Validation of Apnea LinkTM for Sleep Apnea Syndrome Screening in a Bariatric Population
|ClinicalTrials.gov Identifier: NCT01354756|
Recruitment Status : Terminated (device was stolen)
First Posted : May 17, 2011
Last Update Posted : March 10, 2015
|Condition or disease|
|Sleep Apnea Syndrome|
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.
monocentric and prospective study
- 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
- 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.
|Study Type :||Observational|
|Actual Enrollment :||9 participants|
|Official Title:||Validation of Apnea LinkTM (ResMed Corporation, Poway, California) for Sleep Apnea Syndrome Screening in a Bariatric Population|
|Study Start Date :||October 2010|
|Actual Primary Completion Date :||May 2011|
|Actual Study Completion Date :||May 2011|
obese patients in whom a bariatric surgery is planified
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01354756
|Principal Investigator:||Marie Bruyneel, MD||CHU St Pierre|