ClinicalTrials.Veeva

Menu

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

C

Centre Hospitalier Universitaire Saint Pierre

Status

Terminated

Conditions

Sleep Apnea Syndrome

Study type

Observational

Funder types

Other

Identifiers

NCT01354756
AK/10-09-3921/52

Details and patient eligibility

About

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.

Full 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.

Enrollment

9 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

9 participants in 1 patient group

bariatric population
Description:
obese patients in whom a bariatric surgery is planified

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems