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

NCT ID: NCT01354756

Last Updated: 2015-03-10

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 9 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2011-05-31

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.

Conditions

Sleep Apnea Syndrome

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

bariatric population

obese patients in whom a bariatric surgery is planified

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire Saint Pierre

OTHER

Sponsor Role: lead

Responsible Party

Marie Bruyneel

Chef de Clinique

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marie Bruyneel, MD

Role: PRINCIPAL_INVESTIGATOR

CHU St Pierre

Other Identifiers

AK/10-09-3921/52

Identifier Type: -

Identifier Source: org_study_id