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New treatment option for OSA - Obstructive Sleep Apnea
Official title Effect of Weight Loss From ESG Plus Lifestyle Changes vs. Lifestyle Changes Alone in Sleep Apnea Patients
ClinicalTrials.gov ID: NCT07082608
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age \> 18years.
- Obesity defined by ethnic specific BMI cut-offs through \< 40 kg/m².
- Diagnosed with moderate to severe OSA (Apnea-Hypopnea Index [AHI] ≥15).
- Stable weight (\< 5 kg change) within 3 months prior to screening
- Failure or inadequate weight loss with conservative methods:
You likely can't join if
- Any previous or planned surgery for sleep apnea or major ear, nose, or throat surgery
- Significant craniofacial abnormalities that may affect breathing
- Diagnosis of central or mixed sleep apnea, or diagnosis of Cheyne-Stokes Respiration Obesity related
- History of disorder, other than OSA, associated with insomnia or excessive daytime sleepiness
- Obesity induced by other endocrinologic disorders, or monogenetic or syndromic forms of obesity
- Active device treatment of OSA other than continuous positive airway pressure therapy
See the full eligibility criteria
- Age \> 18years.
- Obesity defined by ethnic specific BMI cut-offs through \< 40 kg/m².
- Diagnosed with moderate to severe OSA (Apnea-Hypopnea Index [AHI] ≥15).
- Stable weight (\< 5 kg change) within 3 months prior to screening
- Failure or inadequate weight loss with conservative methods:
- lifestyle modification. and/or
- anti-obesity medications
- No planned additional weight loss treatments (i.e. OTC supplements, pharmacotherapy or bariatric surgery) during the first 12-months following study treatment
- Willingness to comply with the study protocol, including in office follow-up visits and lifestyle modifications.
- Able to sign, understand, and sign a written Informed Consent Form to participate in the study.
- Any previous or planned surgery for sleep apnea or major ear, nose, or throat surgery
- Significant craniofacial abnormalities that may affect breathing
- Diagnosis of central or mixed sleep apnea, or diagnosis of Cheyne-Stokes Respiration Obesity related
- History of disorder, other than OSA, associated with insomnia or excessive daytime sleepiness
- Obesity induced by other endocrinologic disorders, or monogenetic or syndromic forms of obesity
- Active device treatment of OSA other than continuous positive airway pressure therapy
- Requires the use of supplemental oxygen
- Previous bariatric surgery or any other gastrointestinal surgery where primary ESG will not be feasible.
- Active inflammatory bowel disease.
- Current or planned pregnancy or breastfeeding while participating in the study.
- Severe cardiopulmonary conditions contraindicating endoscopy.
- Uncontrolled psychiatric disorders.
- Eating disorder that will impact the ability of the subject to follow the lifestyle modification program
- History of substance abuse.
- Use of any over-the-counter or prescription medications that could affect the evaluation of excessive sleepiness
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Hyderabad, Telangana, India
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hyderabad, Telangana, India. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.