Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2025-12-25 @ 9:21 PM
Study NCT ID:
NCT01354756
Status:
TERMINATED
Last Update Posted:
2015-03-10
First Post:
2011-05-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Validation of Apnea LinkTM for Sleep Apnea Syndrome Screening in a Bariatric Population
Sponsor:
Centre Hospitalier Universitaire Saint Pierre
Organization:
Study Overview
Official Title:
Validation of Apnea LinkTM (ResMed Corporation, Poway, California) for Sleep Apnea Syndrome Screening in a Bariatric Population
Status:
TERMINATED
Status Verified Date:
2015-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
device was stolen
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: