What side effects are associated with this type of intervention?

Common treatments for Obstructive Sleep Apnea (OSA) include Continuous Positive Airway Pressure (CPAP) therapy, mandibular advancement devices, and pharmacotherapy such as acetazolamide. CPAP therapy can cause side effects like nasal congestion, dry mouth, and skin irritation from the mask. Mandibular advancement devices may lead to jaw discomfort, dental issues, and excessive salivation. Acetazolamide, a mild diuretic, is generally well-tolerated but can cause side effects such as frequent urination, tingling in the extremities, and a metallic taste. It is also known to reduce choking during sleep and lower blood pressure, making it a potential alternative for those who cannot tolerate CPAP.

What prior FDA approvals exist?

There are no specific FDA-approved drugs mentioned in the provided context for the treatment of Obstructive Sleep Apnea (OSA). However, acetazolamide, a mild diuretic, has shown promise in reducing choking during sleep and lowering blood pressure in OSA patients. While pharmacotherapy has not been significantly effective for OSA in general, acetazolamide is being studied for its potential benefits, particularly in young adults who may not tolerate traditional treatments like CPAP masks.

What other types of research exist?

Spironolactone has shown promise in reducing the severity of OSA and lowering blood pressure in patients with resistant hypertension and moderate-to-severe OSA. This makes it a potential alternative to Acetazolamide for OSA patients.

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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)

Must not have

Inability to give consent or follow procedures

Other major sleep disorder (e.g., narcolepsy)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 14 days

Summary

This trial tests acetazolamide, a mild diuretic drug, in young adults with obstructive sleep apnea and high blood pressure. The drug aims to improve breathing during sleep and lower blood pressure. Researchers will evaluate its effectiveness for those who struggle with current therapies. Acetazolamide has been investigated for its potential to reduce blood pressure and improve sleep-disordered breathing in patients with hypertension and obstructive sleep apnea.

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am unable to understand or follow the study's procedures.

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I have a major sleep disorder like narcolepsy.

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I am severely allergic to sulfa drugs or am currently taking a carbonic-anhydrase inhibitor.

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My blood tests show low counts or kidney issues.

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I do not have any uncontrolled major health issues.

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My blood pressure is not higher than 160/110mmHg at the start or 180/120mmHg during follow-ups.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

24-hour Mean Blood Pressure

Apnea

Secondary study objectives

24-hour Mean Diastolic Blood Pressure

24-hour Mean Systolic Blood Pressure

Epworth Sleepiness Scale (ESS)

+5 more

Other study objectives

Heart rate

Overnight Memory Improvement (%)

Short Form 36 (SF-36) Health Survey

+1 more

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

Acetazolamide

2011

Completed Phase 4

~3030

Placebo

1995

Completed Phase 3

~2670

Continuous Positive Airway Pressure

2016

Completed Phase 3

~1740

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Obstructive Sleep Apnea (OSA) include Continuous Positive Airway Pressure (CPAP) therapy, which keeps the airway open by providing a constant stream of air through a mask, and oral appliances that reposition the jaw to maintain airway patency. Acetazolamide, a mild diuretic, reduces the apnea-hypopnea index (AHI) by improving respiratory stability and lowering blood pressure. It works by decreasing the body's sensitivity to carbon dioxide, thereby reducing the frequency of apneas and hypopneas. This is particularly beneficial for OSA patients who struggle with CPAP adherence, as it offers a pharmacological alternative that can improve sleep quality and cardiovascular health.

Effect of acetazolamide on susceptibility to central sleep apnea in chronic spinal cord injury.Acetazolamide for OSA and Central Sleep Apnea: A Comprehensive Systematic Review and Meta-Analysis.Efficacy of pharmacotherapy for OSA in adults: A systematic review and network meta-analysis.