Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07082608

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

Led by Asian Institute of Gastroenterology, India · Updated on 2025-12-19

74

Participants Needed

1

Research Sites

195 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age over 18 years
  • Obesity defined by ethnic-specific BMI cut-offs below 40 kg/m²
  • Diagnosed with moderate to severe OSA (Apnea-Hypopnea Index ≥15)
  • Stable weight (less than 5 kg change) in the 3 months before screening
  • History of insufficient weight loss from lifestyle changes and/or anti-obesity medications
  • No planned additional weight loss treatments during the first 12 months after study treatment
  • Willingness to follow study protocol including follow-up visits and lifestyle modifications
  • Able to understand and sign informed consent
Not Eligible

You will not qualify if you...

  • Previous or planned surgery for sleep apnea or major ear, nose, or throat surgery
  • Significant craniofacial abnormalities affecting breathing
  • Diagnosis of central or mixed sleep apnea, or Cheyne-Stokes Respiration
  • Disorders other than OSA causing insomnia or excessive daytime sleepiness
  • Obesity due to other endocrine disorders or genetic/syndromic causes
  • Active device treatment for OSA besides continuous positive airway pressure therapy
  • Need for supplemental oxygen
  • Previous bariatric or gastrointestinal surgery that prevents ESG
  • Active inflammatory bowel disease
  • Current or planned pregnancy or breastfeeding
  • Severe heart or lung conditions that contraindicate endoscopy
  • Uncontrolled psychiatric disorders
  • Eating disorders affecting ability to follow lifestyle program
  • History of substance abuse
  • Use of medications affecting evaluation of sleepiness
  • Recent or planned changes in diabetes medications that affect weight loss

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Asian Institute Of Gastroenterology Hospitals

Hyderabad, Telangana, India, 500032

Actively Recruiting

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Research Team

R

Rakesh Kalapala, MD, DNB

CONTACT

N

Nitin Jagtap, MD,DNB

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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