An exploratory single-centre cross-over study in healthy subjects to investigate the effects of sleep deprivation on driving, EEG, and PainCart.

An exploratory single-centre cross-over study in healthy subjects to investigate the effects of sleep deprivation on driving, EEG, and PainCart. - Effects of sleep deprivation on driving, cognition, EEG, and PainCart.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON48420

Enrollment

Registered

2019-02-01

Start date

2019-02-07

Completion date

Unknown

Last updated

2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

insomnia sleep deprivation

Interventions

Sleep deprivation

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Male (part A and B) or female (part C only) Age between 23 and 35 At least 3 years in possession of a drivers license (only part A). At least 3000 km/y driving experience over the last 3 years. (only part A).

Exclusion criteria

Exclusion criteria: Presence of psychiatric illness Drug abuse in medical history Sleep disorder Pain disorder (including chronic) Only for part B and C: dark skin type (Fitzpatrick V-VI)

Design outcomes

Primary

Measure	Time frame
Safety and tolerability endpoints Part A, B and C The safety is judged by investigator assessment. Pharmacodynamic endpoints Part A Simulated and on the road driving • Standard deviation of lateral position (SDLP) (main parameter) • Number of lane departures (e.g., crash risk) • Mean speed (MS) • Standard deviation of speed (SDS) • Perceived driving quality scale and perceived effort scale • Driving quality scale by driving instructor • Car driving exploratory biomarkers (drive safety score, head movements, steering wheel) Questionnaires • Leeds Sleep Evaluation Questionnaire (LSEQ) • Karolinska sleepiness scale (KSS) NeuroCart Adaptive tracking • Average performance on adaptive tracking CFB (%) Body Sway • Total antero-posterior sway (mm) Eye movements • percentage time the subjects eyes are in smooth pursuit of the target during smooth pursuit VAS Bond and Lader • Composite scores for alertness (mm) Part B NeuroCart Adaptive tracking • Average performance on adaptive tracking CFB (%) Body Sway • Total antero-posterior sway (mm) Eye movements • percentage time the subjects eyes are in smooth pursuit of the target during smooth pursuit VAS Bond and Lader • Composite scores for alertness (mm) Resting-EEG • Frequency band power (Hz) EEG in combination with auditory steady-state response • The average inter-trial phase coherence between 35 and 45 Hz and between 200 and 500 ms • The average evoked power between 35 and 45 Hz and between 200 and 500 ms EEG in combination with Oddball tasks • P300 and MMN amplitudes (µV) and latencies (msec) EEG in combination with visual evoked potentials (VEP) • N75 and P100 amplitudes (µV) and latencies (msec) Part B and C: Questionnaires • Leeds Sleep Evaluation Questionnaire (LSEQ) • Karolinska sleepiness scale (KSS EEG in combination with laser-evoked potentials (LEP) • Amplitude (µV ) and latency (ms) of LEPs (N2, P2, and N2P2) PainCart • Heat Pain: Pain Detection Threshold (PDT	—

Measure

Time frame

Safety and tolerability endpoints Part A, B and C The safety is judged by investigator assessment. Pharmacodynamic endpoints Part A Simulated and on the road driving • Standard deviation of lateral position (SDLP) (main parameter) • Number of lane departures (e.g., crash risk) • Mean speed (MS) • Standard deviation of speed (SDS) • Perceived driving quality scale and perceived effort scale • Driving quality scale by driving instructor • Car driving exploratory biomarkers (drive safety score, head movements, steering wheel) Questionnaires • Leeds Sleep Evaluation Questionnaire (LSEQ) • Karolinska sleepiness scale (KSS) NeuroCart Adaptive tracking • Average performance on adaptive tracking CFB (%) Body Sway • Total antero-posterior sway (mm) Eye movements • percentage time the subjects eyes are in smooth pursuit of the target during smooth pursuit VAS Bond and Lader • Composite scores for alertness (mm) Part B NeuroCart Adaptive tracking • Average performance on adaptive tracking CFB (%) Body Sway • Total antero-posterior sway (mm) Eye movements • percentage time the subjects eyes are in smooth pursuit of the target during smooth pursuit VAS Bond and Lader • Composite scores for alertness (mm) Resting-EEG • Frequency band power (Hz) EEG in combination with auditory steady-state response • The average inter-trial phase coherence between 35 and 45 Hz and between 200 and 500 ms • The average evoked power between 35 and 45 Hz and between 200 and 500 ms EEG in combination with Oddball tasks • P300 and MMN amplitudes (µV) and latencies (msec) EEG in combination with visual evoked potentials (VEP) • N75 and P100 amplitudes (µV) and latencies (msec) Part B and C: Questionnaires • Leeds Sleep Evaluation Questionnaire (LSEQ) • Karolinska sleepiness scale (KSS EEG in combination with laser-evoked potentials (LEP) • Amplitude (µV ) and latency (ms) of LEPs (N2, P2, and N2P2) PainCart • Heat Pain: Pain Detection Threshold (PDT

—

Secondary

Measure	Time frame
N.A.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)