Derivation and Validation of a Combination of BOSTON Score and DES-OSA Score for Selection of OSA Patients.

Obstructive Sleep Apnea Clinical Trial

Official title:

Derivation and Validation of a Combination of BOSTON Score and DES-OSA Score for Selection of OSA Patients. A Preliminary Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03983564
• Other study ID #: PS-PSG
• Status: Completed
• Start date: September 1, 2021
• Est. completion date: October 31, 2021

Study information

• Verified date: February 2022
• Source: Astes
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

The aim of this study is to derive and to validate a combination of BOSTON score and DES-OSA score.

Firstly, the investigators will use a retrospective cohort of 400 patients to determine this combination. It will allow classifying patients in 3 groups: 1) patients for whom OSA can be excluded with certitude, 2) patients for whom OSA can be diagnosed with certitude, and 3) an intermediate group.

Secondly, the 100 patients included in this study will serve to validate the cutoff of the abovementioned combination into a new population.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 31, 2021
• Est. primary completion date: October 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Patient's refusal

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea, Obstructive

Intervention

Other:
• Cutoff Validation
We will validate the cutoff of the combination of BOSTON score and DES-OSA scores with the result of a polysomnography.

Locations

Country	Name	City	State
Belgium	Clinique Saint-Luc de Bouge	Bouge	Namur

Sponsors (1)

Lead Sponsor	Collaborator
Astes

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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