Patient-centered and Neurocognitive Outcomes With Acetazolamide for Sleep Apnea

• Status: Not yet recruiting
• Trial end date: 2027-08-31
• Target enrollment: 0
• Participant gender: All

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, we 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 we 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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, San Diego
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI)
• Treatments: Acetazolamide

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