Stomach stitches for better sleep: new study tests weight loss procedure against sleep apnea
NCT ID NCT07082608
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at whether a weight-loss procedure called Endoscopic Sleeve Gastroplasty (ESG), combined with healthy eating and exercise, can improve obstructive sleep apnea (OSA) in people with obesity. About 74 adults with moderate to severe OSA will be randomly assigned to receive ESG plus lifestyle changes or lifestyle changes alone. The main goal is to see if the ESG group has a greater reduction in sleep apnea severity after 12 months.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 74 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2025
- Expected to finish
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May 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
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Contacts and locations
Locations
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Asian Institute Of Gastroenterology Hospitals
RECRUITINGHyderabad, Telangana, 500032, India
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