NCT05804084 Patient-centered and Neurocognitive Outcomes With Acetazolamide for Sleep Apnea
| NCT ID | NCT05804084 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of California, San Diego |
| Condition | Obstructive Sleep Apnea |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2023-05-16 |
| Primary Completion | 2026-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 60 participants in total. It began in 2023-05-16 with a primary completion date of 2026-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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, memory problems and can severely affect quality of life. 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. 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. Further, its low cost (66¢/day) and once-daily dosing may be attractive for OSA patients unable or unwilling to wear a mask each night. But previous studies had many limitations such as studying acetazolamide for only a few days and not capturing important outcomes. 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 does that. Thus, the investigators will treat 60 OSA patients with acetazolamide or placebo for 4 weeks each. The order in which participants receive the drug or placebo will be randomized. At the end of each 4 week period the investigators will assess OSA severity, neurocognitive function and quality of life. 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. Ultimately, this work promises a drug therapy option for millions of OSA patients who are unable to tolerate current treatments
Eligibility Criteria
Inclusion Criteria: * Age ≥18 years * Body mass index ≤ 35 kg/m2 * Untreated moderate/severe OSA (AHI ≥15/h) 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) * Abnormally low blood counts/electrolytes or renal function at baseline * Use of OSA therapy during the past 1 month, or plans to urgently resume/(re)start clinical OSA therapy within 3 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) * 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
Contact & Investigator
Christopher N Schmickl, MD, PhD
PRINCIPAL INVESTIGATOR
University of California, San Diego
Frequently Asked Questions
Who can join the NCT05804084 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Obstructive Sleep Apnea. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05804084 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05804084 currently recruiting?
Yes, NCT05804084 is actively recruiting participants. Contact the research team at sleepresearch@health.ucsd.edu for enrollment information.
Where is the NCT05804084 trial being conducted?
This trial is being conducted at La Jolla, United States.
Who is sponsoring the NCT05804084 clinical trial?
NCT05804084 is sponsored by University of California, San Diego. The principal investigator is Christopher N Schmickl, MD, PhD at University of California, San Diego. The trial plans to enroll 60 participants.