Effect of Endoscopic Gastric Balloon Insertion on Obstructive Sleep Apnea in Patients With Morbid Obesity

To investigate the effect of weight loss by gastric balloon insertion on parameters of obstructive sleep apnea.

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Key information

Conditions

Morbid Obesity Apnea Body Weight Dyssomnias Nervous System Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Morbid Obstructive Sleep Apnea Overnutrition Overweight Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Prince of Wales Hospital

Hong Kong, China

About this study

Most of the patients with obstructive sleep apnea (OSA) are obese. It has been noted that significant weight loss could improve the severity of sleep apnea. Significant weight loss is difficult to achieve especially in morbidly obese patients. Endoscopic gastric balloon insertion is minimally invasive procedure is employed by surgeon for weight reduction for morbidly obese patients. This study would assess the parameters of sleep which could be affected by weight reduction. If results are positive, this procedure might be considered as treatment for obstructive sleep apnea in morbidly obese patients.

Patient population would be selected from patients who would undergo gastric balloon insertion in the surgical department. There would be no sex or age limit. Patient recruited would have BMI > 35. Consent would be signed for sleep studies. Baseline sleep study, lung function, Epworth Sleepiness Scale (ESS) and quality of life would be assessed in patients who have symptoms suggestive of OSA. If a patient is confirmed to have OSA, a continuous positive airway pressure (CPAP) titration would be offered if the patient is willing to try CPAP. Otherwise patients would be discharged home and wait for balloon insertion. The same assessment would be repeated 3 months and 6 months after the surgical procedure. All sleep studies would be done as in-patient.

Leptin and ghrelin are hormones control satiety, which are also related to the degree of obesity. Blood for plasma leptin and ghrelin would be taken before and 6 months after gastric balloon insertion to assess the relationship of weight reduction by reducing appetite and plasma level of the hormones

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

morbidly obese patients with BMI > 30
confirmed obstructive sleep apnea with RDI > 10/hr
able to sign consent

Exclusion criteria

patients undergoing weight reduction surgery
sleep apnea other than obstructive sleep apnea
untreated endocrine disorder
patient refusal

Treatment and study plan

gastric balloon insertion

Procedure

patient would be offered endoscopic gastric balloon insertion

Other names: gastric balloon

Primary outcomes

effect of gastric balloon on sleep apnea

Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Important dates

Study start: 2006
Primary completion: 2008
Study completion: 2008
First posted: Mar 21, 2006
Registry last updated: Feb 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed