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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 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.

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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.

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

FieldValue
Enrollment Target 164 participants
Start Date 2024-03-27
Est. Completion 2027-09
Phase Phase 4

Sponsor

Yale University

1,492 total trials

What the Registry Record Tells You About NCT05612594

The ClinicalTrials.gov registry entry for NCT05612594 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 164 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,985-participant average among 36 other Sleep Apnea trials with a reported enrollment target (95% lower). The listed sponsor is Yale University, which has 1,492 total studies on file at ClinicalTrials.gov.

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 2 study locations spanning 2 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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