Comparing Weight Loss Effects of Endoscopic Sleeve Gastroplasty Plus Lifestyle Changes Versus Lifestyle Changes Alone on Obstructive Sleep Apnea in People with Obesity

What this Trial Is About

Obstructive Sleep Apnea OSA is a condition where breathing repeatedly stops during sleep, often linked to obesity due to extra fat around the neck and throat. This research aims to compare whether Endoscopic Sleeve Gastroplasty ESG, a non-surgical weight-loss procedure, combined with lifestyle changes, improves OSA symptoms better than lifestyle changes alone. The study focuses on people with obesity and moderate to severe OSA to understand how weight loss affects sleep quality and related health issues. The study has two groups one receiving ESG plus a program of diet, exercise, and behavioral therapy, and the other following the same lifestyle program without ESG. ESG involves reducing stomach size using stitches inserted through the mouth under general anesthesia, helping participants feel full sooner and eat less. Both groups follow a low-calorie diet and exercise routine for at least 12 months, with ongoing monitoring of weight loss and sleep apnea. Participants will have regular follow-up visits where their sleep apnea severity is measured using the Apnea-Hypopnea Index AHI and sleep quality questionnaires. Researchers will also track weight changes, metabolic health markers like blood sugar and cholesterol, and any procedure-related side effects. The study will last at least 24 months for some measures, with a primary focus on the improvement in OSA severity one year after treatment. Safety, quality of life, and long-term health impacts will also be evaluated throughout the study.

Effect of Weight Loss From ESG Plus Lifestyle Changes vs. Lifestyle Changes Alone in Sleep Apnea Patients