Influence of Different Methods of Measurement in the Accuracy of DES-OSA and P-SAP Scores

November 13, 2018 updated by: Eric DEFLANDRE, MD, PhD, FCCP, Astes

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1682

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Namur
      • Bouge, Namur, Belgium, 5004
        • Clinique Saint-Luc of Bouge

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients scheduled for an anesthetic preoperative consultation

Description

Inclusion Criteria:

  • All patients scheduled for an anesthetic preoperative consultation

Exclusion Criteria:

  • < 18 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Comparison of accuracy of DES-OSA and P-SAP scores with the result of the PSG (polysomnography)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy of DES-OSA
Time Frame: one month
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
Time Frame: one month
Accuracy of different values of P-SAP (due to different measurement of neck circumference) with the result of PSG.
one month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2016

Primary Completion (ACTUAL)

September 30, 2018

Study Completion (ACTUAL)

October 31, 2018

Study Registration Dates

First Submitted

February 7, 2017

First Submitted That Met QC Criteria

February 8, 2017

First Posted (ESTIMATE)

February 9, 2017

Study Record Updates

Last Update Posted (ACTUAL)

November 14, 2018

Last Update Submitted That Met QC Criteria

November 13, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NC-DTC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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