NCT03047941

Brief 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.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

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

First Submitted

Initial submission to the registry

February 6, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 9, 2017

Completed
4 days until next milestone

Study Start

First participant enrolled

February 13, 2017

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2022

Completed
Last Updated

January 13, 2020

Status Verified

January 1, 2020

Enrollment Period

5.6 years

First QC Date

February 6, 2017

Last Update Submit

January 9, 2020

Conditions

Sleep Apnea, Obstructive

Outcome Measures

Primary Outcomes (4)

  • Adequacy of STOP-Bang to detect severe hypoxemic OSA patients

    Adequacy of STOP-Bang after comparison with the results of the PSG.

    One week.

  • Adequacy of P-SAP to detect severe hypoxemic OSA patients

    Adequacy of P-SAP after comparison with the results of the PSG.

    One week

  • Adequacy of OSA50 to detect severe hypoxemic OSA patients

    Adequacy of OSA50 after comparison with the results of the PSG.

    One week

  • Adequacy of DES-OSA to detect severe hypoxemic OSA patients

    Adequacy of DES-OSA after comparison with the results of the PSG.

    One week

Study Arms (1)

All patients

All patients included in the present study

Diagnostic Test: Determination of optimal cutoff values.

Interventions

Determination of optimal cutoff values.DIAGNOSTIC_TEST

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.

All patients

Eligibility Criteria

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

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

You may qualify if:

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

You may not qualify if:

  • Patients \< 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ASTES

Bouge, Namur, 5001, Belgium

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases
0

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 Investigators

Study Record Dates

First Submitted

February 6, 2017

First Posted

February 9, 2017

Study Start

February 13, 2017

Primary Completion

September 30, 2022

Study Completion

October 31, 2022

Last Updated

January 13, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)