RECRUITINGINTERVENTIONAL

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

Impact of Weight Loss From Endoscopic Sleeve Gastropathy (ESG) Plus Life Style Modification VS Life Style Modification Alone on Obstructive Sleep Apnea (OSA) Patients With Obesity - Randomized Controlled Trial

About This Trial

Study Overview: Obesity and Obstructive Sleep Apnea (OSA) are strongly linked. This study aims to understand whether a procedure called Endoscopic Sleeve Gastroplasty (ESG), along with lifestyle changes like healthy eating and regular exercise, can help improve symptoms of OSA in people with obesity. What is Obstructive Sleep Apnea (OSA)? OSA is a condition where your breathing repeatedly stops and starts during sleep. This happens when the airway becomes blocked-often due to extra fat around the neck and throat in people with obesity. These breathing interruptions can lead to poor sleep quality, daytime tiredness, mood issues, and long-term health risks like high blood pressure and heart problems. Why Does Weight Matter? Obesity is a major cause of OSA. Being overweight can cause: Narrowing of the airway More inflammation in the body Hormonal changes Difficulty breathing properly during sleep Losing weight can reduce these problems, ease OSA symptoms, and help improve sleep. Even a moderate amount of weight loss can make a big difference. How Can People Lose Weight? Many people try to lose weight through: Diet changes Exercise Behavioural changes like mindful eating These methods can help, but some people find it hard to lose enough weight or keep it off. That's where medical procedures like ESG can help. What is ESG (Endoscopic Sleeve Gastroplasty)? ESG is a non-surgical, minimally invasive weight-loss procedure. It works by reducing the size of your stomach using stitches (done through a tube inserted through your mouth-no cuts or incisions on the body). A smaller stomach means you feel full sooner and eat less. Benefits of ESG: Helps you lose weight (up to 20% of total body weight) Lower risk of complications than traditional surgery Short recovery time No hospital stay in most cases What Does the Research Say So Far? Some early studies have shown that ESG can help people lose a significant amount of weight and may also improve conditions related to obesity, such as OSA. One study followed 99 people for a year after ESG. About 30% had OSA at the start. After the procedure, many reported improvement in their OSA symptoms. Another study compared ESG with a more invasive surgery (laparoscopic sleeve gastrectomy or LSG). While LSG led to more weight loss, both groups showed similar improvements in OSA symptoms. This shows that ESG may be a good option for improving OSA, but more research is needed to fully understand its benefits. Why Is This Study Important? With obesity and OSA becoming more common, it is important to find effective and safe treatments. This study will help us learn: How much ESG can improve sleep and breathing in people with OSA Whether combining ESG with lifestyle changes is better than lifestyle changes alone How ESG impacts other health problems linked to obesity What We Hope to Learn: We believe that weight loss from ESG will: Reduce the severity of OSA Improve sleep quality Improve overall health The results of this study could help guide future treatment options for people with obesity and sleep apnea.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Age \> 18years. 2. Obesity defined by ethnic specific BMI cut-offs through \< 40 kg/m². 3. Diagnosed with moderate to severe OSA (Apnea-Hypopnea Index \[AHI\] ≥15). 4. Stable weight (\< 5 kg change) within 3 months prior to screening 5. Failure or inadequate weight loss with conservative methods: 1. lifestyle modification. and/or 2. anti-obesity medications 6. No planned additional weight loss treatments (i.e. OTC supplements, pharmacotherapy or bariatric surgery) during the first 12-months following study treatment 7. Willingness to comply with the study protocol, including in office follow-up visits and lifestyle modifications. 8. Able to sign, understand, and sign a written willing to sign a consent form Form to participate in the study. Who Should NOT Join This Trial: 1. Any previous or planned surgery for sleep apnea or major ear, nose, or throat surgery 2. Significant craniofacial abnormalities that may affect breathing 3. Diagnosis of central or mixed sleep apnea, or diagnosis of Cheyne-Stokes Respiration Obesity related 4. History of disorder, other than OSA, associated with insomnia or excessive daytime sleepiness 5. Obesity induced by other endocrinologic disorders, or monogenetic or syndromic forms of obesity 6. Active device treatment of OSA other than continuous positive airway pressure therapy 7. Requires the use of supplemental oxygen 8. Previous bariatric surgery or any other gastrointestinal surgery where primary ESG will not be feasible. 9. Active inflammatory bowel disease. 10. Current or planned pregnancy or breastfeeding while participating in the study. 11. Severe cardiopulmonary conditions contraindicating endoscopy. 12. Uncontrolled psychiatric disorders. 13. Eating disorder that will impact the ability of the subject to follow the lifestyle modification program 14. History of substance abuse. 15. Use of any over-the-counter or prescription medications that could affect the evaluation of excessive sleepiness ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: 1. Age \> 18years. 2. Obesity defined by ethnic specific BMI cut-offs through \< 40 kg/m². 3. Diagnosed with moderate to severe OSA (Apnea-Hypopnea Index \[AHI\] ≥15). 4. Stable weight (\< 5 kg change) within 3 months prior to screening 5. Failure or inadequate weight loss with conservative methods: 1. lifestyle modification. and/or 2. anti-obesity medications 6. No planned additional weight loss treatments (i.e. OTC supplements, pharmacotherapy or bariatric surgery) during the first 12-months following study treatment 7. Willingness to comply with the study protocol, including in office follow-up visits and lifestyle modifications. 8. Able to sign, understand, and sign a written Informed Consent Form to participate in the study. Exclusion Criteria: 1. Any previous or planned surgery for sleep apnea or major ear, nose, or throat surgery 2. Significant craniofacial abnormalities that may affect breathing 3. Diagnosis of central or mixed sleep apnea, or diagnosis of Cheyne-Stokes Respiration Obesity related 4. History of disorder, other than OSA, associated with insomnia or excessive daytime sleepiness 5. Obesity induced by other endocrinologic disorders, or monogenetic or syndromic forms of obesity 6. Active device treatment of OSA other than continuous positive airway pressure therapy 7. Requires the use of supplemental oxygen 8. Previous bariatric surgery or any other gastrointestinal surgery where primary ESG will not be feasible. 9. Active inflammatory bowel disease. 10. Current or planned pregnancy or breastfeeding while participating in the study. 11. Severe cardiopulmonary conditions contraindicating endoscopy. 12. Uncontrolled psychiatric disorders. 13. Eating disorder that will impact the ability of the subject to follow the lifestyle modification program 14. History of substance abuse. 15. Use of any over-the-counter or prescription medications that could affect the evaluation of excessive sleepiness 16. Type 2 diabetics that has had a change within 3 months of the screening visit or planned change in medication for blood sugar management that has thee potential to impact weight loss (i.e. GLP-1 medications)

Treatments Being Tested

DEVICE

Endoscopic Sleeve Gastropathy

Weight loss through diet, exercise, and behavioural changes positively impacts sleep quality. Reduction in body weight can alleviate OSA symptoms and improve overall sleep architecture1,2,3 Surgical weight loss procedures play a crucial role in managing obesity-related health issues, including OSA.4 Endobariatric procedures, including Endoscopic Sleeve Gastroplasty (ESG), have gained attention as a weight loss solution with the potential for improving obesity-related health issues. ESG involves suturing the stomach to reduce its size, limiting food intake. Unlike traditional bariatric surgeries, ESG doesn't require incisions. ESG has shown promise in achieving clinically significant weight loss, up to 20% of TBWL. By reducing stomach capacity, it promotes satiety and calorie restriction. ESG is generally safe, with fewer complications compared to more invasive procedures

OTHER

Lifestyle Modification alone

Participants will follow a structured program involving a low-calorie diet (typically 1200-1500 kcal/day), regular physical activity (150 minutes of moderate-intensity exercise per week), and behavioural therapy sessions.

Locations (1)

Asian Institute Of Gastroenterology Hospitals

Hyderabad, Telangana, India