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Validating a Novel Driving Simulation-based MWT Against the Standard MWT in an OSA-cohort Challenged by CPAP-withdrawal

RecruitingNAAges 18 Years - anyAllStefan Lakämper
NCT06872593 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

In brief, the proposed study will evaluate a recently proposed naturalistic, driving simulation test to identify and measure sleepiness behind the wheel, one of the most underestimated causes of road accidents. The proposed test offers higher ecological validity and might complement somnological tests that are standard, but rarely performed. Thus, the test might provide traffic medicine and sonologists with an effective tool, that can also directly convey the risks of excessive daytime sleepiness to drivers and thus, in combination, effectively aid in traffic medicine's mandate to avoid preventable road fatalities. Excessive daytime sleepiness (EDS) is a symptomatic condition resulting from too little or compromised sleep, caused by psycho-social stress (shiftwork, lifestyle) or medical conditions (obstructive sleep apnoea (OSA), narcolepsy). Driving with untreated EDS might lead to sle

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📋 Eligibility rules (as published)
Inclusion Criteria (OSA patients): adult drivers, diagnosed OSA, established CPAP-treatment regime, highly adherent and compliant within the last 6 months (\>5h, \>80% of days), at impaired eyesight with more than +/- 5 diopter or astigmatism, contact lenses are required (for eye tracking) Inclusion criteria (healthy comparison croup): adult drivers, no declared psychiatric disorders, no declared sleep-related diagnosis, at impaired eyesight with more than +/- 5 diopter or astigmatism, contact lenses are required (for eye tracking) Exclusion criteria (for both groups): sensibility to motion sickness (kinetosis, dizziness, etc. in 5 min screening drive), professional drivers (if working during the study period), inability to understand the study procedure for linguistic or cognitive reasons.
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What it tests

  • CPAP-withdrawal
  • Test Sequence
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Where

1 site
Division of Traffic Medicine, Institute of Forensic Medicine, University of Zurich
Zurich, Switzerland
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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