- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03570580
Inter Scorers Agreement for OSA Screening Scores.
June 6, 2019 updated by: Eric DEFLANDRE, MD, PhD, FCCP, FAHA, Astes
Four scores are usually performed to detect OSA (Obstructive Sleep Apnea) patients.
These four scores are: STOP-Bang, P-SAP, OSA50 and DES-OSA.
These scores have been previously validated.
However, a comparison between scorers in the realization of these scores has never been performed.
Study Overview
Detailed Description
Four scores are usually performed to detect OSA (Obstructive Sleep Apnea) patients.
These four scores are: STOP-Bang, P-SAP, OSA50 and DES-OSA.
These scores have been previously validated.
However, a comparison between scorers in the realization of these scores has never been performed.
The aim of this study was to evaluate this agreement using statistical methods.
Study Type
Observational
Enrollment (Actual)
191
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
-
-
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Namur, Belgium, 5004
- Clinique Saint-Luc Bouge
-
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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
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
For all the patients include in the study, the four scores (STOP-Bang, P-SAP, OSA50, and DES-OSA) will be performed several times by various scorers.
The agreement between scorers will be statistically evaluated.
Description
Inclusion Criteria:
- All preoperative patients in the Cabinet Medical ASTES
Exclusion Criteria:
- Patient's refusal
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 |
|---|---|
|
Main Group - OSA Scoring
All patients include in this study for whom the four OSA scoring will be evaluated
|
OSA scoring (four scores: STOP-Bang, P-SAP, OSA50, DES-OSA were performed by several scorers on each patients, after what agreement between scores will be evaluated).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
OSA Scoring
Time Frame: 2 months
|
Should the inter-scorers agreement between OSA scoring be accurate?
|
2 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
July 1, 2018
Primary Completion (Actual)
September 30, 2018
Study Completion (Actual)
December 31, 2018
Study Registration Dates
First Submitted
June 16, 2018
First Submitted That Met QC Criteria
June 16, 2018
First Posted (Actual)
June 27, 2018
Study Record Updates
Last Update Posted (Actual)
June 7, 2019
Last Update Submitted That Met QC Criteria
June 6, 2019
Last Verified
June 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SEED-COMP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
Undecided
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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