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

NCT ID: NCT00305032

Last Updated: 2016-02-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-03-31
• Study Completion Date: 2008-09-30

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

Conditions

Morbid Obesity; Obstructive Sleep Apnea

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

gastric balloon insertion

Intervention Type: PROCEDURE

patient would be offered endoscopic gastric balloon insertion

Interventions

gastric balloon insertion

patient would be offered endoscopic gastric balloon insertion

Intervention Type: PROCEDURE

Other Intervention Names

gastric balloon

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

To Kin Wang

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

To K Wang, FHKCP, FACCP

Role: PRINCIPAL_INVESTIGATOR

Prince of Wales Hospital

Locations

Prince of Wales Hospital

Hong Kong, Hong Kong, China

Countries

China

Other Identifiers

CRE-2005.399

Identifier Type: -

Identifier Source: org_study_id