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NCT04639193 · ClinicalTrials.gov registry record · Phase 2
Combination Drug-Therapy for Patients With Untreated Obstructive Sleep Apnea
A Phase 2 study, sponsored by University of California, San Diego.
- Completed
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
NCT04639193: Completed Phase 2 study, sponsored by University of California, San Diego.
NCT04639193 is a Phase 2 study that has completed, run by University of California, San Diego. The registered enrollment target is 20 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04639193, a Phase 2 study, has completed, sponsored by University of California, San Diego.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
Study Summary
Obstructive sleep apnea (OSA) is common and associated with many adverse health consequences, but many patients are unable to tolerate standard therapies such as continuous positive airway pressure (CPAP) and thus remain untreated. Single-drug therapies have shown promising results in treating sleep apnea, but on average patients have only experienced partial relief. Multi-drug therapy may offer a more effective treatment approach. The goal of this study is to test the effect of combination therapy with three FDA-approved drugs (Diamox \[acetazolamide\], Lunesta \[eszopiclone\] +/- Effexor \[venlafaxine\]) on OSA severity and physiology.
Primary Outcome
The AHI is a measure of sleep apnea severity and based on the American Academy of Sleep Medicine (AASM)-recommended criteria 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. To avoid confounding by sleep stages and positions across study nights the primary focus was on the AHI during supine non rapid eye movement (NREM) sleep. For comparability with other
Interventions
- DRUG Placebo
- DRUG Acetazolamide
- DRUG Eszopiclone
- DRUG Venlafaxine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2020-12-01 |
| Est. Completion | 2022-01-27 |
| Phase | Phase 2 |
What the finished NCT04639193 record still lists
NCT04639193 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT04639193 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04639193 about?
NCT04639193 is a clinical study titled "Combination Drug-Therapy for Patients With Untreated Obstructive Sleep Apnea". Obstructive sleep apnea (OSA) is common and associated with many adverse health consequences, but many patients are unable to tolerate standard therapies such as continuous positive airway pressure (CPAP) and thus remain untreated. Single-drug therapies have shown promising results in treating sleep...
What is the current status of trial NCT04639193?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2020-12-01. Estimated completion is 2022-01-27.
What interventions are being tested in trial NCT04639193?
The interventions under investigation include: Placebo (DRUG), Acetazolamide (DRUG), Eszopiclone (DRUG), Venlafaxine (DRUG).
Who is sponsoring clinical trial NCT04639193?
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 NCT04639193's enrollment target sits among peer trials
20 1805th of 2000 higher than 107 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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