NCT03983564

Brief Summary

Derivation and Validation of a combination of BOSTON score and DES-OSA score to exclude OSA or to confirm OSA in patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2021

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 6, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 12, 2019

Completed
2.2 years until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2021

Completed
Last Updated

February 24, 2022

Status Verified

February 1, 2022

Enrollment Period

2 months

First QC Date

June 6, 2019

Last Update Submit

February 14, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Validation of cutoff values for the combination of BOSTON score and DES-OSA score in order to classify patients following their risk to present an OSA Syndrome.

    Validation of cutoff values for the combination of BOSTON score and DES-OSA score derived in the retrospective group in order to validate these cutoff values in order to classify patients following their risk to present an OSA (Obstructive Sleep Apnea) Syndrome. The measurements will serve to validate the classification establish in the retrospective study, namely 1) patients without OSA with certitude, 2) patients with OSA with certitude, 3) an intermediate category.

    One month

Study Arms (1)

All patients

Patients in this group will serve to validate the cutoff of the combination of the DES-OSA and BOSTON scores derived in the retrospective group.

Other: Cutoff Validation

Interventions

We will validate the cutoff of the combination of BOSTON score and DES-OSA scores with the result of a polysomnography.

All patients

Eligibility Criteria

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

Population to validate the cutoff of the combination of scores

You may qualify if:

  • All patients admitted in the Clinique Saint-Luc of Bouge for a polysomnography

You may not qualify if:

  • Patient's refusal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinique Saint-Luc de Bouge

Bouge, Namur, 5004, Belgium

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

  • Eric Deflandre, MD, PhD

    Clinique Saint-Luc of Bouge

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

June 6, 2019

First Posted

June 12, 2019

Study Start

September 1, 2021

Primary Completion

October 31, 2021

Study Completion

October 31, 2021

Last Updated

February 24, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

No sharing

Locations