Actively Recruiting

Phase 1
Phase 2
Age: 18Years - 89Years
All Genders
Healthy Volunteers
ID05589753

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

Age: 18Years - 89Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Veterans aged 18 to 89 years
  • Veterans currently prescribed opioid medications
Not Eligible

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

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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

Follow-up

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

Loading map...

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

Similar Trials

Comparison of Dexamethasone Versus Dexmedetomidine Added to ...

Pain, Postoperative

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here