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Résztvevőt keres itt: IndiaFázis nélkül

Effect of Weight Loss From ESG Plus Lifestyle Changes vs. Lifestyle Changes Alone in Sleep Apnea Patients

A legfontosabb adatok

Ki végzi
Asian Institute of Gastroenterology, India
Hol
Hyderabad (India)A helyszín megnézése
Azonosító
Állapot
Toboroz
Résztvevők
74 fő, tervezett
Kezdés
2025. aug. 19.
Várható befejezés
2029. máj. 19.
A vizsgálat típusa
Beavatkozással járó, 2 csoport
A vizsgált kezelések
  • Endoscopic Sleeve Gastropathy
  • Lifestyle Modification alone
A regiszteradat frissítve
2025. december 19.

Ki vehet részt

MI-összefoglaló

A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.

A vizsgálat olyan felnőtteket keres, akiknek elhízásuk és közepes vagy súlyos obstruktív alvási apnoéjuk van, és az életmódváltással vagy fogyasztó gyógyszerekkel nem fogytak eleget.

Életkor
18 évnél idősebb
Nem
Mindkét nem
A betegség stádiuma
Közepes vagy súlyos obstruktív alvási apnoé (apnoé-hipopnoé index 15 vagy több), elhízással (BMI 40 kg/m² alatt)
Korábbi kezelés
Az életmódváltással és/vagy elhízás elleni gyógyszerekkel nem sikerült elég súlyt leadni. A vizsgálati kezelést követő első 12 hónapban nem tervezett más fogyókúrás kezelés.

A részvétel fő kizáró okai

  • Korábbi vagy tervezett alvási apnoé miatti műtét vagy nagyobb fül-orr-gégészeti műtét
  • Központi vagy kevert alvási apnoé
  • Korábbi bariátriai vagy más gyomor-bélrendszeri műtét, amely miatt az ESG nem végezhető el
  • Jelenlegi vagy tervezett terhesség, illetve szoptatás
  • Nem kezelt pszichiátriai betegség vagy korábbi szerhasználati zavar

A regiszter feltételei, szó szerint

Mind a 24 feltétel megnézéseKevesebb

Ki vehet részt

  • 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

Ki nem vehet részt

  • Any previous or planned surgery for sleep apnea or major ear, nose, or throat surgery
  • Active device treatment of OSA other than continuous positive airway pressure therapy
  • Previous bariatric surgery or any other gastrointestinal surgery where primary ESG will not be feasible
  • 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)
  • 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 inflammatory bowel disease
  • 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
  • Significant craniofacial abnormalities that may affect breathing
  • Diagnosis of central or mixed sleep apnea, or diagnosis of Cheyne-Stokes Respiration Obesity related
  • Requires the use of supplemental oxygen
  • Current or planned pregnancy or breastfeeding while participating in the study

Helyszínek itt: India

  • Asian Institute Of Gastroenterology HospitalsHyderabad, IndiaContact: Dr. Rakesh Kalapala, MD, DNB, FASGE, FJGES, FSGEIRésztvevőt keres

A vizsgálatról

Mit akar kideríteni a vizsgálat

Study Overview:

A teljes eredeti leírásKevesebb

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.

A vizsgálat 2 csoportja

  • Group A: (ESG + Lifestyle Modification)A vizsgált kezelés

    ESG is an endoluminal procedure similar to sleeve gastrectomy targeting the shape of the stomach. The targeted shape is a tubular gastric body with a small pouch in the fundus. The study procedure will be conducted using the Over Stitch endoscopic suturing system according to the Instructions for Use under general anesthesia. Participants will follow a structured program involving a low-calorie diet (typically 1200-1500 kcal/day), regular physical activity (150 minutes of moderate-intensity exercise per week), and behavioural therapy sessions.

    Kezelés: Endoscopic Sleeve Gastropathy és Lifestyle Modification alone

  • Group B: (Lifestyle Modification Alone)A vizsgált kezelés

    Same as described above (Group A), without the ESG procedure.

    Kezelés: Lifestyle Modification alone

Kérdések a vizsgálat csapatának

  1. Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
  2. Megtérítik az utazási költséget?
  3. Megtarthatom a saját orvosomat?
  4. Mi történik, ha ki akarok lépni?

Contact the study team: see the registry record → Contacts and Locations

Oldal nyomtatása az orvosomnak

Adatok és források

Regiszteradat
Szerepel a ClinicalTrials.gov-on.
Hivatalos cím
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
MI-összefoglaló
A vizsgálat saját részvételi feltételeiből. Gépi kiolvasás: 2026. november 12.
A regiszteradat frissítve
2025. december 19.