NCT01354756

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2010

Shorter than P25 for all trials

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

May 6, 2011

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 17, 2011

Completed
Last Updated

March 10, 2015

Status Verified

March 1, 2015

Enrollment Period

7 months

First QC Date

May 6, 2011

Last Update Submit

March 9, 2015

Conditions

Keywords

sleep apneapolysomnographyobesitybariatric surgery

Outcome Measures

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.

    2 weeks

Study Arms (1)

bariatric population

obese patients in whom a bariatric surgery is planified

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Sleep Apnea SyndromesObesity

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Marie Bruyneel, MD

    CHU St Pierre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chef de Clinique

Study Record Dates

First Submitted

May 6, 2011

First Posted

May 17, 2011

Study Start

October 1, 2010

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

March 10, 2015

Record last verified: 2015-03