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Diuretic

Acetazolamide for Obstructive Sleep Apnea (ACE-Of-HEARTs Trial)

Phase 2

Recruiting

Led By Christopher Schmickl, MD, PhD

Research Sponsored by University of California, San Diego

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18 to 50 years

Untreated OSA (AHI ≥10/h)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 14 days

Awards & highlights

ACE-Of-HEARTs Trial Summary

This trial will study if a mild diuretic drug, acetazolamide, can improve sleep apnea & cardiovascular health in young adults, offering an alternative treatment for millions of OSA patients who are unable to tolerate current treatments.

Who is the study for?

This trial is for young adults aged 18-50 with untreated obstructive sleep apnea (OSA), a body mass index ≤35, and abnormal blood pressure. It's not for those allergic to sulfa-drugs, using certain medications, abusing substances, or with severe health issues like uncontrolled hypertension or major organ disorders.Check my eligibility

What is being tested?

The study tests if acetazolamide can improve OSA and heart health in young adults. Participants will be randomly given either the drug or a placebo for two weeks each, with assessments of OSA severity and cardiovascular health after each period.See study design

What are the potential side effects?

Acetazolamide may cause side effects such as increased urination due to its diuretic effect, tingling in fingers/toes, drowsiness, confusion, and potential allergic reactions in those sensitive to sulfa drugs.

ACE-Of-HEARTs Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 50 years old.

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I have untreated sleep apnea with an AHI of 10 or more.

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My blood pressure is high or I've been on stable blood pressure medication for over a month.

ACE-Of-HEARTs Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 14 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~14 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 14 days for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

24-hour Mean Blood Pressure

Apnea

Secondary outcome measures

24-hour Mean Diastolic Blood Pressure

24-hour Mean Systolic Blood Pressure

Epworth Sleepiness Scale (ESS)

+5 more

Other outcome measures

Heart rate

Overnight Memory Improvement (%)

Short Form 36 (SF-36) Health Survey

+1 more

ACE-Of-HEARTs Trial Design

2Treatment groups

Experimental Treatment

Group I: Placebo, then Acetazolamide, then optional open-label CPAP-therapyExperimental Treatment3 Interventions

Subjects will start with a 2-week PLACEBO regimen Day 1-13: Placebo (matching Acetazolamide 500mg) at bedtime at home Day 14: Placebo (matching Acetazolamide 500mg) at bedtime in the sleep laboratory After a wash-out period, subjects will then cross-over to a 2-week ACETAZOLAMIDE regimen: Day 1-13: Acetazolamide 500mg at bedtime at home Day 14: Acetazolamide 500mg at bedtime in the sleep laboratory After a wash-out period, subjects may then undergo an OPTIONAL, OPEN-LABEL 2-week CPAP regimen: - Day 1-14: CPAP will be used at home during sleep

Group II: Acetazolamide, then Placebo, then optional open-label CPAP-therapyExperimental Treatment3 Interventions

Subjects will start with a 2-week ACETAZOLAMIDE regimen Day 1-13: Acetazolamide 500mg at bedtime at home Day 14: Acetazolamide 500mg at bedtime in the sleep laboratory After a wash-out period, subjects will then cross-over to a 2-week PLACEBO regimen: Day 1-13: Placebo (matching Acetazolamide 500mg) at bedtime at home Day 14: Placebo (matching Acetazolamide 500mg) at bedtime in the sleep laboratory After a wash-out period, subjects may then undergo an OPTIONAL, OPEN-LABEL 2-week CPAP regimen: - Day 1-14: CPAP will be used at home during sleep

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Continuous Positive Airway Pressure

2016

Completed Phase 3

~1680

Acetazolamide

2011

Completed Phase 4

~2910

Placebo

1995

Completed Phase 3

~2670

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of California, San DiegoLead Sponsor

1,121 Previous Clinical Trials

1,520,878 Total Patients Enrolled

Christopher Schmickl, MD, PhDPrincipal InvestigatorUniversity of California, San Diego

1 Previous Clinical Trials

20 Total Patients Enrolled

Media Library

Acetazolamide (Diuretic) Clinical Trial Eligibility Overview. Trial Name: NCT05616260 — Phase 2

Obstructive Sleep Apnea Research Study Groups: Placebo, then Acetazolamide, then optional open-label CPAP-therapy, Acetazolamide, then Placebo, then optional open-label CPAP-therapy

Obstructive Sleep Apnea Clinical Trial 2023: Acetazolamide Highlights & Side Effects. Trial Name: NCT05616260 — Phase 2

Acetazolamide (Diuretic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05616260 — Phase 2

Frequently Asked Questions

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

What criteria is necessary to qualify for this research program?

"Candidates satisfying the criteria of 18-50 years old and having been diagnosed with obstructive sleep apnea (OSA) may be approved for this study. The trial is presently enrolling around 46 participants."

Answered by AI

Could this treatment prove detrimental to the wellbeing of participants?

"The safety of this therapeutic intervention has been evaluated and deemed a 2, as the trial is in Phase 2; which suggests that there are some data supporting its security but none demonstrating its utility."

Answered by AI

What are the purposes of this investigation?

"Over a two-week period, the researchers aim to track and assess Apnea Hypopnea Index (AHI) as well as measure sleep disturbance using Patient-Reported Outcomes Measurement Information System's Sleep Disturbance Assessment scale with T-scores indicating levels of disruption. Additionally, they will evaluate Sleep Related Impairment (SRI) via PROMIS 8 item instrument also scored on T-scale for comparative analysis against baseline values in US general population. Lastly, Epworth Sleepiness Scale is used to gauge likelihood of dozing off in various scenarios ranging from 0 to 3 points per activity summed up for an overall"

Answered by AI

Is this research enrolling senior citizens?

"This trial is limited to individuals aged 18-50 years old. On the other hand, 48 medical studies are available for minors and 237 research opportunities exist for those over 65."

Answered by AI

Are there any opportunities to join this experiment?

"Per the information posted on clinicaltrials.gov, this investigation is no longer recruiting individuals as it was last updated on November 14th 2022. However, 293 other studies are currently searching for volunteers to partake in them."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Acetazolamide for Obstructive Sleep Apnea to Improve Heart Health

Christopher Schmickl 2022. "Acetazolamide for Obstructive Sleep Apnea to Improve Heart Health". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05616260.

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