr

Description

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.

Official Title

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

Keywords

Opiod Use Disorder, Obstructive Sleep Apnea, control of breathing, sleep study, polysomnography, lung, pulmonary, Opioid Use

Eligibility

You can join if…

Open to people ages 45-65

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 CAN'T join 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

Location

  • University of California San Diego
    San Diego California 92037 United States

Lead Scientist at UCSD

  • Jeremy Orr, MD
    Associate Clinical Professor, Medicine, Vc-health Sciences-schools. Authored (or co-authored) 81 research publications. Research interests: Mechanical ventilation · Control of breathing · Chronic lung disease · Sleep apnea · Noninvasive ventilation · Respiratory neuromuscular weakness · Hypoxemia

Details

Status
accepting new patients by invitation only
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Diego
ID
NCT07829055
Study Type
Observational [Patient Registry]
Participants
Expecting 40 study participants
Last Updated