About this trial
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 criteria
Qualifiers
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)
AHI: apnea-hypopnea index (apneas + hypopneas / total sleep time in hours)
Disqualifiers
Known non-OSA related conditions associated with sleep disordered breathing (e.g., central disorder of hypersomnolence, neurological, neuromuscular, or pulmonary disorder)
Use of sleep-inducing medications (e.g. benzodiazepines, opiates, barbiturates)
Type 1 diabetes mellitus
History of diabetic ketoacidosis
Trial design
Treatments tested in this trial
- Bexagliflozin 20 mg
- Placebo
Treatment groups
Sponsors and collaborators
Yale University
Lead sponsor
Case Western Reserve University
Collaborator