💬In plain words
What the trial is, and whether it could suit you
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 proper
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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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