Validating a Novel Driving Simulation-based MWT Against the Standard MWT in an OSA-cohort Challenged by CPAP-withdrawal

NCT06872593 | Recruiting

• 1 other identifier: DS-MWT2
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

In brief, the proposed study will evaluate a recently proposed naturalistic, driving simulation test to identify and measure sleepiness behind the wheel, one of the most underestimated causes of road accidents. The proposed test offers higher ecological validity and might complement somnological tests that are standard, but rarely performed. Thus, the test might provide traffic medicine and sonologists with an effective tool, that can also directly convey the risks of excessive daytime sleepiness to drivers and thus, in combination, effectively aid in traffic medicine's mandate to avoid preventable road fatalities. Excessive daytime sleepiness (EDS) is a symptomatic condition resulting from too little or compromised sleep, caused by psycho-social stress (shiftwork, lifestyle) or medical conditions (obstructive sleep apnoea (OSA), narcolepsy). Driving with untreated EDS might lead to sleepy/drowsy driving and microsleep, which is considered to be one of the highest-ranking causes of road accidents. Sleepiness and its dangers on the wheel might subjectively not be registered by the affected drivers. Also, subjective sleepiness might not correlate with somnological measurements that are also crucial for legally determining the fitness to drive (FTD). There exists a variety of partially complementary tools to evaluate the extent of EDS. Mean sleep latency obtained in the maintenance of wakefulness test (MWT) is widely, but not uniformly, considered to be one of the most objective measures to evaluate EDS, especially in the context of driving performance. However, there is inconsistent or insufficient evidence for MWTs to reliably predict the FTD in general, potentially as its result might be strongly influenced by motivation. Moreover, patients might not relate low mean MWT-latencies to their own and other's risks in traffic. A need for improved tools to measure EDS was formulated. It remains open, whether the MWT should be replaced or complemented by, for example, future road-side metabolomics-tests detecting sleepiness in traffic or whether the MWT should be adapted to better convey a.) the risks of EDS in traffic and b.) its meaning for the determination of the FTD. With this need in mind the investigators proposed furnishing the maintenance of wakefulness test with improved ecological validity to provide an improved tool for the assessment of the effect of excessive daytime sleepiness on the fitness to drive: recently published results from an exploratory feasibility study suggested it to be well possible to transfer the MWT-paradigm to a driving simulator (DS) with high user acceptance. The published result's implication and relevance was well received: the new test, DS-MWT, might complement somnological MWTs in pneumology and neurology. I might provide a naturalistic and relatable tool to determine EDS in traffic medicine, who is institutionally responsible for determining the FTD. This is also desirable, because prohibitively high cost - in time, money and instrumentation - often prevent a standard MWT in standard care of sleep-related medical conditions. Potentially, the use of the DS-MWT might help reduce the number of preventable road fatalities by more often identifying sleepy individuals before they get behind the wheel. However, for this goal to be achieve, it remains to be evaluated whether the latencies obtained in classical or simulation conditions are comparable and whether obtained latencies actually reflect other clinical parameters of EDS relating to underlying medical conditions, such as for example OSA. This represents a significant gap of evidence for both medical experts in pneumology and traffic medicine, but also for affected drivers. This gap will be filled by systematically comparing classical and simulation-based MWTs by means of their resulting latencies. In a within-study setup of 36 highly adherent OSA-patients, experiments will be related to a main medical comparator, a ≥7-day continuous positive airway pressure (CPAP)-withdrawal (W) and subsequent -resumption or continuation (C), respectively. There will be a control group of 18 healthy participants for comparison.

Conditions

Excessive Daytime Sleepiness; Obstructive Sleep Apnea (OSA); CPAP Treatment; Driving Simulator Performance; Driving Impaired; CPAP

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

Outcome Measures

Primary Outcomes (1)

• significant difference between mean MWT- and DS-MWT-latencies

  significant difference between mean latencies measured in classical maintenance of wakefulness test (MWT, M) and driving simulation-based maintenance of wakefulness test (DS-MWT, D) and DS-MWT-latencies.

  MWT- and DS-MWT-latencies are measured in two consecutive days during CPAP-treatment and after 7 days CPAP-withdrawal (intervention) in randomized order.

Study Arms (6)

OSA - W(first) + MD

EXPERIMENTAL

allocated OSA-participants will perform test sequence M -\> D first after 7d CPAP-withdrawal, then after ≥7d CPAP.

Procedure: CPAP-withdrawal; Diagnostic Test: Test Sequence

OSA - W(first) + DM

EXPERIMENTAL

allocated OSA-participants will perform test sequence D -\> M first after 7d CPAP-withdrawal, then after ≥7d CPAP.

Procedure: CPAP-withdrawal; Diagnostic Test: Test Sequence

OSA - C(first) + MD

EXPERIMENTAL

allocated OSA-participants will perform test sequence M -\> D first after ≥7d CPAP, then after 7d CPAP-withdrawal.

Procedure: CPAP-withdrawal; Diagnostic Test: Test Sequence

OSA - C(first) + DM

EXPERIMENTAL

allocated OSA-participants will perform test sequence D-\> M first after ≥7d CPAP, then after 7d CPAP-withdrawal.

Procedure: CPAP-withdrawal; Diagnostic Test: Test Sequence

Healthy control MD - DM

OTHER

healthy participants will perform test sequence M -\> D first , then D -\> M

Diagnostic Test: Test Sequence

Healthy control DM - MD

OTHER

healthy participants will perform test sequence D -\> M first , then M -\> D.

Diagnostic Test: Test Sequence

Interventions

CPAP-withdrawal PROCEDURE

7-day-long CPAP-withdrawal

OSA - C(first) + DM; OSA - C(first) + MD; OSA - W(first) + DM; OSA - W(first) + MD

Test Sequence DIAGNOSTIC_TEST

Test Sequence M or D as specified in arm description

Healthy control DM - MD; Healthy control MD - DM; OSA - C(first) + DM; OSA - C(first) + MD; OSA - W(first) + DM; OSA - W(first) + MD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Stefan Lakämper: lead
• University Hospital, Zürich: collaborator

Study Sites (1)

Division of Traffic Medicine, Institute of Forensic Medicine, University of Zurich

Zurich, ZRH, 8050, Switzerland

RECRUITING

Related Publications (1)

• Pisteljic M, Keller K, Lakamper S. Capturing sleep accidents in driving simulation as a promising tool to assess excessive daytime sleepiness with high ecological validity-a pilot study. Sleep. 2024 Aug 14;47(8):zsae110. doi: 10.1093/sleep/zsae110. No abstract available.

  PMID: 38758109 BACKGROUND

Related Links

• Swiss National Clinical Trial Prortall (SNCTP) Registration of DS-MWT2

MeSH Terms

Conditions

Disorders of Excessive Somnolence; Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Stefan Lakämper, Dr. rer. nat.

  University of Zurich

  PRINCIPAL INVESTIGATOR

• Esther I Schwarz, PD, Dr. med.

  University of Zurich

  PRINCIPAL INVESTIGATOR

• Kristina Keller, Dr. med.

  University of Zurich

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefan Lakämper, Dr. rer. nat.

CONTACT

+41793789984; stefan.lakaemper@irm.uzh.ch

Veronika Gambin, MSc

CONTACT

+41797149386; veronika.gambin@irm.uzh.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr. rer. nat. , Head Research & Research Development, Division of TRaffic Medicine, Institute for Forensic Medicine, University of Zurich

Model Details: monocentric, controlled, randomized, crossover trial, with two groups and four arms, plus a two-armed crossover control group

Study Record Dates

• First Submitted: March 6, 2025
• First Posted: March 12, 2025
• Study Start: July 14, 2025
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: July 17, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: starting after publication of study protcol and/or results
• Access Criteria: upon request by mail

Locations

CH (1)