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NCT03172806 Clinical Trial

Comparison of the New Algorithm of STOP-Bang in the Detection of Severe OSA Patients

Apnea, Sleep Clinical Trial

Official title:
Comparison of the New Algorithm of STOP-Bang in the Detection of Severe OSA Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03172806
Other study ID # NASB
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 1, 2016
Est. completion date January 31, 2018

Study information
Verified date June 2018
Source Astes
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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).

Description:

Severe OSA (Obstructive Sleep Apnea) patients are at higher risk of postoperative complications.

STOP-Bang has been proposed to detect OSA patients. It has been validated. New algorithm of STOP-Bang was proposed by the end of 2016. This aim of this study was to evaluate the ability of this new algorithm to detect severe OSA patients (patients with more than 30 events per hour). The new algorithm was also compared in this same ability with three others clinical score (P-SAP, OSA50 and DES-OSA).

Recruitment information / eligibility
Status Completed
Enrollment 293
Est. completion date January 31, 2018
Est. primary completion date December 31, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- Patient's refusal

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Polysomnography
To compare the ability of the clinical scores, all patients included in this study underwent a polysomnography.

Locations
Country Name City State
Belgium Clinique Saint-Luc de Bouge Bouge Namur

Sponsors (1)
Lead Sponsor Collaborator
Astes

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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Completed NCT02886156 - Effects of CPAP on Cognitive Function, Neurocognitive Architecture and Function in Patients With OSA: The SMOSAT Trial N/A