NCT06091085 Acetazolamide as a Means to Mitigate Falling Ventilatory Drive and Drive-dependent OSA
| NCT ID | NCT06091085 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Brigham and Women's Hospital |
| Condition | OSA |
| Study Type | INTERVENTIONAL |
| Enrollment | 36 participants |
| Start Date | 2024-01-31 |
| Primary Completion | 2027-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 36 participants in total. It began in 2024-01-31 with a primary completion date of 2027-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Dillon Gilbertson
STUDY DIRECTOR
Brigham and Women's Hospital and Harvard Medical School
Frequently Asked Questions
Who can join the NCT06091085 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 80 Years, studying OSA. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06091085 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06091085 currently recruiting?
Yes, NCT06091085 is actively recruiting participants. Contact the research team at sasands@bwh.harvard.edu for enrollment information.
Where is the NCT06091085 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT06091085 clinical trial?
NCT06091085 is sponsored by Brigham and Women's Hospital. The principal investigator is Dillon Gilbertson at Brigham and Women's Hospital and Harvard Medical School. The trial plans to enroll 36 participants.