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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: drrakeshkalapala@aighospitals.com
• Phone: 040 42444 4222

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.