Actively Recruiting

Phase 1
Phase 2
Age: 21Years - 80Years
All Genders
NCT06091085

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

Age: 21Years - 80Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Brigham and Women's Hospital

Boston, Massachusetts, United States, 02141

Actively Recruiting

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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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