Effect of Endoscopic Gastric Balloon Insertion on Obstructive Sleep Apnea in Patients With Morbid Obesity
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Purpose
To investigate the effect of weight loss by gastric balloon insertion on parameters of obstructive sleep apnea.
| Condition | Intervention |
|---|---|
|
Morbid Obesity Obstructive Sleep Apnea |
Procedure: gastric balloon insertion |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Effect of Endoscopic Gastric Balloon Insertion on Obstructive Sleep Apnea in Patients With Morbid Obesity |
- effect of gastric balloon on sleep apnea [ Time Frame: 2 years ] [ Designated as safety issue: No ]
| Enrollment: | 60 |
| Study Start Date: | March 2006 |
| Study Completion Date: | September 2008 |
| Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Procedure: gastric balloon insertion
patient would be offered endoscopic gastric balloon insertion
Other Name: gastric balloon
|
Detailed Description:
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
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
More Information
No publications provided
| Responsible Party: | Doctor, CUHK |
| ClinicalTrials.gov Identifier: | NCT00305032 History of Changes |
| Other Study ID Numbers: | CRE-2005.399 |
| Study First Received: | March 20, 2006 |
| Last Updated: | January 29, 2009 |
| Health Authority: | Hong Kong: Ethics Committee |
Additional relevant MeSH terms:
|
Apnea Obesity Obesity, Morbid Sleep Apnea Syndromes Sleep Apnea, Obstructive Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory Signs and Symptoms |
Overnutrition Nutrition Disorders Overweight Body Weight Sleep Disorders, Intrinsic Dyssomnias Sleep Disorders Nervous System Diseases |
ClinicalTrials.gov processed this record on May 22, 2013