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NCT05804084 · ClinicalTrials.gov registry record · Phase 2
Patient-centered and Neurocognitive Outcomes with Acetazolamide for Sleep Apnea
A Phase 2 study of Obstructive Sleep Apnea, sponsored by University of California, San Diego.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT05804084: Recruiting Phase 2 study of Obstructive Sleep Apnea, sponsored by University of California, San Diego.
NCT05804084 is a Phase 2 study of Obstructive Sleep Apnea that is actively recruiting participants, run by University of California, San Diego. The registered enrollment target is 60 participants, below the 221-participant average among 155 other Obstructive Sleep Apnea trials with a reported enrollment target (73% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05804084, a Phase 2 study of Obstructive Sleep Apnea, is actively recruiting participants, sponsored by University of California, San Diego.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
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, memory problems and can severely affect quality of life. 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. 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. Further, its low cost (66¢/day) and once-daily dosing may be attractive for OSA patients unable or unwilling to wear a mask each night. But previous studies had many limitations such as studying acetazolamide for only a few days and not capturing important outcomes. The goal of this study is to test if acetazolamide can improve sleep apnea, neurocognitive function and quality of life in adults with OSA, and to assess how it does that. Thus, the investigators will treat 60 OSA patients with acetazolamide or placebo for 4 weeks each. The order in which participants receive the drug or placebo will be randomized. At the end of each 4 week period the investigators will assess OSA severity, neurocognitive function and quality of life. 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. Ultimately, this work promises a drug therapy option for millions of OSA patients who are unable to tolerate current treatments
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. Alternative definitions of the AHI will be explored as well (e.g. hypopneas based on 4% desaturations, or position/sleep-stage specific AHIs).
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Acetazolamide
Study Locations (1)
California
- UC San Diego; Altman Clinical and Translational Research Institute Building - La Jolla
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2023-05-16 |
| Est. Completion | 2026-10-31 |
| Phase | Phase 2 |
What NCT05804084 shows while recruiting
NCT05804084 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 221-participant average among 155 other Obstructive Sleep Apnea trials with a reported enrollment target (73% lower).
The record links to 1 condition, with Obstructive Sleep Apnea appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05804084 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT05804084 about?
NCT05804084 is a clinical study titled "Patient-centered and Neurocognitive Outcomes with Acetazolamide for Sleep Apnea". 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 NCT05804084?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2023-05-16. Estimated completion is 2026-10-31.
What conditions does trial NCT05804084 study?
This clinical trial studies the following conditions: Obstructive Sleep Apnea.
What interventions are being tested in trial NCT05804084?
The interventions under investigation include: Placebo (DRUG), Acetazolamide (DRUG).
Who is sponsoring clinical trial NCT05804084?
This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05804084 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05804084's enrollment target sits among peer trials
60 86th of 155 higher than 60 of 155 other Obstructive Sleep Apnea trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Obstructive Sleep Apnea 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.
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