Adipose Dysfunction, Imaging, Physiology, and Outcomes With SGLT2i's for Sleep Apnea: The ADIPOSA Study
Yale University
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.
Description
The primary objective of this study is to determine whether bexagliflozin 20 mg once daily compared with placebo reduces the apnea hypopnea index (AHI) in adults with overweight or obesity with moderate to severe OSA. The secondary objectives of this study are to determine whether bexagliflozin 20 mg once daily compared with placebo (a look-alike substance that contains no active drug): * reduces visceral and neck fat and upper airway soft tissue structure volumes and increases airway caliber * reduces Critical closing pressure * reduces rostral to caudal fluid shifts (measured by neck circu…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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) Exclusion Criteria: An individual who meets any of the following criteria will be excluded from…
Interventions
- DrugBexagliflozin 20 mg
15mg once daily
- DrugPlacebo
matching placebo once daily
Locations (2)
- Yale New Haven HealthNew Haven, Connecticut
- University Hospitals Cleveland Medical CenterCleveland, Ohio