search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Ontwikkeling en validatie van een screeningsinstrument voor Obstructief Slaap Apneu Syndroom.


- candidate number8859
- NTR NumberNTR2675
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR3-jan-2011
- Secondary IDsP10-49 METC
- Public TitleOntwikkeling en validatie van een screeningsinstrument voor Obstructief Slaap Apneu Syndroom.
- Scientific TitleDevelopment and validation of a screening instrument for Obstructive Sleep Apnea Syndrome in healthy workers.
- ACRONYMDeveloping a tool for screening OSAS
- hypothesisN/A
- Healt Condition(s) or Problem(s) studiedObstructive sleep apnea syndrome
- Inclusion criteria1. Subjects have to have a fixed employment contract with Philips Nederland;
2. Subjects have to work at either Philips Nederland gebouw VB, Eindhoven or Philips Healthcare, Best.
- Exclusion criteriaTemporary workers.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-feb-2011
- planned closingdate1-mei-2011
- Target number of participants300
- InterventionsN/A
- Primary outcomeFind the best 2 or 3 step strategy for screening of OSAS in a Dutch employee population to optimize a large scale screening program. Home PSG with the ALICE PDX, combined with answers on sleepiness will be used for confirmation. This includes the following:
1. Which questionnaire, or set of questions has the highest accuracy in terms of sensitivity, specificity and positive and negative predictive value;
2. Define the low and high cut-off values of the used questionnaires for negative and positive test results;
3. Are limited IV home sleep studies in this population feasible;
4. What is the accuracy of the complete strategy.
- Secondary outcome1. Calculate the costs of the strategy;
2. Estimate the prevalence of OSAS in this population;
3. Estimate the prevalence of Excessive Daytime Sleepiness in this population.
- TimepointsThis is a diagnostic study with measurements within two/three weeks.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIES M.M. Eijsvogel
- CONTACT for SCIENTIFIC QUERIES M.M. Eijsvogel
- Sponsor/Initiator Philips NV
- Funding
(Source(s) of Monetary or Material Support)
Philips NV
- PublicationsN/A
- Brief summaryRationale:
The Obstructive Sleep Apnea Syndrome (OSAS) is a disorder that is characterized by repetitive episodic partial or complete collapse of the pharyngeal airway. These nocturnal events interfere with normal restorative sleep and are responsible for the daytime symptoms like excessive daytime sleepiness, poor concentration and fatigue. OSAS is associated with increased cardio vascular and cerebrovascular morbidity and mortality. Philips NV Netherlands is planning to screen a large part of their Dutch work force (approximately 16.000 employees) for OSAS. Because of these large numbers a simple, but sensitive and specific screening strategy needs to be developed and tested. The proposed study will investigate and validate in a population of approximately 300 healthy workers from Philips NV a set of diagnostic questionnaires, supplemented with airflow registration with the RU sleeping device. The gold standard will be the combined result from Polysomnography (PSG), performed at home, and answers to questions on sleepiness from questionnaires.

Primary Objective(s):
Find the best 2 or 3 step strategy for screening of OSAS in a Dutch employee population to optimize a large scale screening program. Home PSG, combined with answers on sleepiness, will be used for confirmation. This includes the following:
1. Which questionnaire, or set of questions has the highest accuracy in terms of sensitivity, specificity and positive and negative predictive value;
2. Define the low and high cut-off values of the used questionnaires for negative and positive test results;
3. Are limited IV home sleep studies in this population feasible;
4. What is the accuracy of the complete strategy.

Secondary Objective(s):
1. Calculate the costs of the strategy;
2. Estimate the prevalence of OSAS in this population;
3. Estimate the prevalence of Excessive Daytime Sleepiness in this population.

Study design:
The study will be designed as a diagnostic study.

Study population:
Healthy workers from Philips NV.

Main study parameters/endpoints:
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, combined with answers on sleepiness, is the gold standard in this study.
- Main changes (audit trail)
- RECORD3-jan-2011 - 11-jan-2011


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl