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NCT05616260 · ClinicalTrials.gov registry record · Phase 2
Acetazolamide for Obstructive Sleep Apnea to Improve Heart Health
A Phase 2 study, sponsored by University of California, San Diego.
- Completed
- Registry status
- Phase 2
- Development phase
- 54
- Enrollment target
NCT05616260: Completed Phase 2 study, sponsored by University of California, San Diego.
NCT05616260 is a Phase 2 study that has completed, run by University of California, San Diego. The registered enrollment target is 54 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (59% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05616260, a Phase 2 study, has completed, sponsored by University of California, San Diego.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 54 participants
- Enrollment target
Study Summary
Obstructive sleep apnea (OSA) is a severe type of snoring causing people to choke in their sleep. It affects millions of Americans, causing many health problems. For example, patients with OSA often feel very sleepy and are at risk of falling asleep while driving. OSA also causes elevated blood pressure increasing the risk for heart attacks and strokes. Patients with OSA are often treated with a face-mask that helps them breath at night but can be difficult to tolerate. In fact, about half the patients eventually stop using this mask. Because there are few other treatments (and no drug therapy), many OSA patients are still untreated. Of note, especially young adults (i.e. 18 to 50 years old) benefit from treating their OSA, but they are also less likely to use the mask. Acetazolamide (a mild diuretic drug) has been used for over 50 years to treat many different conditions and is well tolerated. Recent data suggest, that acetazolamide may help OSA patients to not choke in their sleep and lower their blood pressure. Especially young adults with OSA are likely to respond well to this drug. Further, its low cost (66¢/day) and once- daily dosing may be particularly attractive for young OSA patients unable or unwilling to wear a mask each night. But previous studies had many limitations and did not focus on young adults. The goal of this study is to test if acetazolamide can improve sleep apnea and cardiovascular health in young adults with OSA (18-50 years old), and how it does that. Thus, we will treat 46 young OSA patients with acetazolamide or placebo for 2 weeks each. The order in which participants receive the drug or placebo will be randomized. At the end of each 2 week period we will assess OSA severity and cardiovascular health. Thus, this study will help assess acetazolamide's potential value for OSA treatment, and may also help to identify patients who are most likely to respond to acetazolamide (including select individuals \>50 years of age). Ultimately, th
Primary Outcome
The AHI is a measure of sleep apnea severity and is defined as the number of apneas (no breathing for 10+ seconds) and hypopneas (reduced breathing for 10+ seconds associated with a \>=3% desaturation or cortical arousal) per hour of sleep.
Interventions
- DRUG Placebo
- DRUG Acetazolamide
- DEVICE Continuous Positive Airway Pressure
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2022-12-02 |
| Est. Completion | 2025-05-13 |
| Phase | Phase 2 |
What the finished NCT05616260 record still lists
NCT05616260 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 54 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (59% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT05616260 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05616260 about?
NCT05616260 is a clinical study titled "Acetazolamide for Obstructive Sleep Apnea to Improve Heart Health". Obstructive sleep apnea (OSA) is a severe type of snoring causing people to choke in their sleep. It affects millions of Americans, causing many health problems. For example, patients with OSA often feel very sleepy and are at risk of falling asleep while driving. OSA also causes elevated blood pres...
What is the current status of trial NCT05616260?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 54 participants. The study started on 2022-12-02. Estimated completion is 2025-05-13.
What interventions are being tested in trial NCT05616260?
The interventions under investigation include: Placebo (DRUG), Acetazolamide (DRUG), Continuous Positive Airway Pressure (DEVICE).
Who is sponsoring clinical trial NCT05616260?
This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05616260's enrollment target sits among peer trials
54 1160th of 2000 higher than 830 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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