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Sleep Disordered Breathing With Opioid Use

RecruitingPhase 1, Phase 2Ages 18 Years - 89 YearsAllVA Office of Research and Development
NCT05589753 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Veterans, age 18-89 years * Veterans with prescription opioids Exclusion Criteria: * 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
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What it tests

  • Hyperoxia
  • Acetazolamide
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Where

1 site
John D. Dingell VA Medical Center, Detroit, MI
Detroit, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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