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Acetazolamide for Drive-Dependent Obstructive Sleep Apnea (OSA)

This study is investigating if a medication called acetazolamide can help people with obstructive sleep apnea (OSA). Researchers believe that a specific type of OSA, called "drive-dependent OSA," might respond better to this treatment. You would receive either acetazolamide or a placebo (a sugar pill) for three nights. The study aims to see if acetazolamide reduces the number of breathing interruptions during sleep (measured by the apnea-hypopnea index, or AHI) more effectively than the placebo, especially in those with drive-dependent OSA. To join, you should be between 21 and 80 years old, have suspected or diagnosed OSA, and not be using other OSA treatments. The study is currently recruiting 36 participants.

Study design
This is a randomized controlled study, meaning participants are randomly assigned to receive either acetazolamide or a placebo. It plans to enroll 36 participants.
What's involved
You would attend a virtual screening and consent visit, followed by a baseline sleep study. You would then have a specialized night of sleep monitoring and take either acetazolamide or placebo for 3 nights.
Compensation
Not stated in the trial record.
Follow-up
The main treatment effect is measured after 1 night. There is also a 4-week open-label extension to explore repeated-dose efficacy.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06091085

Acetazolamide as a Means to Mitigate Falling Ventilatory Drive and Drive-dependent OSA

Recruiting
PHASE1Ages 21–80InterventionalTreatment
Brigham and Women's Hospital
~36 participants
Updated 2024-03-04 on ClinicalTrials.gov
What's tested:AcetazolamidePlacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage reduction of apnea-hypopnea Index (AHI) with active versus placebo therapy in drive-dependent vs classic OSA groups
Measured over 1 night

Conditions

OSA

Explore related trials

Obstructive Sleep Apnea

Where it's being run

1 sites across 1 states
Massachusetts1

Study leadership

  • Dillon Gilbertson · STUDY_DIRECTOR · Brigham and Women's Hospital and Harvard Medical School
  • Scott Sands, PhD · PRINCIPAL_INVESTIGATOR · Brigham and Women's Hospital and Harvard Medical School

Who to contact

Scott Sands, PhD
[email protected]
8579280341
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Percentage reduction of apnea-hypopnea Index (AHI) with active versus placebo therapy in drive-dependent vs classic OSA groups1 night

    The primary efficacy outcome measure is the apnea hypopnea index (3% desaturation or arousal), presented as a percent reduction from baseline. Differences in this measure with active versus placebo therapy will be assessed. The primary comparison will be the difference in this measure in drive-dependent versus classic OSA subgroups.