Oxygen + Acetazolamide for Sleep Apnea
(SDB Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether oxygen and a medication called acetazolamide can reduce breathing problems during sleep for individuals who regularly take opioids. It aims to determine if these treatments can enhance sleep quality and overall well-being. The trial tests two treatments: one involves breathing extra oxygen at night, and the other involves taking acetazolamide pills. Veterans currently using prescription opioids and experiencing sleep issues might be suitable candidates. As a Phase 1, Phase 2 trial, it focuses on understanding how the treatments work and measuring their effectiveness in an initial group, offering participants a chance to contribute to important research.
Do I have to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications, but it does exclude patients on tramadol and suboxone/buprenorphine. It seems you can continue other prescription opioids.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that acetazolamide, a treatment under study for sleep apnea, is generally well-tolerated. A review of 26 studies found that acetazolamide reduced the severity of sleep apnea without causing serious side effects, suggesting it can be safe for managing the condition.
For hyperoxia treatment, studies have indicated that oxygen therapy can improve oxygen levels in people with sleep apnea. However, the overall safety results are limited and sometimes mixed. Discuss any concerns with a study doctor.
Both treatments have undergone testing. If questions arise about joining a trial, inquire about any risks.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments because they offer new ways to tackle sleep apnea. Unlike the standard of care, which often involves CPAP machines or oral appliances, acetazolamide works by affecting the body's response to carbon dioxide, potentially offering an alternative for those who struggle with current options. Meanwhile, the hyperoxia treatment aims to change how the body regulates breathing during sleep by increasing oxygen levels, which could help manage apnea episodes more effectively. These approaches are promising because they target the underlying physiological processes of sleep apnea, rather than just addressing its symptoms.
What evidence suggests that this trial's treatments could be effective for sleep apnea?
Research has shown that acetazolamide, which participants in this trial may receive, can help treat sleep apnea by stabilizing breathing during sleep. It improves blood oxygen levels and reduces the severity of sleep apnea episodes. Acetazolamide also controls breathing by reducing high loop gain, a condition where the breathing system is overly sensitive. Similarly, studies have found that oxygen therapy, another treatment option in this trial, decreases the number of sleep apnea events and improves blood oxygen levels. Both treatments could benefit people with sleep apnea, including those taking opioid medications.13678
Who Is on the Research Team?
Susmita Chowdhuri, MD
Principal Investigator
John D. Dingell VA Medical Center, Detroit, MI
Are You a Good Fit for This Trial?
This trial is for veterans aged 18-89 who are on prescription opioids and may have sleep issues like apnea due to their medication. It's not open to those with severe untreated mental or physical health conditions, recent strokes or heart problems, pregnant women, very high BMI (>40), or anyone unable to consent.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment - Hyperoxia
Participants undergo sustained hyperoxia overnight to assess its effect on ventilatory control during sleep
Treatment - Acetazolamide
Participants receive oral acetazolamide therapy for 6 days to study its effect on cerebrovascular responsiveness to CO2
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Acetazolamide
- Hyperoxia
Acetazolamide is already approved in United States, European Union, Canada for the following indications:
- Glaucoma
- Epilepsy
- Edema
- Altitude sickness
- Glaucoma
- Epilepsy
- Edema
- Glaucoma
- Epilepsy
- Edema
- Altitude sickness
Find a Clinic Near You
Who Is Running the Clinical Trial?
VA Office of Research and Development
Lead Sponsor
John D. Dingell VA Medical Center
Collaborator