An interventional study of Endoscopic Sleeve Gastropathy and Lifestyle Modification alone in OSA - Obstructive Sleep Apnea, sponsored by Asian Institute of Gastroenterology, India. Recruiting at 1 site in India. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-19.
Sponsored by Asian Institute of Gastroenterology, India · Not applicable, Interventional, and Treatment
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.
Obesity increases the risk of Obstructive Sleep Apnea (OSA), a condition where breathing stops during sleep. This study aims to find out whether Endoscopic Sleeve Gastroplasty (ESG) with lifestyle changes (like diet and exercise) improves OSA symptoms better than lifestyle changes alone. ESG is a non-surgical procedure that reduces stomach size to help with weight loss. Early studies show ESG can lead to weight loss and may reduce OSA symptoms, but more research is needed. This study will compare both treatment approaches to see which is more effective in improving sleep and overall health in people with obesity and OSA.
Primary Endpoints:
Change in OSA severity (measured by apnea-hypopnea index, AHI) from baseline at 12 months after study procedure by group.
Secondary Endpoints:
Study procedure and / or device related SAEs for the ESG group only Responders to weight loss (≥ 10% Total Body Weight Loss, TBWL) with reduction in OSA severity (AHI reduction ≥ 50%) at 12 months after study procedure by group Weight loss (TBWL%) at each study visit by group Improvement in sleep quality (assessed using validated sleep questionnaires) from baseline at 12 months after study procedure by group Epworth Sleepiness Scale (ESS) Pittsburgh Sleep Quality Index (PSQI) Change in OSA severity from baseline at 24 months after study procedure for the ESG group Responders to weight loss (≥ 10% Total Body Weight Loss, TBWL) with reduction in OSA severity (AHI reduction ≥ 50%) at 24 months after study procedure for the ESG group
Adverse event frequency related to the study procedure Responders to weight loss at each study visit by randomization group Change in OSA severity at each study visit by group Improvement in sleep quality from baseline at each study visit by group Changes in metabolic parameters: HbA1c, fasting glucose, lipid profile, and liver profile.
Changes in blood pressure and inflammatory markers (e.g., hs-CRP). Improvement in quality of life (assessed using validated questionnaires) from baseline at each study visit by group SF-36 IWQOL LITE-CT
2,198 studies on the registry are indexed under Sleep Apnea, Obstructive; 470 are open to participants now.
This study's planned enrollment of 74 is above the median of 53 across 1,448 interventional studies indexed under Sleep Apnea, Obstructive.
Browse Sleep Apnea, Obstructive studies →Asian Institute of Gastroenterology, India is the lead sponsor of 132 studies on the registry; 59 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Failure or inadequate weight loss with conservative methods:
Exclusion Criteria:
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
Same as described above (Group A), without the ESG procedure.
Other: Lifestyle Modification alone
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
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.
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.
Time frame: 12 Months
Reduction in OSA Severity with Weight Loss
Percentage of participants who achieve a ≥50% reduction in AHI from baseline at 12 months post-procedure.
Time frame: 12 months
Weight Loss (TBWL%)
Total Body Weight Loss percentage (TBWL%) at each study visit, compared between groups.
Time frame: Up to 24 Months
Sleep Quality Assessment
Improvement in sleep quality from baseline using validated questionnaires: * Epworth Sleepiness Scale (ESS) * Pittsburgh Sleep Quality Index (PSQI)
Time frame: 12 Months
Responder Rate to Weight Loss
Proportion of participants achieving ≥10% TBWL at 12 and 24 months post-procedure.
Time frame: 12 and 24 Months
Change in OSA Severity at 24 Months in ESG Group
Change in AHI from baseline to 24 months after ESG procedure.
Time frame: 24 Months
Device- or Procedure-Related SAEs
Number of Serious Adverse Events (SAEs) related to the procedure or device in each group.
Time frame: 24 Months
Plan to share: No
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Asian Institute of Gastroenterology, India