Actively Recruiting

Phase 1
Phase 2
Age: 18Years - 89Years
All Genders
Healthy Volunteers
NCT05589753

Sleep Disordered Breathing With Opioid Use

Led by VA Office of Research and Development · Updated on 2025-07-18

150

Participants Needed

1

Research Sites

412 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

There is an increased risk for sleep disordered breathing (SDB), sleep-related hypoventilation and irregular breathing in individuals on chronic prescription opioid medications. Almost 30% of a veteran sleep clinic population had opioid-associated central sleep apnea (CSA). The proposal aims to identity whether oxygen and acetazolamide can be effective in reducing unstable breathing and eliminating sleep apnea in chronic opioid use via different mechanisms. We will study additional clinical parameters like quality of life, sleep and pain in patients with and without opioid use. This proposal will enhance the investigators' understanding of the pathways that contribute to the development of sleep apnea with opioid use. The investigators expect that the results obtained from this study will positively impact the health of Veterans by identifying new treatment modalities for sleep apnea.

CONDITIONS

Official 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 using prescription opioids
Not Eligible

You will not qualify if you...

  • Body mass index (BMI) over 40 kg/m2
  • History of unresolved or untreated cardiac disease, including recent heart attack, recent bypass surgery, and untreated atrial or 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

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Trial Site Locations

Total: 1 location

1

John D. Dingell VA Medical Center, Detroit, MI

Detroit, Michigan, United States, 48201-1916

Actively Recruiting

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Research Team

R

Ruchi Rastogi, MS

CONTACT

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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