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.
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)
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
Parallel
Bexagliflozin 20 mg
Drug15mg once daily
Placebo
Drugmatching placebo once daily
Change in Apnea hypopnea index (AHI) measured by full ambulatory polysomnography (aPSG)
All participants will undergo a full in-home aPSG with a Nox-A1 system, which collects sleep EEG required to determine the physiologic traits and measures of sleep apnea. This is an unattended sleep monitor. The AHI is the number of apneas or hypopneas recorded during the sleep study per hour of sleep. Higher AHI indicates the severity of sleep apnea.
Change in Neck and body fat and lean volume by MRI
Participants will undergo standard measurements including height, weight, waist circumference, hip circumference, and neck circumference by MRI to quantify fat and lean tissue composition in the neck and body. Volumetric imaging datasets of the body will be derived by MRI using validated and readily available protocols with rapid scan time to perform precise measurements of total and regional body composition to quantify fat and lean tissue composition in the neck and body. MRI imaging using a 6-minute dual-echo Dixon Vibe protocol, providing water and fat separated volumetric data set covering neck to knees, and a single-slice multi-echo Dixon acquisition for proton density fat fraction (PDFF) assessment in the liver.
Change in Airway caliber by MRI
Volumetric imaging datasets of the body derived by MRI using validated and readily available protocols with rapid scan time to perform precise measurements of total and regional body composition to quantify fat and lean tissue composition in the neck and body, including MRI imaging using a 6-minute dual-echo Dixon Vibe protocol, providing water and fat separated volumetric data set covering neck to knees, and a single-slice multi-echo Dixon acquisition for proton density fat fraction (PDFF) assessment in the liver.
Change in Critical closing pressure (Pcrit)/normal ventilatory drive (Vpass) by aPSG
Mathematical modeling to determine the patient's ventilatory drive in response to changes in ventilation induced by upper airway obstruction (i.e., apnea/hypopnea). Pharyngeal collapsibility, calculated as the level of ventilation during sleep at normal or eupneic ventilatory drive (Vpassive) and is a valid proxy for critical closing pressure (Pcrit) and a reflection of the impact of the anatomic traits of sleep apnea.
Change in neck circumference
Change in neck circumference measured by tape measure. Measuring the change in the evening to morning neck circumference which is a validated measure of caudal to rostral fluid shift. Higher neck circumference indicates an increase in probability of sleep apnea.
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Yale University
Lead sponsor
Case Western Reserve University
Collaborator
