Clinical Trials Directory

Trials / Terminated

TerminatedNCT01354756

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

Validation of Apnea LinkTM (ResMed Corporation, Poway, California) for Sleep Apnea Syndrome Screening in a Bariatric Population

Status
Terminated
Phase
Study type
Observational
Enrollment
9 (actual)
Sponsor
Centre Hospitalier Universitaire Saint Pierre · Academic / Other
Sex
All
Age
18 Years – 80 Years
Healthy volunteers
Not accepted

Summary

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.

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.

Conditions

Timeline

Start date
2010-10-01
Primary completion
2011-05-01
Completion
2011-05-01
First posted
2011-05-17
Last updated
2015-03-10

Source: ClinicalTrials.gov record NCT01354756. Inclusion in this directory is not an endorsement.