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
  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

Resource links provided by NLM:


Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:
  • 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
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00305032

Locations
China
Prince of Wales Hospital
Hong Kong, China
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
Principal Investigator: To K Wang, FHKCP, FACCP Prince of Wales Hospital
  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:
Obesity
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Obesity, Morbid
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on October 16, 2014