Actively Recruiting
Targeting Chemoreceptor Control of Breathing During Sleep to Mitigate Opioid-Associated Sleep Disordered Breathing
Led by VA Office of Research and Development · Updated on 2025-07-18
150
Participants Needed
1
Research Sites
12 weeks
Total Duration
On this page
Sponsors
V
VA Office of Research and Development
Lead Sponsor
J
John D. Dingell VA Medical Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to understand and find new treatments for sleep disordered breathing (SDB) linked to chronic prescription opioid use, especially among Veterans. Since SDB and opioid use together increase risks like central sleep apnea and related complications, the study investigates how opioid use affects breathing control and explores ways to improve breathing stability and sleep quality. The goal is to better understand the mechanisms causing sleep apnea in opioid users and identify potential therapies to improve health outcomes. Participants will be randomly assigned to one of two treatment groups. One group will receive sustained hyperoxia (increased oxygen) overnight to study its effects on breathing control during sleep. The other group will take acetazolamide, a medication taken orally twice daily for six days, with various sleep and breathing tests done during and after treatment, including overnight sleep studies. These interventions aim to reduce unstable breathing and sleep apnea by targeting different physiological pathways. During the study, participants will undergo detailed tests of breathing and brain blood flow responsiveness to carbon dioxide during sleep and wakefulness. Assessments include polysomnography (sleep studies), measurement of ventilatory responses, apnea severity, and quality of life. The trial will monitor changes over days to weeks, with primary outcomes focusing on breathing stability measures. Participants will be followed for up to 30 days to evaluate the effects of treatments and their impact on sleep and breathing patterns.
CONDITIONS
Brief Title
Sleep Disordered Breathing With Opioid Use
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Veterans aged 18 to 89 years
- Veterans currently prescribed opioid medications
You will not qualify if you...
- Body mass index over 40 kg/m2
- History of unresolved or untreated cardiac disease, including recent heart attack or bypass surgery
- Untreated atrial and ventricular tachy-bradycardias
- Congestive heart failure with Cheyne-Stokes respiration
- Current unstable angina
- Recent stroke
- Untreated schizophrenia
- Untreated hypothyroidism
- Unresolved seizure disorder
- Severe respiratory, neurological, liver, or kidney diseases
- Unstable psychiatric disorders or untreated PTSD
- Traumatic brain injury
- Pregnancy
- Significant sleep disorders such as narcolepsy or parasomnias
- Failure to give informed consent
- Current use of tramadol or suboxone/buprenorphine
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 days for acetazolamide therapy; hyperoxia exposure overnight sessions
Participants will receive two experimental interventions in a crossover design: sustained hyperoxia overnight versus room air overnight, and oral acetazolamide 500 mg twice a day for 6 days. Effects on breathing control during sleep and cerebrovascular responsiveness will be assessed.
Multiple visits including experimental night and day studies, and polysomnography night studies
Duration - Up to 30 days
Participants are monitored after treatment to assess the lasting effects on breathing instability and cerebrovascular responsiveness related to opioid-associated sleep disordered breathing.
1 to 2 visits depending on assessments
Trial Site Locations
Total: 1 location
1
John D. Dingell VA Medical Center, Detroit, MI
Detroit, Michigan, United States, 48201-1916
Actively Recruiting
Research Team
R
Ruchi Rastogi, MS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
OTHER
Number of Arms
2
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