NCT03570580

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
191

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

June 16, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 27, 2018

Completed
4 days until next milestone

Study Start

First participant enrolled

July 1, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

June 7, 2019

Status Verified

June 1, 2019

Enrollment Period

3 months

First QC Date

June 16, 2018

Last Update Submit

June 6, 2019

Conditions

Sleep Apnea, Obstructive

Keywords

Sleep Apnea, Obstructive, Mass Screening

Outcome Measures

Primary Outcomes (1)

  • OSA Scoring

    Should the inter-scorers agreement between OSA scoring be accurate?

    2 months

Study Arms (1)

Main Group - OSA Scoring

All patients include in this study for whom the four OSA scoring will be evaluated

Other: OSA scoring

Interventions

OSA scoringOTHER

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).

Main Group - OSA Scoring

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • All preoperative patients in the Cabinet Medical ASTES

You may not qualify if:

  • Patient's refusal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinique Saint-Luc Bouge

Namur, 5004, Belgium

Location

MeSH Terms

Conditions

Sleep Apnea, ObstructiveSleep Apnea Syndromes

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Eric Deflandre, MD, PhD

    Astes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Department

Study Record Dates

First Submitted

June 16, 2018

First Posted

June 27, 2018

Study Start

July 1, 2018

Primary Completion

September 30, 2018

Study Completion

December 31, 2018

Last Updated

June 7, 2019

Record last verified: 2019-06

Locations

BE(1)