NCT03172806

Brief Summary

The aim of this study was to compare the ability of clinical scores (P-SAP, OSA50, DES-OSA, STOP-Bang with former algorithm, and STOP-Bang with new algorithm).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
293

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2016

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

August 1, 2016

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 30, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 1, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2018

Completed
Last Updated

June 19, 2018

Status Verified

June 1, 2018

Enrollment Period

1.4 years

First QC Date

May 30, 2017

Last Update Submit

June 16, 2018

Conditions

Apnea, Sleep

Outcome Measures

Primary Outcomes (1)

  • Comparison of results of clinical scores and results of polysomnography.

    Comparison of the two results to determine the sensitivity and specificity of each clinical scores in comparison with polysmnography (the gold standard).

    1 night

Study Arms (1)

Study Group

All patients included in the study. First: clinical scores were collected in all patients. Second: all patients underwent a polysomnography in order to compare this results with these of the clinical scores.

Diagnostic Test: Polysomnography

Interventions

PolysomnographyDIAGNOSTIC_TEST

To compare the ability of the clinical scores, all patients included in this study underwent a polysomnography.

Study Group

Eligibility Criteria

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

All patients enrolling in the preanesthsia visit before elective surgery.

You may qualify if:

  • All patients in the preoperative anesthesia visit between 01/08/2016 and 31/12/2017

You may not qualify if:

  • Patient's refusal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinique Saint-Luc de Bouge

Bouge, Namur, 5004, Belgium

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes

Interventions

Polysomnography

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Intervention Hierarchy (Ancestors)

Monitoring, PhysiologicDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Eric DEFLANDRE, MD, FCCP

    Astes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Investigator

Study Record Dates

First Submitted

May 30, 2017

First Posted

June 1, 2017

Study Start

August 1, 2016

Primary Completion

December 31, 2017

Study Completion

January 31, 2018

Last Updated

June 19, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)