- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02050685
Comparison of Different Screening Score for Hypoxemic OSA (Obstructive Sleep Apnea) With the Results of a Polysomnography (PSG)
January 5, 2016 updated by: Eric DEFLANDRE, MD, FCCP
Comparison of Different Screening Score for Hypoxemic OSA
Comparison of different screening score for hypoxemic OSA (Obstructive Sleep Apnea) with the results of a polysomnography (PSG).
The different screening score studied are: STOP-BANG, DES-OSA, P-SAP and OSA50.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The investigators should compare the four screening scores (STOP-BANG, DES-OSA, P-SAP and OSA50) with the results of the PSG (and in particular the number of apnea and hypopnea index and the probability of hypoxemia).
Study Type
Observational
Enrollment (Actual)
159
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
-
-
Namur
-
Bouge, Namur, Belgium, 5004
- Clinique Saint-Luc de 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
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
All adults patients for an overnight polysomnography at SLBO.
Description
Inclusion Criteria:
- Adults patients (> 18 years)
Exclusion Criteria:
- None
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 for PSG at SLBO
All patients incoming in the sleep study centre for a PSG.
At the arrival the screening score will be recorder.
AHI will be recorded next morning after analysis of the PSG.
|
All patients incoming in the sleep study centre for a PSG.
Comparison between screening score and AHI derived from PSG.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Comparison of the DES-OSA score with previously described scores.
Time Frame: The day before the PSG (PolySomnoGraphy)
|
Comparison of the DES-OSA score with the results of previously described scores (STOP-BANG, P-SAP and OSA50).
|
The day before the PSG (PolySomnoGraphy)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Comparison of the four screening scores with results of the PSG.
Time Frame: The day after the polysomnography
|
Comparison of the four screening scores collected past day (before PSG - PolySomnoGraphy) with the results of the PSG (especially the AHI: Apnea Hypopnea Index)
|
The day after the polysomnography
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
January 1, 2014
Primary Completion (Actual)
December 1, 2015
Study Completion (Actual)
December 1, 2015
Study Registration Dates
First Submitted
January 24, 2014
First Submitted That Met QC Criteria
January 29, 2014
First Posted (Estimate)
January 31, 2014
Study Record Updates
Last Update Posted (Estimate)
January 6, 2016
Last Update Submitted That Met QC Criteria
January 5, 2016
Last Verified
January 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REES-ASTES-2014
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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