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NCT03047941 Clinical Trial

Determination of Optimal Cutoff Value for Screening Severe Hypoxemic OSA (Obstructive Sleep Apnea) Patients

Sleep Apnea, Obstructive Clinical Trial

Official title:
Determination of Optimal Cutoff Value of 4 Tests (DES-OSA, STOP-Bang, OSA50, P-SAP) for Screening Severe Hypoxemic OSA (Obstructive Sleep Apnea) Patients

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT03047941
Other study ID # REES2
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date February 13, 2017
Est. completion date October 31, 2022

Study information
Verified date January 2020
Source Astes
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The 4 following scores have been proposed to detect OSA (Obstructive Sleep Apnea): DES-OSA, STOP-Bang, P-SAP, and OSA50.

The aim of this study is to evaluate the optimal cutoff value of these four scores to detect specifically serve OSA patients with hypoxemia.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date October 31, 2022
Est. primary completion date September 30, 2022
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- All patients scheduled to have a PSG in the sleep laboratory center.

Exclusion Criteria:

- Patients < 18 years

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Determination of optimal cutoff values.
The results of the four scores will be compared with the results of the polysomnography (PSG). A statistical analysis will be performed to determine the optimal cutoff value of each of the four scores to detect severe OSA patient with hypoxemia.

Locations
Country Name City State
Belgium ASTES Bouge Namur

Sponsors (1)
Lead Sponsor Collaborator
Astes

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary Adequacy of STOP-Bang to detect severe hypoxemic OSA patients Adequacy of STOP-Bang after comparison with the results of the PSG. One week.
Primary Adequacy of P-SAP to detect severe hypoxemic OSA patients Adequacy of P-SAP after comparison with the results of the PSG. One week
Primary Adequacy of OSA50 to detect severe hypoxemic OSA patients Adequacy of OSA50 after comparison with the results of the PSG. One week
Primary Adequacy of DES-OSA to detect severe hypoxemic OSA patients Adequacy of DES-OSA after comparison with the results of the PSG. One week
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