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Not recruiting
Phase 2

Acetazolamide

Sponsor:

UCLA

Code:

NCT05616260

Conditions

Obstructive Sleep Apnea

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Not accepted

Interventions

Acetazolamide

Placebo

Continuous Positive Airway Pressure

Study Details

Brief summary:

Obstructive sleep apnea (OSA) is a severe type of snoring causing people to choke in their sleep. It affects millions of Americans, causing many health problems. For example, patients with OSA often feel very sleepy and are at risk of falling asleep while driving. OSA also causes elevated blood pressure increasing the risk for heart attacks and strokes. Patients with OSA are often treated with a face-mask that helps them breath at night but can be difficult to tolerate. In fact, about half the patients eventually stop using this mask. Because there are few other treatments (and no drug therapy), many OSA patients are still untreated. Of note, especially young adults (i.e. 18 to 50 years old) benefit from treating their OSA, but they are also less likely to use the mask.

Acetazolamide (a mild diuretic drug) has been used for over 50 years to treat many different conditions and is well tolerated. 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 likely to respond well to this drug. Further, its low cost (66¢/day) and once- daily dosing may be particularly attractive for young OSA patients unable or unwilling to wear a mask each night. But previous studies had many limitations and did not focus on young adults. The goal of this study is to test if acetazolamide can improve sleep apnea and cardiovascular health in young adults with OSA (18-50 years old), and how it does that. Thus, we will treat 46 young OSA patients with acetazolamide or placebo for 2 weeks each. The order in which participants receive the drug or placebo will be randomized. At the end of each 2 week period we will assess OSA severity and cardiovascular health. Thus, this study will help assess acetazolamide's potential value for OSA treatment, and may also help to identify patients who are most likely to respond to acetazolamide (including select individuals >50 years of age).

Ultimately, this work promises a drug therapy option for millions of OSA patients who are unable to tolerate current treatments.

Conditions

Obstructive Sleep Apnea

Study ID

NCT05616260

Start date

Dec 2, 2022

Status verified date

Feb, 2025

Completion date

Apr 30, 2025

Anticipated

Primary completion date

Apr 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age 18 to 50 years
  • Body mass index ≤ 35 kg/m2
  • Untreated OSA (AHI ≥10/h)
  • Abnormal blood pressure (>120/80mmHg, or on stable anti-hypertensive therapy for >1month)

Exclusion Criteria:

  • Substantial sleep hypoxemia (SpO2<80% for >10% of the monitoring time during the home sleep test, or for >25% of the total sleep time during any of the in-laboratory studies)
  • Severe uncontrolled hypertension (>160/110mmHg during baseline assessment; >180/120mmHg during follow up assessments)
  • Abnormally low blood counts/electrolytes or renal function at baseline
  • Mean use of OSA therapy ≥ 1h/night during past 1 month, or plans to urgently resume/(re)start clinical OSA therapy within 2 months
  • Significant, uncontrolled cardiac, pulmonary, endocrine, renal, hepatic, neurocognitive, psychiatric, or urologic (e.g., kidney stones) disorder
  • Other major sleep disorder (e.g., narcolepsy)
  • Urgent need to initiate effective OSA therapy (i.e., Epworth sleepiness score >18, commercial driver, prior sleep-related car accident, or based on MD judgment)
  • Severe allergy to sulfa-drugs or taking another carbonic-anhydrase inhibitor (e.g., topiramate, zonisamide)
  • Pregnancy/breastfeeding (current/planned)
  • Prisoners
  • Illicit substance abuse or >2 standard drinks of alcohol/day
  • Medications that may affect OSA or ventilatory control (e.g., opiates, sedatives)
  • Thiazide/loop diuretic (risk of hypokalemia)
  • Inability to give consent or follow procedures
  • Safety concern based on MD judgment

Study Design

Enrollment

46 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Acetazolamide, then Placebo, then optional open-label CPAP-therapy

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

experimental: Placebo, then Acetazolamide, then optional open-label CPAP-therapy

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

Interventions

Acetazolamide

Acetazolamide tablet (encapsulated)

Placebo

Sugar capsule manufactured to match encapsulated Acetazolamide

Continuous Positive Airway Pressure

Standard CPAP device

Primary outcome measure

  • Apnea Hypopnea Index [ Time Frame: 14 days ]
  • 24-hour Mean Blood Pressure [ Time Frame: 14 days ]

Central Contacts and Locations

Central contacts

Pamela DeYoung, RPSGT

858 246 2183sleepresearch@health.ucsd.edu

Locations

UC San Diego; Altman Clinical and Translational Research Institute Building

Recruiting

La Jolla, California, United States, 92121

Contacts

Pamela DeYoung, RPSGT

858-246-2183sleepresearch@health.ucsd.edu

More Information

Sponsor

University of California, San Diego

Last update posted

Feb 14, 2025

Last verified

Feb, 2025

Keywords

  • obstructive sleep apnea
  • OSA
  • CPAP
  • Acetazolamide

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-19. This information was provided to ClinicalTrials.gov by University of California, San Diego on 2025-02-14.