Adipose Dysfunction, Imaging, Physiology, and Outcomes With Sodium Glucose Cotransporter 2 Inhibitor (SGLT2i) for Sleep Apnea: The ADIPOSA Study

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT05612594
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bexagliflozin 20 mg — DRUG
    15mg once daily
  • Placebo — DRUG
    matching placebo once daily

Study Details

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.

Key Dates

Start date
Mar 27, 2024
Status verified
Sep 2025
Primary completion
Sep 30, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
164 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Bexagliflozin
    Bexagliflozin once daily for 6 months
  • Placebo Comparator: Placebo
    Placebo once daily for 6 months

Primary Outcome Measure

Change in Apnea hypopnea index (AHI) measured by full ambulatory polysomnography (aPSG) [ Time Frame: Baseline and 6 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Yale New Haven HealthNew HavenConnecticut06520-
University Hospitals Cleveland Medical CenterClevelandOhio44106-

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By research site
Yale New Haven Health· New Haven, CTUniversity Hospitals Cleveland Medical Center· Cleveland, OH

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