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

Sleep Apnea Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01354756
• Other study ID #: AK/10-09-3921/52
• Status: Terminated
• Phase: N/A
• First received: May 6, 2011
• Last updated: March 9, 2015
• Start date: October 2010
• Est. completion date: May 2011

Study information

• Verified date: March 2015
• Source: Centre Hospitalier Universitaire Saint Pierre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Apnea
• Sleep Apnea Syndrome
• Sleep Apnea Syndromes
• Syndrome

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Saint Pierre

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No