Capturing sleep accidents in driving simulation as a promising tool to assess excessive daytime sleepiness with high ecological validity-a pilot study.
Melissa Pisteljic, Kristina Keller, Stefan Lakämper
https://pubmed.ncbi.nlm.nih.gov/38758109Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID06872593
Validating a Novel Driving Simulation-based Maintenance of Wakefulness Test Against the Standard MWT in an OSA Cohort Challenged by CPAP Withdrawal A Monocentric, Controlled, Randomized, Crossover Trial
Led by Stefan Lakämper · Updated on 2025-07-17
54
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
S
Stefan Lakämper
Lead Sponsor
U
University Hospital, Zürich
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a new driving simulation test designed to measure excessive daytime sleepiness (EDS) behind the wheel, a major cause of road accidents. This study focuses on patients with obstructive sleep apnea (OSA) who use continuous positive airway pressure (CPAP) treatment. The goal is to compare this novel simulation-based maintenance of wakefulness test (DS-MWT) with the standard MWT to see if the simulation test better reflects real-world sleepiness and driving risks, potentially improving fitness-to-drive assessments. Participants include adults diagnosed with OSA who are highly compliant with CPAP treatment, as well as healthy control drivers. The study involves CPAP withdrawal for 7 days followed by resumption or continuation, with participants undergoing sequences of standard and simulation-based tests in randomized order. Healthy participants also perform both test sequences for comparison. This trial is randomized, controlled, and crossover in design. During the study, participants will complete both classical and simulation-based MWTs on consecutive days under different CPAP conditions. Researchers will measure and compare mean latencies from both tests to assess sleepiness levels. Assessments include eye tracking that requires contact lenses for those with impaired eyesight. The study aims to provide a more naturalistic tool for evaluating sleepiness and driving fitness, with safety and adherence closely monitored throughout the trial.
CONDITIONS
Brief Title
Validating a Novel Driving Simulation-based MWT Against the Standard MWT in an OSA-cohort Challenged by CPAP-withdrawal
Who Can Participate
Age: 18Years +
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Adult drivers diagnosed with obstructive sleep apnea (OSA) on established CPAP treatment
- Highly adherent and compliant with CPAP therapy (>5 hours per night, >80% of days in last 6 months)
- Impaired eyesight requiring more than ±5 diopters or astigmatism and use of contact lenses (for eye tracking)
- Healthy adult drivers without psychiatric or sleep-related diagnoses (for control group)
- Ability to understand study procedures
You will not qualify if you...
- Sensitivity to motion sickness, dizziness, or similar symptoms during a 5-minute screening drive
- Professional drivers working during the study period
- Inability to understand the study procedures due to language or cognitive reasons
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
CPAP Withdrawal
Duration - 7 days
Participants with obstructive sleep apnea stop CPAP treatment for 7 days to assess the impact on wakefulness.
Daily visits or assessments during withdrawal period
Test Sequence
Duration - 2 consecutive days per test sequence
Participants complete diagnostic tests including the Maintenance of Wakefulness Test (MWT) and a novel driving simulation-based MWT on two consecutive days in randomized order during CPAP-withdrawal and during CPAP treatment.
2 visits (in-person) per test sequence
CPAP Treatment
Duration - At least 7 days
Participants resume or continue CPAP treatment for at least 7 days between test sequences to compare wakefulness measures.
Daily visits or assessments during CPAP treatment period
Trial Site Locations
Total: 1 location
1
Division of Traffic Medicine, Institute of Forensic Medicine, University of Zurich
Zurich, ZRH, Switzerland, 8050
Actively Recruiting
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Research Team
S
Stefan Lakämper, Dr. rer. nat.
V
Veronika Gambin, MSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
PREVENTION
Number of Arms
6
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