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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 74
- 试验地点
- 2
- 主要终点
- Change in Sleep Apnea Severity (AHI= Apnea Hypopnea Index) After 12 Months of Treatment: ESG Plus Lifestyle vs. Lifestyle Alone
研究概览
简要总结
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 properly during sleep
Losing weight can reduce these problems, ease OSA symptoms, and help improve sleep. Even a moderate amount of weight loss can make a big difference.
How Can People Lose Weight?
Many people try to lose weight through:
Diet changes
Exercise
Behavioural changes like mindful eating
These methods can help, but some people find it hard to lose enough weight or keep it off. That's where medical procedures like ESG can help.
What is ESG (Endoscopic Sleeve Gastroplasty)?
ESG is a non-surgical, minimally invasive weight-loss procedure. It works by reducing the size of your stomach using stitches (done through a tube inserted through your mouth-no cuts or incisions on the body). A smaller stomach means you feel full sooner and eat less.
Benefits of ESG:
Helps you lose weight (up to 20% of total body weight)
Lower risk of complications than traditional surgery
Short recovery time
No hospital stay in most cases
What Does the Research Say So Far?
Some early studies have shown that ESG can help people lose a significant amount of weight and may also improve conditions related to obesity, such as OSA.
One study followed 99 people for a year after ESG. About 30% had OSA at the start. After the procedure, many reported improvement in their OSA symptoms.
Another study compared ESG with a more invasive surgery (laparoscopic sleeve gastrectomy or LSG). While LSG led to more weight loss, both groups showed similar improvements in OSA symptoms.
This shows that ESG may be a good option for improving OSA, but more research is needed to fully understand its benefits.
Why Is This Study Important?
With obesity and OSA becoming more common, it is important to find effective and safe treatments. This study will help us learn:
How much ESG can improve sleep and breathing in people with OSA
Whether combining ESG with lifestyle changes is better than lifestyle changes alone
How ESG impacts other health problems linked to obesity
What We Hope to Learn:
We believe that weight loss from ESG will:
Reduce the severity of OSA
Improve sleep quality
Improve overall health
The results of this study could help guide future treatment options for people with obesity and sleep apnea.
详细描述
Obesity increases the risk of Obstructive Sleep Apnea (OSA), a condition where breathing stops during sleep. This study aims to find out whether Endoscopic Sleeve Gastroplasty (ESG) with lifestyle changes (like diet and exercise) improves OSA symptoms better than lifestyle changes alone. ESG is a non-surgical procedure that reduces stomach size to help with weight loss. Early studies show ESG can lead to weight loss and may reduce OSA symptoms, but more research is needed. This study will compare both treatment approaches to see which is more effective in improving sleep and overall health in people with obesity and OSA.
- Primary Endpoints:
Change in OSA severity (measured by apnea-hypopnea index, AHI) from baseline at 12 months after study procedure by group. 2. Secondary Endpoints:
Study procedure and / or device related SAEs for the ESG group only Responders to weight loss (≥ 10% Total Body Weight Loss, TBWL) with reduction in OSA severity (AHI reduction ≥ 50%) at 12 months after study procedure by group Weight loss (TBWL%) at each study visit by group Improvement in sleep quality (assessed using validated sleep questionnaires) from baseline at 12 months after study procedure by group Epworth Sleepiness Scale (ESS) Pittsburgh Sleep Quality Index (PSQI) Change in OSA severity from baseline at 24 months after study procedure for the ESG group Responders to weight loss (≥ 10% Total Body Weight Loss, TBWL) with reduction in OSA severity (AHI reduction ≥ 50%) at 24 months after study procedure for the ESG group 3. Additional Endpoints:
Adverse event frequency related to the study procedure Responders to weight loss at each study visit by randomization group Change in OSA severity at each study visit by group Improvement in sleep quality from baseline at each study visit by group Changes in metabolic parameters: HbA1c, fasting glucose, lipid profile, and liver profile.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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)
结局指标
主要结局
Change in Sleep Apnea Severity (AHI= Apnea Hypopnea Index) After 12 Months of Treatment: ESG Plus Lifestyle vs. Lifestyle Alone
时间窗: 12 Months
We will measure the change in Apnea-Hypopnea Index (AHI) score from baseline to 12 months after treatment, comparing the ESG + lifestyle group to the lifestyle-only group.
次要结局
- Reduction in OSA Severity with Weight Loss(12 months)
- Weight Loss (TBWL%)(Up to 24 Months)
- Sleep Quality Assessment(12 Months)
- Responder Rate to Weight Loss(12 and 24 Months)
- Change in OSA Severity at 24 Months in ESG Group(24 Months)
- Device- or Procedure-Related SAEs(24 Months)
研究者
Rakesh Kalapala
Director Endoscopy (Center for Obesity and Metabolic Therapy)
Asian Institute of Gastroenterology, India