Effect of Endoscopic Gastric Balloon Insertion on Obstructive Sleep Apnea in Patients With Morbid Obesity
Primary Purpose
Morbid Obesity, Obstructive Sleep Apnea
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
gastric balloon insertion
Sponsored by
About this trial
This is an interventional treatment trial for Morbid Obesity
Eligibility Criteria
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
Sites / Locations
- Prince of Wales Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
effect of gastric balloon on sleep apnea
Secondary Outcome Measures
Full Information
NCT ID
NCT00305032
First Posted
March 20, 2006
Last Updated
February 26, 2016
Sponsor
Chinese University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT00305032
Brief Title
Effect of Endoscopic Gastric Balloon Insertion on Obstructive Sleep Apnea in Patients With Morbid Obesity
Official Title
Effect of Endoscopic Gastric Balloon Insertion on Obstructive Sleep Apnea in Patients With Morbid Obesity
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
September 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To investigate the effect of weight loss by gastric balloon insertion on parameters of obstructive sleep apnea.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity, Obstructive Sleep Apnea
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
gastric balloon insertion
Other Intervention Name(s)
gastric balloon
Intervention Description
patient would be offered endoscopic gastric balloon insertion
Primary Outcome Measure Information:
Title
effect of gastric balloon on sleep apnea
Time Frame
2 years
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
To K Wang, FHKCP, FACCP
Organizational Affiliation
Prince of Wales Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prince of Wales Hospital
City
Hong Kong
State/Province
Hong Kong
Country
China
12. IPD Sharing Statement
Learn more about this trial
Effect of Endoscopic Gastric Balloon Insertion on Obstructive Sleep Apnea in Patients With Morbid Obesity
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