Driving-simulator sleepiness test compared with the standard wakefulness test for people with OSA after pausing CPAP
Official title: 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
Run by University of Zurich · NCT06872593 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 54 (estimated) |
| Sponsor | University of Zurich Academic / other |
| Locations | 1 site (Zurich, ZRH) |
| Status | Recruiting |
| Started | July 14, 2025 |
| Main results expected | April 30, 2027 |
| Study ends | April 30, 2027 |
| Registry record updated | July 17, 2025 |
| Trial ID | NCT06872593 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Sleep apnea biomarkers and CPAP use after diagnosis
This study tests whether biomarkers from a diagnostic sleep study can predict how well adults with newly diagnosed obstructive sleep apnea will stick to CPAP therapy after about 3 months.
-
F&P Mask usability in home PAP/NIV care for adults with chronic breathing conditions
This study tests how well the F&P Licorice Mask works at home for adults who already use PAP or NIV therapy.
-
Using the PLATO Questionnaire in Oral Appliance Therapy for Obstructive Sleep Apnea
This real-world study tests whether the PLATO questionnaire can be feasibly used in dental sleep clinics for patients receiving oral appliance therapy for obstructive sleep apnea.
-
Managing COMISA: adding daridorexant to CPAP may help sleep and CPAP use
This study tests whether adding daridorexant to CPAP helps people with COMISA better stick with CPAP and feel better.
-
OSA Screening in Diverse Populations
This study tests how common obstructive sleep apnea is across community members and people with certain diseases in China, using screening questionnaires and polysomnography or portable sleep monitors.
-
Wall Squat Exercise to Help Lower Blood Pressure in Adults with Hypertension and Sleep Apnea
This study tests whether doing an isometric wall squat can lower blood pressure in adults who have high blood pressure and sleep apnea treated with CPAP.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.