Using acetazolamide to improve obstructive sleep apnea
Acetazolamide as a Means to Mitigate Falling Ventilatory Drive and Drive-dependent OSA
This study is testing if a medication called acetazolamide can help people with obstructive sleep apnea breathe better during sleep.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 21 Years to 80 Years |
| Sex | All |
| Sponsor | Brigham and Women's Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06091085 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 21-80 with suspected or diagnosed obstructive sleep apnea who have not received any OSA treatments in the two weeks prior to the study.
Not a fit: Patients with unstable medical conditions, contraindications to acetazolamide, or those currently using medications that may interfere with the study will not benefit from this trial.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the severity of obstructive sleep apnea and improve quality of life for affected patients.
How similar studies have performed: Previous studies have shown that acetazolamide can reduce the severity of obstructive sleep apnea, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Boston, Massachusetts
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.