46 Participants Needed

Acetazolamide for Obstructive Sleep Apnea

(ACE-Of-HEARTs Trial)

PD
Overseen ByPamela DeYoung, RPSGT
Age: 18 - 65
Sex: Any
Trial Phase: Phase 2
Sponsor: University of California, San Diego
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 3 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

This trial tests acetazolamide, a mild diuretic drug, in young adults with obstructive sleep apnea and high blood pressure. The drug aims to improve breathing during sleep and lower blood pressure. Researchers will evaluate its effectiveness for those who struggle with current therapies. Acetazolamide has been investigated for its potential to reduce blood pressure and improve sleep-disordered breathing in patients with hypertension and obstructive sleep apnea.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking certain medications like opiates, sedatives, or specific diuretics. It's best to discuss your current medications with the trial team to see if they affect your eligibility.

What evidence supports the effectiveness of the drug acetazolamide for obstructive sleep apnea?

Research shows that acetazolamide can reduce the number of apnea episodes and improve sleep quality in some patients with obstructive sleep apnea. It works by affecting blood pH and breathing control, which can help stabilize breathing during sleep.12345

Is acetazolamide generally safe for humans?

Acetazolamide is generally safe for humans, but there are important safety considerations. A fatal allergic reaction (anaphylactic shock) has been reported in a person with a sulfonamide allergy, so it's crucial to check for this allergy before using acetazolamide.678910

How does the drug acetazolamide differ from other treatments for obstructive sleep apnea?

Acetazolamide is unique because it works by increasing the body's drive to breathe through its effect on carbon dioxide levels, which can help stabilize breathing during sleep. It is particularly beneficial for mild cases of obstructive sleep apnea and is sometimes used in combination with other treatments for more severe cases.1351112

Research Team

CS

Christopher Schmickl, MD, PhD

Principal Investigator

University of California, San Diego

Eligibility Criteria

This trial is for young adults aged 18-50 with untreated obstructive sleep apnea (OSA), a body mass index ≤35, and abnormal blood pressure. It's not for those allergic to sulfa-drugs, using certain medications, abusing substances, or with severe health issues like uncontrolled hypertension or major organ disorders.

Inclusion Criteria

I am between 18 and 50 years old.
I have untreated sleep apnea with an AHI of 10 or more.
You have a body mass index of 35 or lower.
See 1 more

Exclusion Criteria

Prisoners
I am unable to understand or follow the study's procedures.
Safety concern based on MD judgment
See 12 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks
1 visit (in-person), 1 visit (virtual)

Treatment Phase 1

Participants receive either acetazolamide or placebo for 2 weeks, with weekly check-ins and monitoring of sleep and cardiovascular health

2 weeks
1 visit (in-person), weekly check-ins (virtual)

Wash-out

A wash-out period between treatment phases to clear the effects of the first treatment

1-2 weeks

Treatment Phase 2

Participants receive the alternate treatment (acetazolamide or placebo) for 2 weeks, with weekly check-ins and monitoring of sleep and cardiovascular health

2 weeks
1 visit (in-person), weekly check-ins (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2-4 weeks

Optional Open-label CPAP

Participants may opt into a 2-week CPAP therapy and repeat the same activities as during the treatment phases

2 weeks

Treatment Details

Interventions

  • Acetazolamide
Trial OverviewThe study tests if acetazolamide can improve OSA and heart health in young adults. Participants will be randomly given either the drug or a placebo for two weeks each, with assessments of OSA severity and cardiovascular health after each period.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Placebo, then Acetazolamide, then optional open-label CPAP-therapyExperimental Treatment3 Interventions
Subjects will start with a 2-week PLACEBO regimen * Day 1-13: Placebo (matching Acetazolamide 500mg) at bedtime at home * Day 14: Placebo (matching Acetazolamide 500mg) at bedtime in the sleep laboratory After a wash-out period, subjects will then cross-over to a 2-week ACETAZOLAMIDE regimen: * Day 1-13: Acetazolamide 500mg at bedtime at home * Day 14: Acetazolamide 500mg at bedtime in the sleep laboratory After a wash-out period, subjects may then undergo an OPTIONAL, OPEN-LABEL 2-week CPAP regimen: - Day 1-14: CPAP will be used at home during sleep
Group II: Acetazolamide, then Placebo, then optional open-label CPAP-therapyExperimental Treatment3 Interventions
Subjects will start with a 2-week ACETAZOLAMIDE regimen * Day 1-13: Acetazolamide 500mg at bedtime at home * Day 14: Acetazolamide 500mg at bedtime in the sleep laboratory After a wash-out period, subjects will then cross-over to a 2-week PLACEBO regimen: * Day 1-13: Placebo (matching Acetazolamide 500mg) at bedtime at home * Day 14: Placebo (matching Acetazolamide 500mg) at bedtime in the sleep laboratory After a wash-out period, subjects may then undergo an OPTIONAL, OPEN-LABEL 2-week CPAP regimen: - Day 1-14: CPAP will be used at home during sleep

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

🇺🇸
Approved in United States as Diamox for:
  • Glaucoma
  • Epilepsy
  • Edema
  • Altitude sickness
🇪🇺
Approved in European Union as Diamox for:
  • Glaucoma
  • Epilepsy
  • Edema
🇨🇦
Approved in Canada as Diamox for:
  • Glaucoma
  • Epilepsy
  • Edema
  • Altitude sickness

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials
1,215
Recruited
1,593,000+

Findings from Research

Acetazolamide significantly improves sleep apnea at high altitudes by reducing the Apnea-Hypopnea Index (AHI) and increasing nocturnal oxygenation, particularly in healthy trekkers compared to those with obstructive sleep apnea (OSA).
A daily dose of 250 mg of acetazolamide may be as effective as higher doses for healthy individuals, suggesting a potential optimal therapeutic dose for treating sleep apnea in high-altitude conditions.
The effect of acetazolamide on sleep apnea at high altitude: a systematic review and meta-analysis.Liu, HM., Chiang, IJ., Kuo, KN., et al.[2018]
Acetazolamide (AZT) significantly improved sleep apnea symptoms in patients with high loop gain sleep apnea (HLGSA) both acutely and over a 3-month period, showing a notable reduction in the apnea hypopnea index (AHI) and breathing-related arousal index when combined with positive airway pressure (PAP) therapy.
The study involved 231 participants, with a strong predictor for treatment response being the non-rapid eye movement (NREM) AHI, indicating that AZT is a well-tolerated and effective option for managing HLGSA.
Acute and long-term effects of acetazolamide in presumed high loop gain sleep apnea.Ni, YN., Holzer, RC., Thomas, RJ.[2023]
In a study of nine patients with obstructive sleep apnoea, acetazolamide (250 mg/day) significantly reduced the apnoea index from 25.0 to 18.1 episodes per hour and decreased the total time of arterial oxygen desaturation during sleep.
Acetazolamide appears to improve symptoms of daytime hypersomnolence in some patients and enhances ventilatory control by increasing the body's response to carbon dioxide, suggesting it may be beneficial for mild cases of obstructive sleep apnoea, although it does not completely eliminate apnoea.
Effects of acetazolamide in patients with the sleep apnoea syndrome.Tojima, H., Kunitomo, F., Kimura, H., et al.[2019]

References

The effect of acetazolamide on sleep apnea at high altitude: a systematic review and meta-analysis. [2018]
Acute and long-term effects of acetazolamide in presumed high loop gain sleep apnea. [2023]
Effects of acetazolamide in patients with the sleep apnoea syndrome. [2019]
Central sleep apnea. Improvement with acetazolamide therapy. [2013]
Effects of acetazolamide on the sleep apnea syndrome and its therapeutic mechanism. [2019]
Inadvertent substitution of acetohexamide for acetozolamide. [2019]
Effectiveness of generic acetazolamide. [2019]
[Fatal anaphylactic reaction after oral acetazolamide (diamox) for glaucoma]. [2017]
Efficacy of dorzolamide hydrochloride in the management of chronic cystoid macular edema in patients with retinitis pigmentosa. [2019]
10.United Statespubmed.ncbi.nlm.nih.gov
Short-term dose response characteristics of acetazolamide in man. [2019]
11.United Statespubmed.ncbi.nlm.nih.gov
Acetazolamide for OSA and Central Sleep Apnea: A Comprehensive Systematic Review and Meta-Analysis. [2022]
Clinical efficacy and indication of acetazolamide treatment on sleep apnea syndrome. [2013]