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/38758109/Actively Recruiting
Led by Stefan Lakämper · Updated on 2025-07-17
54
Participants Needed
1
Research Sites
N/A
Total Duration
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
Validating a Novel Driving Simulation-based MWT Against the Standard MWT in an OSA-cohort Challenged by CPAP-withdrawal
S
Stefan Lakämper, Dr. rer. nat.
V
Veronika Gambin, MSc
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Stefan Lakämper
Lead Sponsor
University Hospital, Zürich
Collaborating Sponsor
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
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
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
PREVENTION
Number of Arms
6
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Melissa Pisteljic, Kristina Keller, Stefan Lakämper
https://pubmed.ncbi.nlm.nih.gov/38758109/Veronika Gambin, Nan Li, Esther Irene Schwarz...
https://pubmed.ncbi.nlm.nih.gov/42424269/Stefan Lakämper
Lead Sponsor
University Hospital, Zürich
Collaborating Sponsor