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

This study has been completed.
Sponsor:
Information provided by:
Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT00305032
First received: March 20, 2006
Last updated: January 29, 2009
Last verified: January 2009

March 20, 2006
January 29, 2009
March 2006
July 2008   (final data collection date for primary outcome measure)
effect of gastric balloon on sleep apnea [ Time Frame: 2 years ] [ Designated as safety issue: No ]
qaulity of life, Epworth Sleepiness Scales, Weight, parameters of sleep studies
Complete list of historical versions of study NCT00305032 on ClinicalTrials.gov Archive Site
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Effect of Endoscopic Gastric Balloon Insertion on Obstructive Sleep Apnea in Patients With Morbid Obesity
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.

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

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Morbid Obesity
  • Obstructive Sleep Apnea
Procedure: gastric balloon insertion
patient would be offered endoscopic gastric balloon insertion
Other Name: gastric balloon
Experimental: 1
Intervention: Procedure: gastric balloon insertion
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
September 2008
July 2008   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00305032
CRE-2005.399
Yes
Doctor, CUHK
Chinese University of Hong Kong
Not Provided
Principal Investigator: To K Wang, FHKCP, FACCP Prince of Wales Hospital
Chinese University of Hong Kong
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP