Sleep Disorders Trial, Recruiting NCT07082608 Sponsor: Asian Institute of Gastroenterology, India Condition: Sleep Disorders
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Sleep Disorders Trial, Recruiting

NCT07082608
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who are over 18 years old
  • People whose BMI falls within the obesity range for their ethnic background, but below 40 kg/m²
  • People who have been diagnosed with moderate to severe obstructive sleep apnea (a sleep breathing condition with an AHI score of 15 or higher)
  • People whose weight has been stable (changed by less than 5 kg) in the 3 months before the screening visit
  • People who have tried lifestyle changes and/or weight loss medications but have not achieved adequate weight loss
  • People who are not planning to use any other weight loss treatments — such as over-the-counter supplements, weight loss medications, or weight loss surgery — in the first 12 months after receiving the study treatment
  • People who are willing to follow the study schedule, including attending in-person follow-up visits and making lifestyle changes
  • People who are able to read, understand, and sign a consent form agreeing to take part in the study

Who may not be able to join:

  • People who have previously had, or are planning to have, surgery for sleep apnea or major ear, nose, or throat surgery
  • People with significant structural abnormalities of the face or skull that may affect breathing
  • People diagnosed with central or mixed sleep apnea, or a breathing pattern during sleep called Cheyne-Stokes Respiration related to obesity
  • People with a condition other than obstructive sleep apnea that causes insomnia or excessive daytime sleepiness
  • People whose obesity is caused by a hormonal disorder or a genetic or syndromic condition
  • People currently using a device to treat sleep apnea, other than a CPAP (continuous positive airway pressure) machine
  • People who require supplemental oxygen
  • People who have previously had weight loss surgery or any stomach or bowel surgery that would make a specific endoscopic procedure (confirm with trial site) not possible
  • People with active inflammatory bowel disease
  • People who are currently pregnant, planning to become pregnant, or breastfeeding during the study
  • People with serious heart or lung conditions that make endoscopy (a camera procedure) unsafe
  • People with uncontrolled psychiatric (mental health) conditions
  • People with an eating disorder that would make it difficult to follow a lifestyle modification program
  • People with a history of substance abuse
  • People currently taking any over-the-counter or prescription medications that could affect measurements of daytime sleepiness
  • People with type 2 diabetes who have changed, or are planning to change, their blood sugar medication within 3 months of the screening visit, particularly medications that may also affect weight (such as GLP-1 medications)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 23 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Rakesh Kalapala, MD, DNB, Asian Institute of Gastroeterology

Phone: 040 42444 4222

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Asian Institute of Gastroenterology, India
Registry
ClinicalTrials.gov
Start date
19 August 2025
Est. completion
19 May 2029

Where this trial is recruiting

🇮🇳 India

Primary endpoints

Change in Sleep Apnea Severity (AHI= Apnea Hypopnea Index) After 12 Months of Treatment: ESG Plus Lifestyle vs. Lifestyle Alone

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 23 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov