Validation of Apnea LinkTM for Sleep Apnea Syndrome Screening in a Bariatric Population
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Purpose
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.
| Condition |
|---|
|
Sleep Apnea Syndrome |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Validation of Apnea LinkTM (ResMed Corporation, Poway, California) for Sleep Apnea Syndrome Screening in a Bariatric Population |
- 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. [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 9 |
| Study Start Date: | October 2010 |
| Estimated Study Completion Date: | October 2012 |
| Estimated Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
bariatric population
obese patients in whom a bariatric surgery is planified
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
obese patients, > 18y old, in whom a bariatric surgery is planified and who have to undergo a polysomnography for OSA screening
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
Contacts and Locations More Information
No publications provided
| Responsible Party: | Marie Bruyneel, MD, CHU St Pierre |
| ClinicalTrials.gov Identifier: | NCT01354756 History of Changes |
| Other Study ID Numbers: | AK/10-09-3921/52 |
| Study First Received: | May 6, 2011 |
| Last Updated: | May 16, 2011 |
| Health Authority: | Belgium: Ethics Committee |
Keywords provided by Centre Hospitalier Universitaire Saint Pierre:
|
sleep apnea polysomnography obesity bariatric surgery |
Additional relevant MeSH terms:
|
Apnea Sleep Apnea Syndromes Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory |
Signs and Symptoms Sleep Disorders, Intrinsic Dyssomnias Sleep Disorders Nervous System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013