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

NCT07082608 | Recruiting DMC

• 1 other identifier: ESGVSLMOS
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

OSA - Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• Change in Sleep Apnea Severity (AHI= Apnea Hypopnea Index) After 12 Months of Treatment: ESG Plus Lifestyle vs. Lifestyle Alone

  We will measure the change in Apnea-Hypopnea Index (AHI) score from baseline to 12 months after treatment, comparing the ESG + lifestyle group to the lifestyle-only group.

  12 Months

Secondary Outcomes (6)

• Reduction in OSA Severity with Weight Loss

  12 months

• Weight Loss (TBWL%)

  Up to 24 Months

• Sleep Quality Assessment

  12 Months

• Responder Rate to Weight Loss

  12 and 24 Months

• Change in OSA Severity at 24 Months in ESG Group

  24 Months

Study Arms (2)

Group A: (ESG + Lifestyle Modification)

EXPERIMENTAL

ESG is an endoluminal procedure similar to sleeve gastrectomy targeting the shape of the stomach. The targeted shape is a tubular gastric body with a small pouch in the fundus. The study procedure will be conducted using the Over Stitch endoscopic suturing system according to the Instructions for Use under general anesthesia. 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.

Device: Endoscopic Sleeve Gastropathy; Other: Lifestyle Modification alone

Group B: (Lifestyle Modification Alone)

EXPERIMENTAL

Same as described above (Group A), without the ESG procedure.

Other: Lifestyle Modification alone

Interventions

Endoscopic Sleeve Gastropathy DEVICE

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

Group A: (ESG + Lifestyle Modification)

Lifestyle Modification alone OTHER

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.

Group A: (ESG + Lifestyle Modification); Group B: (Lifestyle Modification Alone)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18years.
• Obesity defined by ethnic specific BMI cut-offs through \< 40 kg/m².
• Diagnosed with moderate to severe OSA (Apnea-Hypopnea Index \[AHI\] ≥15).
• Stable weight (\< 5 kg change) within 3 months prior to screening
• Failure or inadequate weight loss with conservative methods:
• lifestyle modification. and/or
• anti-obesity medications
• No planned additional weight loss treatments (i.e. OTC supplements, pharmacotherapy or bariatric surgery) during the first 12-months following study treatment
• Willingness to comply with the study protocol, including in office follow-up visits and lifestyle modifications.
• Able to sign, understand, and sign a written Informed Consent Form to participate in the study.

You may not qualify if:

• Any previous or planned surgery for sleep apnea or major ear, nose, or throat surgery
• Significant craniofacial abnormalities that may affect breathing
• Diagnosis of central or mixed sleep apnea, or diagnosis of Cheyne-Stokes Respiration Obesity related
• History of disorder, other than OSA, associated with insomnia or excessive daytime sleepiness
• Obesity induced by other endocrinologic disorders, or monogenetic or syndromic forms of obesity
• Active device treatment of OSA other than continuous positive airway pressure therapy
• Requires the use of supplemental oxygen
• Previous bariatric surgery or any other gastrointestinal surgery where primary ESG will not be feasible.
• Active inflammatory bowel disease.
• Current or planned pregnancy or breastfeeding while participating in the study.
• Severe cardiopulmonary conditions contraindicating endoscopy.
• Uncontrolled psychiatric disorders.
• Eating disorder that will impact the ability of the subject to follow the lifestyle modification program
• History of substance abuse.
• Use of any over-the-counter or prescription medications that could affect the evaluation of excessive sleepiness

Sponsors & Collaborators

• Asian Institute of Gastroenterology, India: lead

Study Sites (1)

Asian Institute Of Gastroenterology Hospitals

Hyderabad, Telangana, 500032, India

RECRUITING

Related Publications (8)

• Alexandre F, Lapergola A, Vannucci M, Pizzicannella M, D'Urso A, Saviano A, Mutter D, Vix M, Perretta S. Endoscopic management of obesity: Impact of endoscopic sleeve gastroplasty on weight loss and co-morbidities at six months and one year. J Visc Surg. 2023 Apr;160(2S):S38-S46. doi: 10.1016/j.jviscsurg.2022.12.003. Epub 2023 Jan 30.

  PMID: 36725451 BACKGROUND

• Hedjoudje A, Abu Dayyeh BK, Cheskin LJ, Adam A, Neto MG, Badurdeen D, Morales JG, Sartoretto A, Nava GL, Vargas E, Sui Z, Fayad L, Farha J, Khashab MA, Kalloo AN, Alqahtani AR, Thompson CC, Kumbhari V. Efficacy and Safety of Endoscopic Sleeve Gastroplasty: A Systematic Review and Meta-Analysis. Clin Gastroenterol Hepatol. 2020 May;18(5):1043-1053.e4. doi: 10.1016/j.cgh.2019.08.022. Epub 2019 Aug 20.

  PMID: 31442601 BACKGROUND

• Lopez-Nava G, Sharaiha RZ, Vargas EJ, Bazerbachi F, Manoel GN, Bautista-Castano I, Acosta A, Topazian MD, Mundi MS, Kumta N, Kahaleh M, Herr AM, Shukla A, Aronne L, Gostout CJ, Abu Dayyeh BK. Endoscopic Sleeve Gastroplasty for Obesity: a Multicenter Study of 248 Patients with 24 Months Follow-Up. Obes Surg. 2017 Oct;27(10):2649-2655. doi: 10.1007/s11695-017-2693-7.

  PMID: 28451929 BACKGROUND

• Sharaiha RZ, Kumta NA, Saumoy M, Desai AP, Sarkisian AM, Benevenuto A, Tyberg A, Kumar R, Igel L, Verna EC, Schwartz R, Frissora C, Shukla A, Aronne LJ, Kahaleh M. Endoscopic Sleeve Gastroplasty Significantly Reduces Body Mass Index and Metabolic Complications in Obese Patients. Clin Gastroenterol Hepatol. 2017 Apr;15(4):504-510. doi: 10.1016/j.cgh.2016.12.012. Epub 2016 Dec 23.

  PMID: 28017845 BACKGROUND

• Zhang Y, Wang W, Yang C, Shen J, Shi M, Wang B. Improvement in Nocturnal Hypoxemia in Obese Patients with Obstructive Sleep Apnea after Bariatric Surgery: a Meta-Analysis. Obes Surg. 2019 Feb;29(2):601-608. doi: 10.1007/s11695-018-3573-5.

  PMID: 30411226 BACKGROUND

• Dombrowski SU, Knittle K, Avenell A, Araujo-Soares V, Sniehotta FF. Long term maintenance of weight loss with non-surgical interventions in obese adults: systematic review and meta-analyses of randomised controlled trials. BMJ. 2014 May 14;348:g2646. doi: 10.1136/bmj.g2646.

  PMID: 25134100 BACKGROUND

• Malhotra A, Heilmann CR, Banerjee KK, Dunn JP, Bunck MC, Bednarik J. Weight reduction and the impact on apnea-hypopnea index: A systematic meta-analysis. Sleep Med. 2024 Sep;121:26-31. doi: 10.1016/j.sleep.2024.06.014. Epub 2024 Jun 15.

  PMID: 38908268 BACKGROUND

• Hudgel DW, Patel SR, Ahasic AM, Bartlett SJ, Bessesen DH, Coaker MA, Fiander PM, Grunstein RR, Gurubhagavatula I, Kapur VK, Lettieri CJ, Naughton MT, Owens RL, Pepin JL, Tuomilehto H, Wilson KC; American Thoracic Society Assembly on Sleep and Respiratory Neurobiology. The Role of Weight Management in the Treatment of Adult Obstructive Sleep Apnea. An Official American Thoracic Society Clinical Practice Guideline. Am J Respir Crit Care Med. 2018 Sep 15;198(6):e70-e87. doi: 10.1164/rccm.201807-1326ST.

  PMID: 30215551 BACKGROUND

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Rakesh Kalapala, MD, DNB

  Asian Institute of Gastroeterology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rakesh Kalapala, MD, DNB

CONTACT

040 42444 4222; drrakeshkalapala@aighospitals.com

Nitin Jagtap, MD,DNB

CONTACT

040 42444 4222; docnits13@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Endoscopy (Center for Obesity and Metabolic Therapy)

Study Record Dates

• First Submitted: July 7, 2025
• First Posted: July 24, 2025
• Study Start: August 19, 2025
• Primary Completion (Estimated): May 19, 2029
• Study Completion (Estimated): May 19, 2029
• Last Updated: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)