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

Development and validation of a screening instrument for Obstructive Sleep Apnea Syndrome in healthy workers - Developing a screeing test for OSAS

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON36722

Enrollment

300

Registered

2011-02-08

Start date

2011-02-11

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Disturbed breathing Obstructive Sleep Apnea

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: Temporary workers

Design outcomes

Primary

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

Measure

Time frame

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

—

Secondary

Measure	Time frame
Secondary parameters are the estimated prevalence of OSAS in a healthy worker population, the completion rate of the questionnaires and the participation rate in the home screening by airflow registration with the RU sleeping device and home PSG with the ALICE PDX.	—

Countries

Netherlands

Outcome results