NCT02050685

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
159

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2014

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

Study Start

First participant enrolled

January 1, 2014

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

January 24, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 31, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

January 6, 2016

Status Verified

January 1, 2016

Enrollment Period

1.9 years

First QC Date

January 24, 2014

Last Update Submit

January 5, 2016

Conditions

Sleep Apnea, Obstructive

Outcome Measures

Primary Outcomes (1)

  • Comparison of the DES-OSA score with previously described scores.

    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 Outcomes (1)

  • Comparison of the four screening scores with results of the PSG.

    The day after the polysomnography

Study Arms (1)

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.

Other: All patients incoming in the sleep study centre for a PSG

Interventions

All patients incoming in the sleep study centre for a PSGOTHER

All patients incoming in the sleep study centre for a PSG. Comparison between screening score and AHI derived from PSG.

All patients for PSG at SLBO

Eligibility Criteria

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

All adults patients for an overnight polysomnography at SLBO.

You may qualify if:

  • Adults patients (\> 18 years)

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinique Saint-Luc de Bouge

Bouge, Namur, 5004, Belgium

Location

Related Publications (1)

  • Deflandre E, Piette N, Bonhomme V, Degey S, Cambron L, Poirrier R, Brichant JF, Joris J. Comparison of clinical scores in their ability to detect hypoxemic severe OSA patients. PLoS One. 2018 May 7;13(5):e0196270. doi: 10.1371/journal.pone.0196270. eCollection 2018.

    PMID: 29734398DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

  • Eric P DEFLANDRE, MD, FCCP

    Astes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
ERIC DEFLANDRE, MD, FCCP

Study Record Dates

First Submitted

January 24, 2014

First Posted

January 31, 2014

Study Start

January 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

January 6, 2016

Record last verified: 2016-01

Locations

BE(1)