Driving-simulator sleepiness test compared with the standard wakefulness test for people with OSA after pausing CPAP
Validating a Novel Driving Simulation-based MWT Against the Standard MWT in an OSA-cohort Challenged by CPAP-withdrawal - a Monocentric, Controlled, Randomized, Crossover Trial
This research will test whether a naturalistic driving-simulator sleepiness test can detect dangerous sleepiness behind the wheel in adults with obstructive sleep apnea after temporarily stopping CPAP treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 54 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Zurich Academic / other |
| Locations | 1 site (Zurich, ZRH) |
| Trial ID | NCT06872593 on ClinicalTrials.gov |
What this trial studies
Participants will include adults with diagnosed OSA who are highly adherent to CPAP and a healthy comparison group; OSA participants will undergo a controlled CPAP withdrawal. The new naturalistic driving simulation-based maintenance-of-wakefulness-like test will be compared directly with the standard MWT to see how well each identifies sleepiness and driving impairment. Eye-tracking (requiring contact lenses) and a short screening drive to exclude motion sickness will be used to capture objective indicators of drowsiness. The testing is performed in person at the Division of Traffic Medicine, University of Zurich, with strict eligibility criteria to ensure safety and valid comparisons.
Who should consider this trial
Good fit: Ideal participants are adult drivers with diagnosed OSA who have been highly adherent to CPAP (greater than 5 hours per night on >80% of nights in the past 6 months) or healthy adult drivers without sleep disorders for the comparison group.
Not a fit: Patients who are professional drivers, have severe uncorrectable vision problems, are prone to motion sickness, or cannot understand study procedures are unlikely to benefit from participating.
Why it matters
Potential benefit: If successful, the driving-simulator test could give clinicians and traffic medicine teams a more realistic tool to identify drivers at risk from excessive daytime sleepiness and help prevent drowsy-driving crashes.
How similar studies have performed: The standard MWT is an established tool for measuring wakefulness, but the naturalistic driving-simulator approach is relatively new and has limited prior validation compared with the standard test.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Zurich, ZRH
- Division of Traffic Medicine, Institute of Forensic Medicine, University of Zurich — Zurich, Zrh, Switzerland (Recruiting)
Study contacts
- Principal investigator: Stefan Lakämper, Dr. rer. nat. — University of Zurich
- Study coordinator: Stefan Lakämper, Dr. rer. nat.
- Email: stefan.lakaemper@irm.uzh.ch
- Phone: +41793789984
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.