Validation of Apnea LinkTM for Sleep Apnea Syndrome Screening in a Bariatric Population

Overview

Sleep apnea syndrome (OSA) frequently occurs in obese population undergoing bariatric surgery. There is a need for alternative screening tools for sleep apnea detection in the pre-operative period. The investigators would like to compare ApneaLink and complete polysomnography in this population.

Full Title of Study: “Validation of Apnea LinkTM (ResMed Corporation, Poway, California) for Sleep Apnea Syndrome Screening in a Bariatric Population”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: May 2011

Detailed Description

OSA can occur in up to 78% of patients undergoing bariatric surgery(1). Moderate to severe case will benefit from CPAP therapy, that can help avoiding post-operative complications(2). In this population, the investigators propose complete attended in-hospital polysomnography (PSG)in patients with a clinical high probability of OSA. According to obesity epidemics (3), waiting list for PSG in sleep labs is every day longer. The investigators want to assess sensitivity and specificity of a new portable screening tool, ApneaLink, to detect OSA in a bariatric population. Design: monocentric and prospective study Methods: Patients: – OSA suspicion based on : – symptoms and signs (snoring, apneas , neck circumference >38 (women) or 43cm (men)) – BMI > 50 – BMI > 40, > 40 y – BMI > 35, men, hypertension – increased serum Bicarbonate – Polyglobulia Measurements – Polysomnography in sleep lab with concommitant recording performed with Apnea LinkTM (nasal flow and oxymétry recording). – between 2 weeks : recording performed with Apnea LinkTM (nasal flow and oxymétry recording)at home.

Arms, Groups and Cohorts

  • bariatric population
    • obese patients in whom a bariatric surgery is planified

Clinical Trial Outcome Measures

Primary Measures

  • Number of patients with correct diagnosis of OSA with ApneaLink. Therefore, we will compare apnea-hypopnea index measured with ApneaLink with apnea-hypopnea index measured during polysomnography.
    • Time Frame: 2 weeks

Participating in This Clinical Trial

Inclusion Criteria

  • obese patients – > 18 years old – in whom a bariatric surgery is planified and who have to undergo a polysomnography for OSA screening Exclusion Criteria:

  • pulmonary, neurologic, neuromuscular disease – < 18 years old

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Centre Hospitalier Universitaire Saint Pierre
  • Provider of Information About this Clinical Study
    • Principal Investigator: Marie Bruyneel, Chef de Clinique – Centre Hospitalier Universitaire Saint Pierre
  • Overall Official(s)
    • Marie Bruyneel, MD, Principal Investigator, CHU St Pierre

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