150 Participants Needed

Oxygen + Acetazolamide for Sleep Apnea

(SDB Trial)

Recruiting at 1 trial location
SC
A
RR
RR
Overseen ByRuchi Rastogi, MS
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: VA Office of Research and Development
Must be taking: Opioids
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

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.12345

Why 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?

SC

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

I am a veteran prescribed opioids.
I am a veteran aged between 18 and 89.

Exclusion Criteria

I do not have severe lung, brain, liver, or kidney diseases.
I have ongoing chest pain or discomfort.
I have ongoing seizures that aren't controlled.
See 12 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment - Hyperoxia

Participants undergo sustained hyperoxia overnight to assess its effect on ventilatory control during sleep

2-30 days
Overnight study

Treatment - Acetazolamide

Participants receive oral acetazolamide therapy for 6 days to study its effect on cerebrovascular responsiveness to CO2

6 days
Experimental night study, experimental day study, polysomnography night study

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Acetazolamide
  • Hyperoxia
Trial Overview The study tests if oxygen (hyperoxia) and a drug called acetazolamide can help reduce irregular breathing and eliminate sleep apnea in people taking chronic opioid medications. It also looks at how these treatments affect life quality, sleep, and pain levels.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: HyperoxiaExperimental Treatment1 Intervention
Group II: Acetazolamide (ACZ)Experimental Treatment1 Intervention

Acetazolamide is already approved in United States, European Union, Canada for the following indications:

🇺🇸
Approved in United States as Diamox for:
🇪🇺
Approved in European Union as Diamox for:
🇨🇦
Approved in Canada as Diamox for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials
1,691
Recruited
3,759,000+

John D. Dingell VA Medical Center

Collaborator

Trials
10
Recruited
1,100+

Published Research Related to This Trial

In a study of 20 male patients with sleep apnea, 14 showed significant improvements in apnea frequency, sleep structure, and related symptoms after treatment with acetazolamide (AZM), a carbonic anhydrase inhibitor.
The treatment led to a decrease in arterial blood pH and bicarbonate levels in the improved patients, indicating a potential mechanism of action related to metabolic changes, while the remaining 6 patients did not experience any benefits from AZM.
Effects of acetazolamide on the sleep apnea syndrome and its therapeutic mechanism.Sakamoto, T., Nakazawa, Y., Hashizume, Y., et al.[2019]
A 66-year-old woman experienced irreversible anaphylactic shock and severe pulmonary edema after being prescribed acetazolamide for glaucoma, likely due to a cross-reaction with her known sulphonamide allergy.
This case highlights the critical importance of screening for sulphonamide allergies before prescribing acetazolamide, as such allergies should be considered a contraindication due to the chemical similarities between the two drugs.
[Fatal anaphylactic reaction after oral acetazolamide (diamox) for glaucoma].Gerhards, LJ., van Arnhem, AC., Holman, ND., et al.[2017]
There were three cases where acetohexamide was mistakenly given instead of acetazolamide due to their similar appearance and names, highlighting a significant risk for medication errors.
One patient experienced a severe hypoglycemic reaction leading to head trauma and confusion, which required emergency hospitalization, demonstrating the potential dangers of such medication mix-ups.
Inadvertent substitution of acetohexamide for acetozolamide.Hargett, NA., Ritch, R., Mardirossian, J., et al.[2019]

Citations

Acetazolamide for OSA and Central Sleep ApneaFurthermore, acetazolamide improved oxygen saturation nadir by +4.4% (95% CI, 2.3 to 6.5; I2 = 63%; no evidence of effect modification; very low QoE) and ...
Effects of acetazolamide on control of breathing in sleep ...Acetazolamide reduces ventilatory instability or “high loop gain” (for more details, see the “Results of Meta‐Analyses” section below Edwards et al., 2012, ...
Acute and long-term effects of acetazolamide in presumed ...The effect of acetazolamide in reducing residual sleep apnea lasts at least 3 months. •. The apnea-hypopnea index during non-rapid eye movement sleep is a ...
Study Details | NCT05804084 | Patient-centered and ...The goal of this study is to test if acetazolamide can improve sleep apnea, neurocognitive function and quality of life in adults with OSA, and to assess how it ...
The role of acetazolamide in sleep apnea at sea levelAcetazolamide improves the apnea-hypopnea index and several sleep metrics in central sleep apnea. The drug may be of clinical benefit in patients with high loop ...
Comparing standard treatment of moderate to severe ...In our study, the CPAP plus acetazolamide group demonstrated a significant reduction in both overall AHI and non-REM AHI compared to the CPAP ...
Acetazolamide for Obstructive Sleep Apnea to Improve ...Recent data suggest, that acetazolamide may help OSA patients to not choke in their sleep and lower their blood pressure. Especially young adults with OSA are ...
A Randomized Controlled Clinical Trial Exploring Safety ...There were no serious adverse events. STM reduced the apnea–hypopnea index from 55.2 to 33.0 events/h (−41.0%) in the 400-mg group and from 61.1 ...
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