Effect of Endoscopic Gastric Balloon Insertion on Obstructive Sleep Apnea in Patients With Morbid Obesity
| Tracking Information | |||||
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| First Received Date ICMJE | March 20, 2006 | ||||
| Last Updated Date | January 29, 2009 | ||||
| Start Date ICMJE | March 2006 | ||||
| Primary Completion Date | July 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
effect of gastric balloon on sleep apnea [ Time Frame: 2 years ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
qaulity of life, Epworth Sleepiness Scales, Weight, parameters of sleep studies | ||||
| Change History | Complete list of historical versions of study NCT00305032 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effect of Endoscopic Gastric Balloon Insertion on Obstructive Sleep Apnea in Patients With Morbid Obesity | ||||
| Official Title ICMJE | Effect of Endoscopic Gastric Balloon Insertion on Obstructive Sleep Apnea in Patients With Morbid Obesity | ||||
| Brief Summary | To investigate the effect of weight loss by gastric balloon insertion on parameters of obstructive sleep apnea. |
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| 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 |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | Procedure: gastric balloon insertion
patient would be offered endoscopic gastric balloon insertion
Other Name: gastric balloon |
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| Study Arm (s) | Experimental: 1
Intervention: Procedure: gastric balloon insertion |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 60 | ||||
| Completion Date | September 2008 | ||||
| Primary Completion Date | July 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | China | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00305032 | ||||
| Other Study ID Numbers ICMJE | CRE-2005.399 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Doctor, CUHK | ||||
| Study Sponsor ICMJE | Chinese University of Hong Kong | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Chinese University of Hong Kong | ||||
| Verification Date | January 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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