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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks
Awards & highlights

PANACEA Trial 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.Check my eligibility
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.See study design
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.

PANACEA Trial 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.

PANACEA Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Apnea Hypopnea Index (AHI)
Secondary outcome measures
Cognitive function composite score
Epworth Sleepiness Scale (ESS) Score
Functional Outcomes of Sleep Questionnaire 10 (FOSQ-10)
+8 more
Other outcome measures
Sleep Apnea Traits with special focus on loop gain

PANACEA 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
Placebo
1995
Completed Phase 3
~2670
Acetazolamide
2011
Completed Phase 4
~2910

Find a Location

Who is running the clinical trial?

University of California, San DiegoLead Sponsor
1,122 Previous Clinical Trials
1,520,984 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,840 Previous Clinical Trials
47,852,064 Total Patients Enrolled
Christopher N Schmickl, MD, PhDPrincipal InvestigatorUniversity of California, San Diego
1 Previous Clinical Trials
50 Total Patients Enrolled

Media Library

Acetazolamide (Diuretic) Clinical Trial Eligibility Overview. Trial Name: NCT05804084 — Phase 2
Obstructive Sleep Apnea Research Study Groups: Placebo, then Acetazolamide, Acetazolamide, then Placebo
Obstructive Sleep Apnea Clinical Trial 2023: Acetazolamide Highlights & Side Effects. Trial Name: NCT05804084 — Phase 2
Acetazolamide (Diuretic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05804084 — Phase 2

Frequently Asked Questions

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

Is it possible to join this experiment at the present time?

"As per information found on clinicaltrials.gov, the initial posting of this trial was made April 15th 2023 and last updated 10 days later - however, it is no longer recruiting patients as of now. However, there are 259 other active studies currently searching for participants."

Answered by AI

Has this therapeutic intervention acquired endorsement from the FDA?

"Our internal rating for the safety of this particular treatment is a 2, as there are no indications of efficacy yet but existing data suggests that it may be safely used."

Answered by AI

Who else is applying?

What site did they apply to?
UC San Diego; Altman Clinical and Translational Research Institute Building
What portion of applicants met pre-screening criteria?
Did not meet criteria

Why did patients apply to this trial?

Improving my health . And hoping trial can help with my loud snoring and Fatigue.
PatientReceived no prior treatments
~40 spots leftby Oct 2026