Actively Recruiting
Acetazolamide to Reduce Ventilatory Drive Decline and Treat Drive-dependent Obstructive Sleep Apnea
Led by Brigham and Women's Hospital · Updated on 2024-03-04
36
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Obstructive sleep apnea (OSA) is a common disorder that affects heart health, brain function, daytime alertness, and overall quality of life. Researchers are studying a new model called drive-dependent OSA, which involves unstable breathing control that can sometimes help keep the airway open during sleep. This study aims to see if the drug acetazolamide can improve OSA severity in people with drive-dependent OSA compared to those with classic OSA by stabilizing breathing control during sleep. Participants will receive acetazolamide or a placebo for three nights each in a randomized order, with a half dose on the first night and full doses on the next two nights. After each treatment period, they will stay overnight in a sleep lab for detailed assessments. There is a one-week gap between treatments. Following this, a four-week open-label extension will check if acetazolamide's effects continue with repeated use without invasive testing. Throughout the study, participants will take part in sleep studies that measure breathing, muscle activity, and brain arousals. These include routine and specialized sleep tests with advanced monitoring of breathing drive and airway muscle function. Researchers will track changes in apnea events, oxygen levels, and sleep quality, and carefully record any side effects. The total participation includes screening, two treatment periods, and a month-long extension to evaluate ongoing effects and symptoms.
CONDITIONS
Brief Title
Acetazolamide as a Means to Mitigate Falling Ventilatory Drive and Drive-dependent OSA
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ages 21 to 80 years
- Suspected or diagnosed obstructive sleep apnea (OSA)
- No use of OSA treatments within 2 weeks before baseline
- No plans to start OSA treatments during the study
You will not qualify if you...
- Any unstable medical condition
- Current use of acetazolamide or study medication
- Use of medications affecting breathing such as opioids or barbiturates
- Allergies to sulfonamide drugs (e.g., acetazolamide, hydrochlorothiazide)
- Closed-angle glaucoma
- Adrenal insufficiency
- Known electrolyte or acid/base imbalances
- Significant kidney or liver disorders
- Use of more than 500 mg/day aspirin
- Conditions affecting OSA physiology like neuromuscular disease or heart failure
- Respiratory disorders other than OSA, including central sleep apnea
- Insomnia or other sleep disorders complicating sleep assessment
- Allergy to lidocaine for catheter procedures
- Highly sensitive gag reflex
- Use of aspirin or blood thinners for electrode procedures
- Severe claustrophobia affecting mask use
- Pregnancy or nursing
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 virtual visit (video call) for screening and consent
Duration - Up to 2 weeks
Participants attend routine and specialized sleep studies to confirm eligibility and establish baseline ventilatory and muscle activity measurements.
2 visits (in-person) for routine sleep study and specialized physiology night
Duration - Approximately 3 weeks including a 4-day washout between treatments
Participants receive acetazolamide and placebo in randomized order, each administered for 3 nights with a half-dose on the first night followed by full doses on subsequent nights.
2 treatment periods with 1 in-person visit on the 3rd night of each period for outcomes data collection
Duration - 4 weeks
Participants receive repeated doses of acetazolamide for 4 weeks without invasive measurements to assess short-term efficacy and symptom changes.
Visits as needed using routine sleep equipment, visit schedule may vary
Trial Site Locations
Total: 1 location
1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02141
Actively Recruiting
Research Team
S
Scott Sands, PhD
A
Atqiya Aishah, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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