Using acetazolamide to improve obstructive sleep apnea

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effects of acetazolamide, a pharmacological ventilatory stimulant, on patients with obstructive sleep apnea (OSA), particularly focusing on those with drive-dependent OSA. The study involves a randomized controlled design where participants will receive either acetazolamide or a placebo over a series of nights, with comprehensive measurements of ventilatory drive and muscle activity to assess treatment efficacy. The trial aims to establish whether acetazolamide can stabilize ventilatory drive and reduce OSA severity, thereby improving patient outcomes. Participants will undergo a baseline sleep study and specialized physiology assessments to confirm eligibility and drive-dependent status.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 for the duration of the study protocol

Exclusion Criteria:

* Any unstable medical condition
* Current use of the study medication.
* Use of ventilatory stimulant or depressant medications that may complicated interpretation of results (including opioids, barbiturates, doxapram, almitrine, theophylline, 4-hydroxybutanoic acid).
* Contraindications for acetazolamide, including:
* Allergies to sulfonamides - e.g. acetazolamide, hydrochlorothiazide, furosemide, sulfasalazine, celecoxib, sumatriptan, and zonisamide.
* closed-angle glaucoma
* adrenal insufficiency
* known electrolyte or acid/base imbalance (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, due to the potential for an interaction of acetazolamide and very high doses of Aspirin (acetylsalicylic acid, a salicylate drug)
* Adrenocortical insufficiency
* Low sodium or potassium
* hyperchloremic acidosis
* Conditions likely to affect obstructive sleep apnea physiology: neuromuscular disease or other major neurological disorder, heart failure, or any other unstable major medical condition.
* Respiratory disorders other than obstructive sleep apnea:
* central sleep apnea (\>75% of respiratory events scored as central)
* chronic hypoventilation/hypoxemia (awake SaO2 \< 92% by oximetry) due to chronic obstructive pulmonary disease or other respiratory conditions
* Conditions likely to increase arousability from sleep: insomnia
* Other sleep disorders that may complicate establishment of sleep: periodic limb movements (periodic limb movement arousal index \> 10/hr), narcolepsy, or parasomnias
* For intramuscular electrodes and catheter: allergy to lidocaine
* Highly-sensitive gag reflex. Patients with a self-reported 'highly-sensitive gag reflex', including an affirmative response to 'Do you sometimes gag when brushing your teeth?', will not take part in the physiology studies given the placement of an esophageal catheter
* For intramuscular electrodes: use of aspirin or other oral anti-platelets / anti-coagulants
* For oronasal mask: severe claustrophobia
* Pregnancy or nursing

Where it's running

• Brigham and Women's Hospital
  Boston, Massachusetts, United States Recruiting

Study contacts

• Principal investigator: Scott Sands, PhD — Brigham and Women's Hospital and Harvard Medical School
• Study coordinator: Scott Sands, PhD
• Email: sasands@bwh.harvard.edu
• Phone: 8579280341

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.