Endoscopic sleeve gastroplasty plus lifestyle changes versus lifestyle changes alone for people with obesity and obstructive sleep apnea

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

This trial tests whether adding endoscopic sleeve gastroplasty (a non-surgical stomach-reducing procedure) to healthy eating and exercise helps adults with obesity and moderate-to-severe obstructive sleep apnea lose more weight and improve breathing during sleep.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 74 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Asian Institute of Gastroenterology, India (Academic / other)
• Locations: 1 site (Hyderabad, Telangana)
• Trial ID: NCT07082608 on ClinicalTrials.gov

What this trial studies

This interventional trial compares two approaches for adults with obesity and moderate-to-severe obstructive sleep apnea: endoscopic sleeve gastroplasty (ESG) combined with structured lifestyle modification versus lifestyle modification alone. ESG is a non-surgical endoscopic procedure that reduces stomach volume to promote weight loss. Participants will be followed with sleep studies (AHI), weight measurements, and validated sleep questionnaires at baseline and at 12 months, with additional safety and longer-term endpoints assessed up to 24 months. The primary outcome is change in apnea-hypopnea index (AHI) at 12 months; secondary outcomes include percent total body weight loss, responder rates, sleep quality scores, and procedure-related adverse events.

Who should consider this trial

Good fit: Adults over 18 with obesity (below BMI 40 using ethnic cutoffs) and moderate-to-severe OSA (AHI ≥ 15) who have had inadequate weight loss with conservative measures and can attend follow-up visits are ideal candidates.

Not a fit: Patients with central or mixed sleep apnea, significant craniofacial abnormalities, prior or planned sleep apnea surgery, or those planning other weight-loss treatments during the first 12 months are unlikely to benefit from this comparison.

Why it matters

Potential benefit: If successful, adding ESG to lifestyle changes could produce larger weight loss and bigger improvements in sleep apnea severity than lifestyle changes alone.

How similar studies have performed: Early studies of ESG have demonstrated meaningful weight loss and some improvement in sleep apnea symptoms, but randomized comparisons against lifestyle modification alone remain limited.

Eligibility criteria

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)

Where this trial is running

Hyderabad, Telangana

• Asian Institute Of Gastroenterology Hospitals — Hyderabad, Telangana, India (Recruiting)

Study contacts

• Principal investigator: Rakesh Kalapala, MD, DNB — Asian Institute of Gastroeterology
• Study coordinator: Rakesh Kalapala, MD, DNB

Conditions OSA - Obstructive Sleep Apnea