Validating a Novel Driving Simulation-based MWT Against the Standard MWT in an OSA-cohort Challenged by CPAP-withdrawal
Launched by STEFAN LAKÄMPER · Mar 6, 2025
Trial Information
Current as of April 29, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial aims to test a new driving simulation test that measures how sleepy a person might feel while driving. This is important because feeling excessively sleepy can lead to dangerous driving situations, which is a major cause of road accidents. The study will compare this new test, called the Driving Simulation-Maintenance of Wakefulness Test (DS-MWT), with the standard test currently used to assess sleepiness, known as the Maintenance of Wakefulness Test (MWT). The goal is to see if the driving simulation provides better insights into a person’s ability to drive safely, particularly for those with a condition called obstructive sleep apnea (OSA) who are using a CPAP machine to help them sleep better.
To take part in this study, participants must be adult drivers diagnosed with OSA and have been using their CPAP machine regularly. There will also be a group of healthy participants without sleep disorders for comparison. Throughout the study, participants will undergo both the standard test and the driving simulation, giving important information about how sleepiness affects driving ability. This research could help identify sleepy drivers more effectively and potentially reduce the number of accidents caused by drowsy driving.
Gender
ALL
Eligibility 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.
About Stefan Lakämper
Stefan Lakämper is a dedicated clinical trial sponsor renowned for advancing innovative research in the biomedical field. With a focus on enhancing patient outcomes, Lakämper oversees a diverse portfolio of clinical studies, emphasizing rigorous scientific methodology and ethical standards. By fostering collaboration among researchers, healthcare professionals, and regulatory bodies, he aims to drive the development of groundbreaking therapies and medical interventions. Committed to transparency and excellence, Lakämper prioritizes the safety and well-being of participants throughout the clinical trial process.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Zurich, Zrh, Switzerland
Patients applied
Trial Officials
Stefan Lakämper, Dr. rer. nat.
Principal Investigator
University of Zurich
Esther I Schwarz, PD, Dr. med.
Principal Investigator
University of Zurich
Kristina Keller, Dr. med.
Principal Investigator
University of Zurich
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported