NCT05589792

Acetazolamide on REM OSA

The Effect of Acetazolamide on the Severity of REM Obstructive Sleep Apnea

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Brigham and Women's Hospital · Academic / Other
• Sex: All
• Age: 21 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

OSA is a highly prevalent disorder that has major consequences for cardiovascular health, neurocognitive function, risk of traffic accidents, daytime sleepiness and quality of life. In particular, REM sleep is accompanied by more frequent and longer obstructive events, that yield more profound hypoxemia than during non-REM (nREM). Exaggerated OSA severity in REM is the consequence of ventilatory drive dips, particularly during phasic eye movements. Unfortunately, the leading treatment for REM and nREM OSA, CPAP-which acts to pneumatically splint the pharynx open-is intolerable for many patients. Treatment outcomes for REM OSA are burdened by further incomplete CPAP adherence later in the night, which commonly leaves REM periods undertreated. In this protocol, the investigators will test the effect of Acetazolamide on REM OSA and on ventilatory parameters such as genioglossus muscle activity and ventilatory drive.

Detailed description

After a baseline home sleep test that will assess the presence of OSA and REM OSA, two overnight, in-lab sleep studies will be performed: a drug night and a placebo night. The patient will breath spontaneously (without CPAP) for both nights. On the study nights, subjects will present to the laboratory in the evening and be instrumented with a full polysomnigraphy for monitoring sleep, physiological variables (endotypes), and respiratory events. Participants will also be instrumented with EMG wires and introesophageal catheter for the recording of genioglossus muscle activity and respiratory drive, respectively. A history and physical examination will be performed on each night prior to beginning the study, as will a urine pregnancy test in premenopausal women. Acetazolamide 500 mg will be taken for 2 days (including the day of the study), after a day in which it will be administered at half dose, before bedtime. Subjects will sleep at least 50% of the night in the supine position. At least four hours of sleep with high quality signal acquisition will be required for a study to be judged adequate. Subjective sleep quality will be assessed in the morning. After the first overnight study is completed, there will be a four day washout period prior to crossing over to the other treatment

Conditions

• Obstructive Sleep Apnea

Interventions

Type	Name	Description
DRUG	Placebo oral capsule	Placebo before sleep for 3 nights before the study (inclusive)
DRUG	Acetazolamide	Acetazolamide 250 mg 3 nights before the study at bedtime, Acetazolamide 500 mg for 2 nights before the study (inclusive) at bedtime.

Timeline

• Start date: 2023-01-30
• Primary completion: 2025-12-01
• Completion: 2025-12-31
• First posted: 2022-10-21
• Last updated: 2026-01-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study