Investigating treatments for sleep apnea in veterans using opioids
Targeting Chemoreceptor Control of Breathing During Sleep to Mitigate Opioid-Associated Sleep Disordered Breathing
PHASE1; PHASE2 · VA Office of Research and Development · NCT05589753
This study is testing whether certain treatments can help veterans with sleep apnea who use opioids breathe better and improve their quality of life.
Quick facts
| Phase | PHASE1; PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 89 Years |
| Sex | All |
| Sponsor | VA Office of Research and Development (fed) |
| Locations | 1 site (Detroit, Michigan) |
| Trial ID | NCT05589753 on ClinicalTrials.gov |
What this trial studies
This study aims to explore the effects of chronic prescription opioid use on sleep disordered breathing (SDB) in veterans, particularly focusing on central sleep apnea (CSA). It will investigate whether interventions such as sustained hyperoxia and acetazolamide can effectively reduce unstable breathing and alleviate sleep apnea symptoms. The study will also assess various clinical parameters, including quality of life, sleep, and pain in both opioid users and non-users. By understanding the mechanisms contributing to SDB in opioid users, the research seeks to develop new personalized therapies for this condition.
Who should consider this trial
Good fit: Ideal candidates for this study are veterans aged 18-89 who are currently prescribed opioids.
Not a fit: Patients with significant comorbidities such as severe respiratory diseases or untreated psychiatric disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new treatment options for veterans suffering from sleep apnea associated with opioid use.
How similar studies have performed: While there is limited research specifically targeting this combination of factors, the study's approach is novel and aims to address a significant gap in understanding the relationship between opioid use and sleep apnea.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Detroit, Michigan
- John D. Dingell VA Medical Center, Detroit, MI — Detroit, Michigan, United States (RECRUITING)
Study contacts
- Principal investigator: Susmita Chowdhuri, MD MS — John D. Dingell VA Medical Center, Detroit, MI
- Study coordinator: Ruchi Rastogi, MS
- Email: ruchi.rastogi@va.gov
- Phone: (313) 576-4464
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Sleep Apnea, Opioid Use, Sleep Disordered Breathing