Inter Scorers Agreement for OSA Screening Scores. | NCT03570580

Studies
Inter Scorers Agreement for OSA Screening Scores.

NCT03570580

Sponsor

Astes

Status

Completed

Last Update Posted

Jun 7, 2019Actual

Enrollment

191Actual

Phase

Not provided

Conditions

Sleep Apnea, Obstructive

Interventions

OSA scoring

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2018Actual

Primary Completion Date

Sep 30, 2018Actual

Completion Date

Dec 31, 2018Actual

First Submitted Date

Jun 16, 2018

First Submission Date that Met QC Criteria

Jun 16, 2018

First Posted Date

Jun 27, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 6, 2019

Last Update Posted Date

Jun 7, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

2 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

191Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Main Group - OSA Scoring		All patients include in this study for whom the four OSA scoring will be evaluated	Other: OSA scoring

Interventions

Name	Type	Description	Arm Group Labels	Other Names
OSA scoring	Other	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).

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
OSA Scoring	Should the inter-scorers agreement between OSA scoring be accurate?	2 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All preoperative patients in the Cabinet Medical ASTES

Exclusion Criteria:

Patient's refusal

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Eric Deflandre, MD, PhD	Astes	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clinique Saint-Luc Bouge		Namur		5004	Belgium

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Undecided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020181	Sleep Apnea, Obstructive
D012891	Sleep Apnea Syndromes

Ancestor Terms

ID	Term
D001049	Apnea
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D020919	Sleep Disorders, Intrinsic

Browse Leaves

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Browse Branches

Not provided