NCT03047421

Brief Summary

DES-OSA and P-SAP scores have been validated to detect OSA (Obstructive Sleep Apnea). One item of P-SAP and DES-OSA is the measurement of neck circumference. The aim of this study is to compare the influence of different methods of neck circumference measurement in the accuracy of DES-OSA and P-SAP scores to detect OSA.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,682

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2016

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, 2016

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 7, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 9, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2018

Completed
Last Updated

November 14, 2018

Status Verified

November 1, 2018

Enrollment Period

2.7 years

First QC Date

February 7, 2017

Last Update Submit

November 13, 2018

Conditions

Sleep Apnea, Obstructive

Outcome Measures

Primary Outcomes (2)

  • Accuracy of DES-OSA

    Accuracy of different values of DES-OSA (due to different measurement of neck circumference) with the result of PSG.

    one month

  • Accuracy of P-SAP

    Accuracy of different values of P-SAP (due to different measurement of neck circumference) with the result of PSG.

    one month

Study Arms (1)

All patients included

For all patients scheduled for an anesthetic preoperative consultation, a comparison of accuracy of DES-OSA and P-SAP scores with PSG (polysomnography) will be performed.

Diagnostic Test: Comparison of accuracy of DES-OSA and P-SAP scores

Interventions

Comparison of accuracy of DES-OSA and P-SAP scoresDIAGNOSTIC_TEST

Comparison of accuracy of DES-OSA and P-SAP scores with the result of the PSG (polysomnography)

All patients included

Eligibility Criteria

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

All patients scheduled for an anesthetic preoperative consultation

You may qualify if:

  • All patients scheduled for an anesthetic preoperative consultation

You may not qualify if:

  • \< 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinique Saint-Luc of Bouge

Bouge, Namur, 5004, Belgium

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

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

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
Principal Investigator

Study Record Dates

First Submitted

February 7, 2017

First Posted

February 9, 2017

Study Start

January 1, 2016

Primary Completion

September 30, 2018

Study Completion

October 31, 2018

Last Updated

November 14, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)