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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

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01354756
Enrollment
9
Registered
2011-05-17
Start date
2010-10-31
Completion date
2011-05-31
Last updated
2015-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep Apnea Syndrome

Keywords

sleep apnea, polysomnography, obesity, bariatric surgery

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.

Interventions

None listed

Sponsors

Centre Hospitalier Universitaire Saint Pierre
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime 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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026