Adipose Dysfunction, Imaging, Physiology, and Outcomes With SGLT2i's for Sleep Apnea: The ADIPOSA Study

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Able to provide informed consent and stated willingness to comply with all study procedures and availability for the duration of the study

• Overweight or obese (body mass index 25-40 kg/m2)

• Clinically confirmed diagnosis of obstructive sleep apnea by one of the following methods:

• a. Polysomnography: AHI ≥15/hour sleep or b. Home sleep apnea testing: Respiratory event index (REI) ≥15/hour sleep

• AHI: apnea-hypopnea index (apneas + hypopneas / total sleep time in hours)

Locations
United States
Connecticut
Yale New Haven Health
RECRUITING
New Haven
Ohio
University Hospitals Cleveland Medical Center
RECRUITING
Cleveland
Contact Information
Primary
Henry K Yaggi, M.D.
henry.yaggi@yale.edu
203-785-4163
Backup
Ian J Neeland, M.D.
Ian.Neeland@UHhospitals.org
216-844-5965
Time Frame
Start Date: 2024-03-27
Estimated Completion Date: 2027-09
Participants
Target number of participants: 164
Treatments
Experimental: Bexagliflozin
Bexagliflozin once daily for 6 months
Placebo_comparator: Placebo
Placebo once daily for 6 months
Related Therapeutic Areas
Sponsors
Leads: Yale University
Collaborators: Case Western Reserve University

This content was sourced from clinicaltrials.gov