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Diuretic

Acetazolamide for Sleep Apnea (PANACEA Trial)

Phase 2

Recruiting

Led By Christopher N 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 years

Untreated moderate/severe OSA (AHI ≥15/h)

Must not have

Inability to give consent or follow procedures

Significant, uncontrolled cardiac, pulmonary, endocrine, renal, hepatic, neurocognitive, psychiatric, or urologic (e.g., kidney stones) disorder

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 weeks

Summary

This trial hopes to test if a drug, acetazolamide, can help improve sleep apnea, neurocognitive function and quality of life in OSA patients. It may also help identify patients most likely to benefit from the drug.

Who is the study for?

Adults over 18 with a BMI ≤ 35 kg/m2 and untreated moderate/severe obstructive sleep apnea (AHI ≥15/h) can join. Excluded are those using OSA therapy in the last month, with severe sleep hypoxemia, other major sleep disorders, significant health issues, sulfa-drug allergies, abnormal blood counts or renal function, pregnant/breastfeeding women, prisoners, certain medication users or heavy drinkers.

What is being tested?

The trial is testing if Acetazolamide improves obstructive sleep apnea symptoms and quality of life compared to a placebo. Participants will be randomly assigned to receive either the drug or placebo for four weeks each and then switch. The effects on OSA severity and neurocognitive function will be measured after each period.

What are the potential side effects?

Acetazolamide may cause side effects like tingling sensations in fingers/toes, diuresis (increased urine production), drowsiness, confusion; less commonly it might lead to metabolic disturbances such as altered blood electrolyte levels.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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I have severe sleep apnea not yet treated.

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 do not have any uncontrolled major health issues.

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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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Apnea Hypopnea Index (AHI)

Secondary study objectives

Cognitive function composite score

Epworth Sleepiness Scale (ESS) Score

Functional Outcomes of Sleep Questionnaire 10 (FOSQ-10)

+8 more

Other study objectives

Sleep Apnea Traits with special focus on loop gain

Trial Design

2Treatment groups

Experimental Treatment

Group I: Placebo, then AcetazolamideExperimental Treatment2 Interventions

Subjects will start with a 4-week PLACEBO regimen Day 1-27: Placebo (matching Acetazolamide 500mg) at bedtime at home Day 28: Placebo (matching Acetazolamide 500mg) at bedtime in the sleep laboratory After a wash-out period, subjects will then cross-over to a 4-week ACETAZOLAMIDE regimen: Day 1-27: Acetazolamide 500mg at bedtime at home Day 28: Acetazolamide 500mg at bedtime in the sleep laboratory

Group II: Acetazolamide, then PlaceboExperimental Treatment2 Interventions

Subjects will start with a 4-week ACETAZOLAMIDE regimen Day 1-27: Acetazolamide 500mg at bedtime at home Day 28: Acetazolamide 500mg at bedtime in the sleep laboratory After a wash-out period, subjects will then cross-over to a 4-week PLACEBO regimen: Day 1-27: Placebo (matching Acetazolamide 500mg) at bedtime at home Day 28: Placebo (matching Acetazolamide 500mg) at bedtime in the sleep laboratory

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