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NCT05612594 · ClinicalTrials.gov registry record · Phase 4
Adipose Dysfunction, Imaging, Physiology, and Outcomes With Sodium Glucose Cotransporter 2 Inhibitor (SGLT2i) for Sleep Apnea: The ADIPOSA Study
A Phase 4 study of Sleep Apnea, sponsored by Yale University.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 164
- Enrollment target
- 2
- Study locations
NCT05612594: Recruiting Phase 4 study of Sleep Apnea, sponsored by Yale University.
NCT05612594 is a Phase 4 study of Sleep Apnea that is actively recruiting participants, run by Yale University. The registered enrollment target is 164 participants, below the 2,985-participant average among 36 other Sleep Apnea trials with a reported enrollment target (95% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05612594, a Phase 4 study of Sleep Apnea, is actively recruiting participants, sponsored by Yale University.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 164 participants
- Enrollment target
- 2
- Study locations
Study Summary
The goal of this clinical trial is to test if bexagliflozin lowers the sleep apnea severity in adults who are overweight or obese with moderate to severe obstructive sleep apnea (OSA) compared with a placebo (look-alike substance that contains no active drug). The main question it aims to answer is: * If SGLT2i will reduce anatomic and physiologic traits, clinical measures of OSA and sleep deficiency in participants * If improvement in clinical measures are because of improvement in the anatomic and physiologic traits. Participants will be placed on either drug or placebo and get routine normal care for 6 months. At the start and end of the study, participants will undergo different clinical measurements to see if the drug makes the sleep apnea better.
Primary Outcome
All participants will undergo a full in-home aPSG with a Nox-A1 system, which collects sleep EEG required to determine the physiologic traits and measures of sleep apnea. This is an unattended sleep monitor. The AHI is the number of apneas or hypopneas recorded during the sleep study per hour of sleep. Higher AHI indicates the severity of sleep apnea.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Bexagliflozin 20 mg
Study Locations (2)
Connecticut
- Yale New Haven Health - New Haven
Ohio
- University Hospitals Cleveland Medical Center - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 164 participants |
| Start Date | 2024-03-27 |
| Est. Completion | 2027-09 |
| Phase | Phase 4 |
What NCT05612594 shows while recruiting
NCT05612594 is an interventional study that assigns participants to a tested intervention. The registered 164 participants enrollment target is mid-sized for trials with a published cap, below the 2,985-participant average among 36 other Sleep Apnea trials with a reported enrollment target (95% lower).
The record links to 1 condition, with Sleep Apnea appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05612594 reports a single indexed study location in Connecticut, Ohio.
Frequently Asked Questions
What is clinical trial NCT05612594 about?
NCT05612594 is a clinical study titled "Adipose Dysfunction, Imaging, Physiology, and Outcomes With Sodium Glucose Cotransporter 2 Inhibitor (SGLT2i) for Sleep Apnea: The ADIPOSA Study". The goal of this clinical trial is to test if bexagliflozin lowers the sleep apnea severity in adults who are overweight or obese with moderate to severe obstructive sleep apnea (OSA) compared with a placebo (look-alike substance that contains no active drug). The main question it aims to answer is...
What is the current status of trial NCT05612594?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 164 participants. The study started on 2024-03-27. Estimated completion is 2027-09.
What conditions does trial NCT05612594 study?
This clinical trial studies the following conditions: Sleep Apnea.
What interventions are being tested in trial NCT05612594?
The interventions under investigation include: Placebo (DRUG), Bexagliflozin 20 mg (DRUG).
Who is sponsoring clinical trial NCT05612594?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05612594 being conducted?
This trial has 2 study locations across Connecticut, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Sleep Apnea
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 NCT05612594's enrollment target sits among peer trials
164 12th of 36 higher than 25 of 36 other Sleep Apnea trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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