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Search / Trial NCT06872593

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

Sleep Drowsy Driving Sleepy Driving Sleepiness Behind The Wheel Driving Simulation Cpap Treatment Cpap Withdrawal Driving Performance Sleep Latency Maintenance Of Wakefulness Test Mwt Microsleep Microsleep Like Episodes Eye Tracking Eeg Recording

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.

Locations

Zurich, Zrh, Switzerland

Patients applied

0 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