Actively Recruiting
Acetazolamide as a Means to Mitigate Falling Ventilatory Drive and Drive-dependent OSA
Led by Brigham and Women's Hospital · Updated on 2024-03-04
36
Participants Needed
1
Research Sites
204 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Obstructive sleep apnea (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. For years, a "classic" model of OSA has been used to describe the disorder, which fails to capture it's complexity. Recently, a model for OSA called drive-dependent OSA was discovered be more prevalent in the OSA population. This drive-dependent OSA is due to ventilation instability that occurs during respiratory events however these individuals have spontaneous increases in drive during respiratory events that stabilize their airway (i.e., via improving upper airway muscle activity) and reduce the risk of respiratory events in people with OSA. Therefore, by stabilizing the ventilatory drive, OSA should be treatable. Acetazolamide is a pharmacological ventilatory stimulant and has been previously shown to reduce OSA severity. As such in this study, the goal is to demonstrate acetazolamide improves OSA severity in 'drive-dependent' OSA people by improving drive-related pharyngeal obstructions compared to the 'classic' OSA people.
CONDITIONS
Official 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 21-80 years
- Suspected OSA (snoring, sleepiness, witnessed apneas, other clinical symptoms) or diagnosed OSA (severity not required)
- Untreated; no use of OSA treatments within 2 weeks of the baseline study
- No plans to start OSA treatments during the study protocol
You will not qualify if you...
- Any unstable medical condition
- Current use of the study medication
- Use of ventilatory stimulant or depressant medications that affect study results (e.g., opioids, barbiturates, doxapram, almitrine, theophylline, 4-hydroxybutanoic acid)
- Allergies to sulfonamides (e.g., acetazolamide, hydrochlorothiazide, furosemide, sulfasalazine, celecoxib, sumatriptan, zonisamide)
- Closed-angle glaucoma
- Adrenal insufficiency
- Known electrolyte or acid/base imbalances (hyponatremia, hypokalemia, hyperchloremia, metabolic acidosis, acidemia)
- Clinically significant kidney disorders (eGFR <60 ml/min/1.73m2)
- Clinically significant liver disorders
- Use of more than 500 mg/day of aspirin
- Conditions affecting OSA physiology (neuromuscular disease, major neurological disorders, heart failure, or other unstable major medical conditions)
- Respiratory disorders other than OSA (e.g., central sleep apnea >75% of events, chronic hypoventilation/hypoxemia with awake SaO2 <92%)
- Sleep conditions that increase arousability or complicate sleep (insomnia, periodic limb movements with arousal index >10/hr, narcolepsy, parasomnias)
- Allergy to lidocaine (for intramuscular electrodes and catheter)
- Highly sensitive gag reflex
- Use of aspirin or anticoagulants (for intramuscular electrode placement)
- Severe claustrophobia (for oronasal mask use)
- Pregnancy or nursing
AI-Screening
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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
CONTACT
A
Atqiya Aishah, PhD
CONTACT
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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