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

ConditionSleep Apnea
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorYale University

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

164 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Yale University

Lead sponsor

Case Western Reserve University

Collaborator