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Tests a stomach-shrinking procedure plus lifestyle changes for sleep apnea in obesity

Compares a stomach-reducing procedure with lifestyle changes alone in adults with obesity and sleep apnea.

Key facts

Who runs it
Asian Institute of Gastroenterology, India
Where
Hyderabad, IndiaSee the site
Trial code
Registry title
Effect of Weight Loss From ESG Plus Lifestyle Changes vs. Lifestyle Changes Alone in Sleep Apnea Patients
Status
Recruiting
People taking part
74 people, planned
Started
19 Aug 2025
Expected to end
19 May 2029
Type of study
Interventional, 2 groups
Treatments tested
  • Endoscopic Sleeve Gastropathy
  • Lifestyle Modification alone
Record updated
19 December 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with obesity and moderate to severe obstructive sleep apnea who have not lost enough weight with lifestyle changes or weight-loss medicines.

Age
Over 18 years
Sex
All sexes
Disease stage
Moderate to severe obstructive sleep apnea (Apnea-Hypopnea Index of 15 or more) with obesity (BMI under 40 kg/m²)
Earlier treatment
Weight loss with lifestyle changes and/or anti-obesity medicines did not work or was not enough. No other weight-loss treatment planned in the first 12 months after study treatment.

Main reasons for not taking part

  • Past or planned surgery for sleep apnea or major ear, nose or throat surgery
  • Central or mixed sleep apnea
  • Past bariatric or other stomach and bowel surgery that would make ESG not possible
  • Current or planned pregnancy or breastfeeding
  • Uncontrolled psychiatric disorders or substance abuse history

The registry criteria, word for word

Show all 24 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Any previous or planned surgery for sleep apnea or major ear, nose, or throat surgery
  • Active device treatment of OSA other than continuous positive airway pressure therapy
  • Previous bariatric surgery or any other gastrointestinal surgery where primary ESG will not be feasible
  • Use of any over-the-counter or prescription medications that could affect the evaluation of excessive sleepiness
  • 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)
  • 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 inflammatory bowel disease
  • 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
  • Significant craniofacial abnormalities that may affect breathing
  • Diagnosis of central or mixed sleep apnea, or diagnosis of Cheyne-Stokes Respiration Obesity related
  • Requires the use of supplemental oxygen
  • Current or planned pregnancy or breastfeeding while participating in the study

Where in India

  • Asian Institute Of Gastroenterology HospitalsHyderabad, IndiaContact: Dr. Rakesh Kalapala, MD, DNB, FASGE, FJGES, FSGEITaking people

About the trial

What the trial wants to find out

Study Overview:

Read full original descriptionShow less

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.

The 2 groups in the trial

  • Group A: (ESG + Lifestyle Modification)Treatment being tested

    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.

    Treatment: Endoscopic Sleeve Gastropathy and Lifestyle Modification alone

  • Group B: (Lifestyle Modification Alone)Treatment being tested

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

    Treatment: Lifestyle Modification alone

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
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
Plain-language title
Tests a stomach-shrinking procedure plus lifestyle changes for sleep apnea in obesityGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
19 December 2025