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New treatment option for Sleep Apnea
Official title Adipose Dysfunction, Imaging, Physiology, and Outcomes With Sodium Glucose Cotransporter 2 Inhibitor (SGLT2i) for Sleep Apnea: The ADIPOSA Study
ClinicalTrials.gov ID: NCT05612594
What this study is testing
What is Bexagliflozin 20 mg?
Bexagliflozin 20 mg is an investigational medicine, given as an once-daily, being studied as a potential treatment for sleep apnea.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- AHI: apnea-hypopnea index (apneas + hypopneas / total sleep time in hours)
You likely can't join if
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Known non-OSA related conditions associated with sleep disordered breathing (e.g., central disorder of hypersomnolence, neurological, neuromuscular...
- Use of sleep-inducing medications (e.g. benzodiazepines, opiates, barbiturates)
- Type 1 diabetes mellitus
- History of diabetic ketoacidosis
- Known hypersensitivity reaction to bexagliflozin or any of its constituents or any contraindication to bexagliflozin use
See the full eligibility 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)
- An individual who meets any of the following criteria will be excluded from participation in this study:
- 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 bexagliflozin or any of its constituents or any contraindication to bexagliflozin use
- Severe, recurrent urinary tract or genital mycotic infections
- eGFR\<30mL/min/1.73m2 at time of or within 4 weeks of enrollment in the study
- 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.
- Currently or planning to take a SGLT2i prior to or during enrollment in the study
- Currently or planning to follow a ketogenic diet pattern ("keto diet) prior to or during enrollment in the study
- Currently or planning to follow an active weight loss program (including but not limited to use of supplements, medications, or surgery) prior to or during enrollment in the study
- Currently or planning to follow an intermittent fasting diet plan prior to or during enrollment in the study
- Currently or planning to take a GLP-1 receptor agonist prior to or during enrollment in the study .
- Existing lower limb ulcer (due to diabetes or any cause)
- Existing severe peripheral arterial disease with intermittent claudication and/or prior lower limb revascularization procedure
- Concomitant administration of UGT inducers
- Severe liver disease
The study team makes the final eligibility decision.
Where it's taking place
- New Haven, Connecticut, United States
- Cleveland, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Haven, Connecticut, United States; Cleveland, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.