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NCT05612594
Adipose Dysfunction, Imaging, Physiology, and Outcomes With Sodium Glucose Cotransporter 2 Inhibitor (SGLT2i) for Sleep Apnea: The ADIPOSA Study
Conditions: Sleep Apnea
Sex: All
Ages: 18 Years – N/A
Phase: PHASE4
Enrollment: 164
Sponsor: Yale University
Location: United States
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 participantsIf 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
Inclusion Criteria:Able to provide informed consent and stated willingness to comply with all study procedures and availability for the duration of the studyOverweight 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 sleepAHI: 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 mellitusHistory of diabetic ketoacidosisKnown hypersensitivity reaction to ertugliflozin or any of its constituents or any contraindication to ertugliflozin useSevere, recurrent urinary tract or genital mycotic infectionsPlan to initiate glucagon-like peptide 1 (GLP-1) receptor agonist therapy for weight loss or glycemic control in the next 6 monthsUnable 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.
Source: ClinicalTrials.gov (NCT05612594). StuddyBuddy aggregates publicly available trial information.