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

This study has been terminated.
(device was stolen)
Sponsor:
Information provided by:
Centre Hospitalier Universitaire Saint Pierre
ClinicalTrials.gov Identifier:
NCT01354756
First received: May 6, 2011
Last updated: May 16, 2011
Last verified: May 2011
  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

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire Saint Pierre:

Primary Outcome Measures:
  • 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
Study Population

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

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01354756

Sponsors and Collaborators
Centre Hospitalier Universitaire Saint Pierre
Investigators
Principal Investigator: Marie Bruyneel, MD CHU St Pierre
  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
Syndrome
Disease
Dyssomnias
Nervous System Diseases
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms
Signs and Symptoms, Respiratory
Sleep Disorders
Sleep Disorders, Intrinsic

ClinicalTrials.gov processed this record on October 23, 2014