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

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.

Study Overview

• Status: Terminated
• Conditions: Sleep Apnea Syndrome

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 Type: Observational
• Enrollment (Actual): 9

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

obese patients, > 18y old, in whom a bariatric surgery is planified and who have to undergo a polysomnography for OSA screening

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
bariatric population; obese patients in whom a bariatric surgery is planified

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Saint Pierre

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): May 1, 2011
• Study Completion (Actual): May 1, 2011

Study Registration Dates

• First Submitted: May 6, 2011
• First Submitted That Met QC Criteria: May 16, 2011
• First Posted (Estimate): May 17, 2011

Study Record Updates

• Last Update Posted (Estimate): March 10, 2015
• Last Update Submitted That Met QC Criteria: March 9, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: polysomnography; obesity; bariatric surgery; sleep apnea
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Disease; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Syndrome; Apnea
• Other Study ID Numbers: AK/10-09-3921/52