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TerminatedNCT01354756Updated Mar 10, 2015

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

An observational study in Sleep Apnea Syndrome, sponsored by Centre Hospitalier Universitaire Saint Pierre. Terminated. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2015-03-10.

Sponsored by Centre Hospitalier Universitaire Saint Pierre · Observational

Why this study was terminated
device was stolen
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
9
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Sleep Apnea Syndrome

Keywords

  • sleep apnea
  • polysomnography
  • obesity
  • bariatric surgery
03

In context

Apnea

1,422 studies on the registry are indexed under Apnea; 159 are open to participants now.

This study's enrollment of 9 is below the median of 106 across 386 observational studies indexed under Apnea.

Browse Apnea studies →

Lead sponsor

Centre Hospitalier Universitaire Saint Pierre is the lead sponsor of 78 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
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

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

Exclusion Criteria:

  • pulmonary, neurologic, neuromuscular disease
  • \< 18 years old
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
9 participants (actual)

Groups and cohorts

  • bariatric population

    obese patients in whom a bariatric surgery is planified

06

What researchers measure

Primary outcomes

  1. 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

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 10, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01354756
Lead sponsor
Centre Hospitalier Universitaire Saint Pierre
Responsible party
Marie Bruyneel (Chef de Clinique, Centre Hospitalier Universitaire Saint Pierre) — Principal investigator
First posted
May 17, 2011
Start date
Oct 2010
Primary completion
May 2011
Completion
May 2011
Last update
Mar 10, 2015

Study contacts

Marie Bruyneel, MD
principal investigator · CHU St Pierre

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.

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