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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00305032
Recruitment Status : Completed
First Posted : March 21, 2006
Last Update Posted : February 29, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
To investigate the effect of weight loss by gastric balloon insertion on parameters of obstructive sleep apnea.

Condition or disease Intervention/treatment
Morbid Obesity Obstructive Sleep Apnea Procedure: gastric balloon insertion

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


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Endoscopic Gastric Balloon Insertion on Obstructive Sleep Apnea in Patients With Morbid Obesity
Study Start Date : March 2006
Primary Completion Date : July 2008
Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1 Procedure: gastric balloon insertion
patient would be offered endoscopic gastric balloon insertion
Other Name: gastric balloon


Outcome Measures

Primary Outcome Measures :
  1. effect of gastric balloon on sleep apnea [ Time Frame: 2 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00305032


Locations
China, Hong Kong
Prince of Wales Hospital
Hong Kong, 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

Responsible Party: To Kin Wang, Doctor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT00305032     History of Changes
Other Study ID Numbers: CRE-2005.399
First Posted: March 21, 2006    Key Record Dates
Last Update Posted: February 29, 2016
Last Verified: February 2016

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 Wake Disorders
Nervous System Diseases