OSA - Obstructive Sleep ApneaOSANCT07082608
Effect of Weight Loss From ESG Plus Lifestyle Changes vs. Lifestyle Changes Alone in Sleep Apnea Patients
A study testing Endoscopic Sleeve Gastropathy and Lifestyle Modification alone in people with OSA - Obstructive Sleep Apnea, run by Asian Institute of Gastroenterology, India at 1 site in India.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- OSA - Obstructive Sleep Apnea
- What is being tested?
- Endoscopic Sleeve Gastropathy and Lifestyle Modification alone
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteIndia
- Study dates
- 19 Aug 2025to 19 May 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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.
Who cannot join
- 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
Show all 16Show fewer
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site, 1 recruiting
- Recruiting
Asian Institute Of Gastroenterology Hospitals
Hyderabad, Telangana, 500032
Dr. Rakesh Kalapala, MD, DNB, FASGE, FJGES, FSGEI, 9989211034, drrakesh.kalapala@aighospitals.com
About this study
Official title: 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
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.
Read more
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.
Read the detailed description
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.
- 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
- 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.
Changes in blood pressure and inflammatory markers (e.g., hs-CRP). Improvement in quality of life (assessed using validated questionnaires) from baseline at each study visit by group SF-36 IWQOL LITE-CT
- Conditions
- OSA - Obstructive Sleep Apnea
- Being tested
- Endoscopic Sleeve Gastropathy, Lifestyle Modification alone
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic Sleeve GastropathyDevice
Weight loss through diet, exercise, and behavioural changes positively impacts sleep quality. Reduction in body weight can alleviate OSA symptoms and improve overall sleep architecture1,2,3 Surgical weight loss procedures play a crucial role in managing obesity-related health issues, including OSA.4 Endobariatric procedures, including Endoscopic Sleeve Gastroplasty (ESG), have gained attention as a weight loss solution with the potential for improving obesity-related health issues.
ESG involves suturing the stomach to reduce its size, limiting food intake. Unlike traditional bariatric surgeries, ESG doesn't require incisions. ESG has shown promise in achieving clinically significant weight loss, up to 20% of TBWL. By reducing stomach capacity, it promotes satiety and calorie restriction. ESG is generally safe, with fewer complications compared to more invasive procedures
Lifestyle Modification aloneOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A: (ESG + Lifestyle Modification) | Experimental | 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. Receives: Device: Endoscopic Sleeve Gastropathy; Other: Lifestyle Modification alone |
| Group B: (Lifestyle Modification Alone) | Experimental | Same as described above (Group A), without the ESG procedure. Receives: Other: Lifestyle Modification alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Sleep Apnea Severity (AHI= Apnea Hypopnea Index) After 12 Months of Treatment: ESG Plus Lifestyle vs. Lifestyle Alone
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.
Measured: 12 Months
Secondary outcomes (6)
Reduction in OSA Severity with Weight Loss
Percentage of participants who achieve a ≥50% reduction in AHI from baseline at 12 months post-procedure.
Measured: 12 months
Weight Loss (TBWL%)
Total Body Weight Loss percentage (TBWL%) at each study visit, compared between groups.
Measured: Up to 24 Months
Sleep Quality Assessment
Improvement in sleep quality from baseline using validated questionnaires:
- Epworth Sleepiness Scale (ESS)
- Pittsburgh Sleep Quality Index (PSQI)
Measured: 12 Months
Responder Rate to Weight Loss
Proportion of participants achieving ≥10% TBWL at 12 and 24 months post-procedure.
Measured: 12 and 24 Months
Change in OSA Severity at 24 Months in ESG Group
Change in AHI from baseline to 24 months after ESG procedure.
Measured: 24 Months
Device- or Procedure-Related SAEs
Number of Serious Adverse Events (SAEs) related to the procedure or device in each group.
Measured: 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study start19 Aug 2025
- Primary completion19 May 2029 (estimated)
- Study completion19 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for OSA - Obstructive Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asian Institute of Gastroenterology, India
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rakesh Kalapala, Asian Institute of Gastroenterology, India
- Investigators
- Rakesh Kalapala, MD, DNB, Principal investigator, Asian Institute of Gastroeterology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07082608
- Sponsor's protocol ID
- ESGVSLMOS
- Acronym
- OSA
- Status last verified
- Dec 2025
- First submitted
- 7 Jul 2025
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alexandre F, Lapergola A, Vannucci M, Pizzicannella M, D'Urso A, Saviano A, Mutter D, Vix M, Perretta S. Endoscopic management of obesity: Impact of endoscopic sleeve gastroplasty on weight loss and co-morbidities at six months and one year. J Visc Surg. 2023 Apr;160(2S):S38-S46. doi: 10.1016/j.jviscsurg.2022.12.003. Epub 2023 Jan 30.
PubMed 36725451Hedjoudje A, Abu Dayyeh BK, Cheskin LJ, Adam A, Neto MG, Badurdeen D, Morales JG, Sartoretto A, Nava GL, Vargas E, Sui Z, Fayad L, Farha J, Khashab MA, Kalloo AN, Alqahtani AR, Thompson CC, Kumbhari V. Efficacy and Safety of Endoscopic Sleeve Gastroplasty: A Systematic Review and Meta-Analysis. Clin Gastroenterol Hepatol. 2020 May;18(5):1043-1053.e4. doi: 10.1016/j.cgh.2019.08.022. Epub 2019 Aug 20.
PubMed 31442601Lopez-Nava G, Sharaiha RZ, Vargas EJ, Bazerbachi F, Manoel GN, Bautista-Castano I, Acosta A, Topazian MD, Mundi MS, Kumta N, Kahaleh M, Herr AM, Shukla A, Aronne L, Gostout CJ, Abu Dayyeh BK. Endoscopic Sleeve Gastroplasty for Obesity: a Multicenter Study of 248 Patients with 24 Months Follow-Up. Obes Surg. 2017 Oct;27(10):2649-2655. doi: 10.1007/s11695-017-2693-7.
PubMed 28451929Sharaiha RZ, Kumta NA, Saumoy M, Desai AP, Sarkisian AM, Benevenuto A, Tyberg A, Kumar R, Igel L, Verna EC, Schwartz R, Frissora C, Shukla A, Aronne LJ, Kahaleh M. Endoscopic Sleeve Gastroplasty Significantly Reduces Body Mass Index and Metabolic Complications in Obese Patients. Clin Gastroenterol Hepatol. 2017 Apr;15(4):504-510. doi: 10.1016/j.cgh.2016.12.012. Epub 2016 Dec 23.
PubMed 28017845Zhang Y, Wang W, Yang C, Shen J, Shi M, Wang B. Improvement in Nocturnal Hypoxemia in Obese Patients with Obstructive Sleep Apnea after Bariatric Surgery: a Meta-Analysis. Obes Surg. 2019 Feb;29(2):601-608. doi: 10.1007/s11695-018-3573-5.
PubMed 30411226Dombrowski SU, Knittle K, Avenell A, Araujo-Soares V, Sniehotta FF. Long term maintenance of weight loss with non-surgical interventions in obese adults: systematic review and meta-analyses of randomised controlled trials. BMJ. 2014 May 14;348:g2646. doi: 10.1136/bmj.g2646.
PubMed 25134100Malhotra A, Heilmann CR, Banerjee KK, Dunn JP, Bunck MC, Bednarik J. Weight reduction and the impact on apnea-hypopnea index: A systematic meta-analysis. Sleep Med. 2024 Sep;121:26-31. doi: 10.1016/j.sleep.2024.06.014. Epub 2024 Jun 15.
PubMed 38908268Hudgel DW, Patel SR, Ahasic AM, Bartlett SJ, Bessesen DH, Coaker MA, Fiander PM, Grunstein RR, Gurubhagavatula I, Kapur VK, Lettieri CJ, Naughton MT, Owens RL, Pepin JL, Tuomilehto H, Wilson KC; American Thoracic Society Assembly on Sleep and Respiratory Neurobiology. The Role of Weight Management in the Treatment of Adult Obstructive Sleep Apnea. An Official American Thoracic Society Clinical Practice Guideline. Am J Respir Crit Care Med. 2018 Sep 15;198(6):e70-e87. doi: 10.1164/rccm.201807-1326ST.
PubMed 30215551
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07082608
- Acronym / sponsor ID
- OSA / ESGVSLMOS
- Conditions
- OSA - Obstructive Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Asian Institute of Gastroenterology, IndiaUniversity, hospital or other
- Study start
- 19 Aug 2025 (actual)
- Primary completion
- 19 May 2029 (estimated)
- Study completion
- 19 May 2029 (estimated)
- First posted
- 24 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
- 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
- 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.
Changes in blood pressure and inflammatory markers (e.g., hs-CRP). Improvement in quality of life (assessed using validated questionnaires) from baseline at each study visit by group SF-36 IWQOL LITE-CT
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: (ESG + Lifestyle Modification) | Experimental | Device: Endoscopic Sleeve Gastropathy, Other: Lifestyle Modification aloneESG 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. |
| Group B: (Lifestyle Modification Alone) | Experimental | Other: Lifestyle Modification aloneSame as described above (Group A), without the ESG procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopic Sleeve GastropathyWeight loss through diet, exercise, and behavioural changes positively impacts sleep quality. Reduction in body weight can alleviate OSA symptoms and improve overall sleep architecture1,2,3 Surgical weight loss procedures play a crucial role in managing obesity-related health issues, including OSA.4 Endobariatric procedures, including Endoscopic Sleeve Gastroplasty (ESG), have gained attention as a weight loss solution with the potential for improving obesity-related health issues. ESG involves suturing the stomach to reduce its size, limiting food intake. Unlike traditional bariatric surgeries, ESG doesn't require incisions. ESG has shown promise in achieving clinically significant weight loss, up to 20% of TBWL. By reducing stomach capacity, it promotes satiety and calorie restriction. ESG is generally safe, with fewer complications compared to more invasive procedures | Device | Group A: (ESG + Lifestyle Modification) |
| Lifestyle Modification aloneParticipants 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. | Other | Group A: (ESG + Lifestyle Modification), Group B: (Lifestyle Modification Alone) |
Primary outcome
Change in Sleep Apnea Severity (AHI= Apnea Hypopnea Index) After 12 Months of Treatment: ESG Plus Lifestyle vs. Lifestyle Alone
Time frame: 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.
6 secondary outcomes
Reduction in OSA Severity with Weight Loss
Time frame: 12 months
Weight Loss (TBWL%)
Time frame: Up to 24 Months
Sleep Quality Assessment
Time frame: 12 Months
Responder Rate to Weight Loss
Time frame: 12 and 24 Months
Change in OSA Severity at 24 Months in ESG Group
Time frame: 24 Months
Device- or Procedure-Related SAEs
Time frame: 24 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Background: PubMed 36725451Alexandre F, Lapergola A, Vannucci M, Pizzicannella M, D'Urso A, Saviano A, Mutter D, Vix M, Perretta S. Endoscopic management of obesity: Impact of endoscopic sleeve gastroplasty on weight loss and co-morbidities at six months and one year. J Visc Surg. 2023 Apr;160(2S):S38-S46. doi: 10.1016/j.jviscsurg.2022.12.003. Epub 2023 Jan 30.
- Background: PubMed 31442601Hedjoudje A, Abu Dayyeh BK, Cheskin LJ, Adam A, Neto MG, Badurdeen D, Morales JG, Sartoretto A, Nava GL, Vargas E, Sui Z, Fayad L, Farha J, Khashab MA, Kalloo AN, Alqahtani AR, Thompson CC, Kumbhari V. Efficacy and Safety of Endoscopic Sleeve Gastroplasty: A Systematic Review and Meta-Analysis. Clin Gastroenterol Hepatol. 2020 May;18(5):1043-1053.e4. doi: 10.1016/j.cgh.2019.08.022. Epub 2019 Aug 20.
- Background: PubMed 28451929Lopez-Nava G, Sharaiha RZ, Vargas EJ, Bazerbachi F, Manoel GN, Bautista-Castano I, Acosta A, Topazian MD, Mundi MS, Kumta N, Kahaleh M, Herr AM, Shukla A, Aronne L, Gostout CJ, Abu Dayyeh BK. Endoscopic Sleeve Gastroplasty for Obesity: a Multicenter Study of 248 Patients with 24 Months Follow-Up. Obes Surg. 2017 Oct;27(10):2649-2655. doi: 10.1007/s11695-017-2693-7.
- Background: PubMed 28017845Sharaiha RZ, Kumta NA, Saumoy M, Desai AP, Sarkisian AM, Benevenuto A, Tyberg A, Kumar R, Igel L, Verna EC, Schwartz R, Frissora C, Shukla A, Aronne LJ, Kahaleh M. Endoscopic Sleeve Gastroplasty Significantly Reduces Body Mass Index and Metabolic Complications in Obese Patients. Clin Gastroenterol Hepatol. 2017 Apr;15(4):504-510. doi: 10.1016/j.cgh.2016.12.012. Epub 2016 Dec 23.
- Background: PubMed 30411226Zhang Y, Wang W, Yang C, Shen J, Shi M, Wang B. Improvement in Nocturnal Hypoxemia in Obese Patients with Obstructive Sleep Apnea after Bariatric Surgery: a Meta-Analysis. Obes Surg. 2019 Feb;29(2):601-608. doi: 10.1007/s11695-018-3573-5.
- Background: PubMed 25134100Dombrowski SU, Knittle K, Avenell A, Araujo-Soares V, Sniehotta FF. Long term maintenance of weight loss with non-surgical interventions in obese adults: systematic review and meta-analyses of randomised controlled trials. BMJ. 2014 May 14;348:g2646. doi: 10.1136/bmj.g2646.
- Background: PubMed 38908268Malhotra A, Heilmann CR, Banerjee KK, Dunn JP, Bunck MC, Bednarik J. Weight reduction and the impact on apnea-hypopnea index: A systematic meta-analysis. Sleep Med. 2024 Sep;121:26-31. doi: 10.1016/j.sleep.2024.06.014. Epub 2024 Jun 15.
- Background: PubMed 30215551Hudgel DW, Patel SR, Ahasic AM, Bartlett SJ, Bessesen DH, Coaker MA, Fiander PM, Grunstein RR, Gurubhagavatula I, Kapur VK, Lettieri CJ, Naughton MT, Owens RL, Pepin JL, Tuomilehto H, Wilson KC; American Thoracic Society Assembly on Sleep and Respiratory Neurobiology. The Role of Weight Management in the Treatment of Adult Obstructive Sleep Apnea. An Official American Thoracic Society Clinical Practice Guideline. Am J Respir Crit Care Med. 2018 Sep 15;198(6):e70-e87. doi: 10.1164/rccm.201807-1326ST.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rakesh Kalapala, MD, DNB principal investigator
Asian Institute of Gastroeterology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic Sleeve Gastropathy and Lifestyle Modification alone in people with OSA - Obstructive Sleep Apnea, run by Asian Institute of Gastroenterology, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rakesh Kalapala, MD, DNB (040 42444 4222 ext. 2000, drrakeshkalapala@aighospitals.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Sleep Apnea Severity (AHI= Apnea Hypopnea Index) After 12 Months of Treatment: ESG Plus Lifestyle vs. Lifestyle Alone (time frame: 12 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07082608, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.