Sleep Disordered Breathing with Opioid Use in Veterans

This study is for Veterans who use prescription opioids and have sleep apnea or other sleep-disordered breathing. Researchers want to see if oxygen (Hyperoxia) or a medication called acetazolamide can help reduce unstable breathing and sleep apnea in these individuals. They will measure how breathing changes and how the brain responds to carbon dioxide to understand if these interventions are effective. The study aims to improve understanding of how opioids affect breathing during sleep and ultimately develop better treatments. You may be eligible if you are a Veteran between 18 and 89 years old and use prescription opioids. The study's status is currently unclear, and it plans to enroll 150 participants.

Study design
This is an interventional study planning to enroll 150 participants. It will compare the effects of oxygen and acetazolamide to a placebo.
What's involved
Participants will ingest capsules (either placebo or acetazolamide) twice a day for 6 days. This includes physiology tests and an in-lab sleep study (PSG) on the final 4 nights.
Compensation
Not stated in the trial record.
Follow-up
Breathing instability and ventilatory responsiveness will be measured for up to 30 days, and cerebrovascular responsiveness for 7 days.

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NCT05589753

Sleep Disordered Breathing With Opioid Use

Recruiting
PHASE1Ages 18–89Interventional
VA Office of Research and Development
~150 participants
Updated 2026-07-01 on ClinicalTrials.gov
What's tested:HyperoxiaAcetazolamide

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Apneic threshold - a measure of breathing instability
Measured over 2 days to 30 days
+3 more outcomes measured
Sleep Apnea
Opioid Use
Sleep Disordered Breathing
1 sites across 1 states
Michigan1
  • Susmita Chowdhuri, MD MS · PRINCIPAL_INVESTIGATOR · John D. Dingell VA Medical Center, Detroit, MI

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Eligibility criteria

Inclusion

Veterans, age 18-89 years
Veterans with prescription opioids

Exclusion

Patients with BMI\>40kg/m2 will be excluded to avoid the effects of morbid obesity on pulmonary mechanics and ventilatory control
Patients with history of unresolved/untreated cardiac disease, including recent myocardial infarction, recent bypass surgery, untreated atrial and ventricular tachy-bradycardias
Congestive heart failure with Cheyne-Stokes respiration (CSR)
Current unstable angina
Recent stroke
Untreated schizophrenia
Untreated hypothyroidism
Unresolved seizure disorder
Severe respiratory, neurological, liver and renal diseases
Unstable psychiatric disorders/untreated PTSD
Traumatic brain injury
Pregnant women
Significant sleep disorder such as narcolepsy, parasomnias disorder
Failure to give informed consent
Patients on tramadol and suboxone/buprenorphine
  • Apneic threshold - a measure of breathing instability2 days to 30 days

    Measures of breathing instability including: Apneic threshold: this is the end-tidal Co2 at which a central apnea closes to a hypopnea is produced.

  • Cerebrovascular responsiveness to carbon-dioxide7 days

    Cerebrovascular response to different levels of CO2: this is a measure of the response of the cerebral blood flow to changes in carbon dioxide levels and is used as a measure of ventilatory control of breathing

  • Ventilatory responsiveness2 days to 30 days

    Hypocapnic ventilatory response; this is calculated as the change in minute ventilation for corresponding changes in PETCO2.

  • Carbon-dioxide reserve2 days to 30 days

    This is a derived measure. This is calculated as the difference between the apneic threshold PETCO2 (given above) and the control PETCO2.