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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 night

Awards & highlights

Study 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.Check my eligibility

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.See study design

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 below

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I either suspect I have sleep apnea or have been diagnosed with it.

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I am between 21 and 80 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 night

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 night

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 night for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

Arousal index, events/hr

Hypoxic burden, %.min/hr

N1 sleep, %total sleep time

Side effects data

From 2022 Phase 4 trial • 11 Patients • NCT03377049

External Ventricular Drainage infection

Hydrocephalus

Pulmonary edema

Cardiomyopathy

100%

80%

60%

40%

20%

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

~2910

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor

1,616 Previous Clinical Trials

11,470,912 Total Patients Enrolled

Scott Sands, PhDPrincipal InvestigatorBrigham and Women's Hospital and Harvard Medical School

1 Previous Clinical Trials

36 Total Patients Enrolled

Dillon GilbertsonStudy DirectorBrigham and Women's Hospital and Harvard Medical School

2 Previous Clinical Trials

61 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this medical trial permit participants aged 45 or older?

"This particular clinical trial is only accepting individuals aged 21 to 80. If an individual falls outside of this age range, there are 23 trials for those under 18 and 144 for those above 65."

Answered by AI

Could I potentially join this clinical experiment?

"This sleep apnea study is admitting up to 36 patients between the ages of 21 and 80. To be eligible, a person must have been diagnosed with obstructive sleep apnea."

Answered by AI

Is this research experiment accepting new participants?

"According to the clinicaltrials.gov information, this particular research endeavour is not presently recruiting new patients for participation. The trial was first posted on November 1st 2023 and saw its most recent update on October 16th 2023. Fortunately, there are 171 other studies that require participants at this current juncture in time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Scott Aaron Sands 2024. "Acetazolamide as a Means to Mitigate Falling Ventilatory Drive and Drive-dependent OSA". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06091085.