Development and validation of a screening instrument for Obstructive Sleep Apnea Syndrome in healthy workers

Completed

• Conditions: Disturbed breathing; Obstructive Sleep Apnea; 10046304

• Registration Number: NL-OMON36722
• Lead Sponsor: Philips Electronics Nederland BV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 300

Inclusion Criteria

Subjects have to have a fixed employment contract with Philips Nederland
They have to work at either Philips Nederland gebouw VB, Eindhoven or Philips Healthcare, Best.

Exclusion Criteria

Temporary workers

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameters are sensitivity, specificity, positive and negative<br /><br>predictive values, and ROC Area Under the Curve. These will be calculated for<br /><br>each of the questionnaires and for all individual questions separately (step<br /><br>1), and home screening by airflow registration with the RU sleeping device<br /><br>(step 2). Home PSG with the ALICE PDX, combined with answers on sleepiness, is<br /><br>the gold standard.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary parameters are the estimated prevalence of OSAS in a healthy worker<br /><br>population, the completion rate of the questionnaires and the participation<br /><br>rate in the home screening by airflow registration with the RU sleeping device<br /><br>and home PSG with the ALICE PDX.</p><br>