NCT02051829

Brief Summary

Comparison of preoperative screening score for OSA. In a preoperative population, comparison of the STOP-BANG, DES-OSA, P-SAP and OSA50 score.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,584

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2014

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

January 24, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 31, 2014

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

April 22, 2016

Status Verified

April 1, 2016

Enrollment Period

2.2 years

First QC Date

January 24, 2014

Last Update Submit

April 21, 2016

Conditions

Sleep Apnea, Obstructive

Outcome Measures

Primary Outcomes (1)

  • Number of patients with a positive DES-OSA score

    Comparison of the result of the DES-OSA score with results of previously describes scores (STOP-BANG, OSA50 and P-SAP).

    Baseline

Secondary Outcomes (1)

  • Number of patients with a positive STOP-Bang score and a positive PSG (PolySomnoGraphy)

    Baseline

Study Arms (1)

All patients

Comparison of the four screening score

Other: Comparison of the four screening score

Interventions

Comparison of the four screening scoreOTHER

Comparison of the four screening score, for patient making a preoperative assessment for SLBO (clinique Saint-Luc de BOuge)

All patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients (\> 18 years) presenting for preoperative assessment before surgery at SLBO.

You may qualify if:

  • All adults patients (\> 18 years) performing a preoperative assessment at the ASTES Doctor's Office (ASTES is an acronym with the name of Medical Doctors involved in this office)

You may not qualify if:

  • Patients \< 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cabinet Medical ASTES

Jambes, Jambes, 5100, Belgium

Location

Related Publications (1)

  • Deflandre E, Degey S, Brichant JF, Donneau AF, Frognier R, Poirrier R, Bonhomme V. Pre-Operative Ability of Clinical Scores to Predict Obstructive Sleep Apnea (OSA) Severity in Susceptible Surgical Patients. Obes Surg. 2017 Mar;27(3):716-729. doi: 10.1007/s11695-016-2352-4.

    PMID: 27599985DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Eric P DEFLANDRE, MD, FCCP

    Astes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Eric DEFLANDRE, MD, FCCP

Study Record Dates

First Submitted

January 24, 2014

First Posted

January 31, 2014

Study Start

January 1, 2014

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

April 22, 2016

Record last verified: 2016-04

Locations

BE(1)