Study of Bexagliflozin to Reduce Sleep Apnea Severity in Adults Who Are Overweight or Obese with Moderate to Severe Obstructive Sleep Apnea

What this Trial Is About

Researchers are evaluating whether bexagliflozin can lower the severity of sleep apnea in adults who are overweight or obese with moderate to severe obstructive sleep apnea OSA. The study aims to see if this drug reduces anatomical and physiological traits linked to OSA and improves clinical measures of sleep apnea and sleep deficiency. Participants will receive either the drug or a placebo, with normal care maintained for six months. Participants are randomly assigned to take either bexagliflozin 20 mg once daily or a matching placebo daily for six months. Both groups will continue their usual clinical care during this period. Measurements are taken at the start and end of the study, including MRI scans to assess fat and airway structures, sleep studies to measure apnea and oxygen levels, blood tests, and other assessments of sleep quality and body composition. Throughout the study, participants will undergo various evaluations such as full ambulatory polysomnography, MRI imaging, blood biomarkers, neck circumference measurements, and questionnaires about sleep quality and daytime sleepiness. These assessments occur at baseline, three months, and six months to monitor changes. The primary outcome measure is the change in the apnea hypopnea index AHI after six months. Safety and adherence will be monitored during the entire study period.

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