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

Terminated

• Conditions: Sleep Apnea Syndrome

• Registration Number: NCT01354756
• Lead Sponsor: Centre Hospitalier Universitaire Saint Pierre

Brief 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.

Study Timeline

• Study Start: 2010-10
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Study First Submitted: 2011-05-06
• Study First Submitted QC: 2011-05-16
• Study First Posted: 2011-05-17
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-09
• Last Update Posted: 2015-03-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	2 weeks