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

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

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

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: Other: Cutoff Validation

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Belgium
  • Namur
    • Bouge, Namur, Belgium, 5004
      • Clinique Saint-Luc de Bouge

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Population to validate the cutoff of the combination of scores

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Patient's refusal

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; We will validate the cutoff of the combination of BOSTON score and DES-OSA scores with the result of a polysomnography.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Astes
• Investigators: Principal Investigator: Eric Deflandre, MD, PhD, Clinique Saint-Luc of Bouge

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Actual): October 31, 2021
• Study Completion (Actual): October 31, 2021

Study Registration Dates

• First Submitted: June 6, 2019
• First Submitted That Met QC Criteria: June 8, 2019
• First Posted (Actual): June 12, 2019

Study Record Updates

• Last Update Posted (Actual): February 24, 2022
• Last Update Submitted That Met QC Criteria: February 14, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
• Other Study ID Numbers: PS-PSG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No sharing

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No