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

Launched by BRIGHAM AND WOMEN'S HOSPITAL · Oct 16, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a medication called acetazolamide to see if it can help people with a type of obstructive sleep apnea (OSA) known as "drive-dependent OSA." OSA is a common sleep disorder that can cause breathing interruptions during sleep, leading to health issues like heart problems, daytime sleepiness, and lower quality of life. In this trial, researchers want to find out if acetazolamide can improve breathing stability in people with this specific type of OSA compared to those with more traditional forms of the disorder.

To participate, individuals must be between the ages of 21 and 80 and either have symptoms of OSA (like snoring or excessive sleepiness) or have been diagnosed with it. Importantly, participants should not be currently using any OSA treatments. Throughout the study, participants will be monitored to assess how acetazolamide affects their sleep and breathing. It's worth noting that there are specific health conditions and medications that could prevent someone from joining the trial, so potential participants should discuss their medical history with the study team.

Gender

ALL

Eligibility criteria

• 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