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Pharmacological Ventilatory Stimulant
Acetazolamide for Obstructive Sleep Apnea
Phase 1 & 2
Recruiting
Led By Scott Sands, PhD
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Suspected OSA (snoring, sleepiness, witnessed apneas, other clinical symptoms) or diagnosed OSA (severity not required)
Ages 21-80 years
Must not have
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
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 night
Summary
This trial studies whether a drug can help people w/ drive-dependent OSA. It'll test if the drug improves airway obstructions & OSA severity in these individuals.
Who is the study for?
This trial is for adults aged 21-80 with suspected or diagnosed obstructive sleep apnea (OSA) who haven't used OSA treatments in the last two weeks and won't start any during the study. People can't join if they're on certain medications, have allergies to sulfonamides, glaucoma, adrenal or severe kidney/liver issues, electrolyte imbalances, are pregnant/nursing, or have other conditions that might affect results.
What is being tested?
The trial tests whether Acetazolamide can help people with a specific type of OSA by stabilizing their breathing drive compared to a placebo. Participants will be randomly assigned to receive either Acetazolamide or an inactive substance to see if there's an improvement in their condition.
What are the potential side effects?
Acetazolamide may cause side effects like tingling sensations in fingers/toes, taste alterations, frequent urination, drowsiness and confusion. In rare cases it could lead to serious blood disorders or allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I either suspect I have sleep apnea or have been diagnosed with it.
Select...
I am between 21 and 80 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a breathing disorder other than obstructive sleep apnea, like central sleep apnea or chronic hypoventilation.
Select...
I am currently taking the medication being studied.
Select...
I do not have sleep disorders like narcolepsy or frequent limb movements.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 night
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 night
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Percentage reduction of apnea-hypopnea Index (AHI) with active versus placebo therapy in drive-dependent vs classic OSA groups
Secondary study objectives
Arousal index, events/hr
Hypoxic burden, %.min/hr
N1 sleep, %total sleep time
Side effects data
From 2022 Phase 4 trial • 11 Patients • NCT033770499%
External Ventricular Drainage infection
9%
Hydrocephalus
9%
Pulmonary edema
9%
Cardiomyopathy
100%
80%
60%
40%
20%
0%
Study treatment Arm
Acetazolamide Challenge
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: AcetazolamideExperimental Treatment1 Intervention
Acetazolamide administered for 3 nights, half-dose (1 pill) on the first night followed by full dose (2x250mg pills) for 2 nights
Group II: PlaceboPlacebo Group1 Intervention
Placebo sugar pills administered for 3 nights, half-dose (1 pill) on the first night followed by full dose (2 pills) for 2 nights
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Acetazolamide
2011
Completed Phase 4
~3030
Find a Location
Who is running the clinical trial?
Brigham and Women's HospitalLead Sponsor
1,670 Previous Clinical Trials
11,878,230 Total Patients Enrolled
Dillon GilbertsonStudy DirectorBrigham and Women's Hospital and Harvard Medical School
2 Previous Clinical Trials
61 Total Patients Enrolled
Scott Sands, PhDPrincipal InvestigatorBrigham and Women's Hospital and Harvard Medical School
1 Previous Clinical Trials
36 Total Patients Enrolled