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

• Status: Not yet recruiting
• Trial end date: 2027-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The goal of this clinical trial is to test if ertugliflozin 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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yale University
• Collaborator: Case Western Reserve University
• Treatments: Ertugliflozin

Criteria

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:

• 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

• Known hypersensitivity reaction to ertugliflozin or any of its constituents or any contraindication to ertugliflozin use

• Severe, recurrent urinary tract or genital mycotic infections

• Plan to initiate glucagon-like peptide 1 (GLP-1) receptor agonist therapy for weight loss or glycemic control in the next 6 months

• Unable to complete/tolerate magnetic resonance imaging (MRI) due to severe claustrophobia or metallic implants.

• Language barrier, mental incapacity, unwillingness or inability to understand.

• Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant.