Part A• To assess the effect of sleep deprivation on next morning driving (both on road and in simulated driving) and subjective self-reported driving performance tests;• To assess the effect of sleep deprivation on CNS functioning using the…
ID
Source
Brief title
Condition
- Sleep disturbances (incl subtypes)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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) (°C)
• Electrical Burst: PDT (mA), Pain Tolerance Threshold (PTT) (mA), Area Under
the VAS pain Curve (AUC) (mA*mm), and post-test VAS (mm).
• Electrical Stair (pre-cold pressor): PDT (mA), PTT (mA), Area Under the VAS
pain Curve (AUC) (mA*mm), and post-test VAS (mm).
• Electrical Stair (post-cold pressor): PDT (mA), PTT (mA), AUC (mA*mm), and
post-test VAS (mm).
• Conditioned Pain Modulation Response (change from electrical stair pre- and
post-cold pressor): PDT (mA), PTT (mA), AUC (mA*mm).
• Pressure Pain: PDT (kPa), PTT (kPa), AUC (kPa*mm), and post-test VAS (mm).
• Cold Pressor: PDT (s), PTT (s), Area Above the VAS pain Curve (AAC) (s*mm),
and post-test VAS (mm).
• Laser-evoked potentials: Subjective pain perception after LS (LS-NRS):
Numeric rating scale (0-10 with 0=no pain & 10=worst pain imaginable)
• McGill Pain Questionnaire for each individual test
Intra-epidermal electrical stimulation
• Characteristics of the psychophysical curve: nociceptive detection threshold
and slope (A50 & β)
• Intra-epidermal electrical stimulation evoked potentials (IESEP)
Secondary outcome
N.A.
Background summary
The assessment of potential sedative effects of new drugs is an important part
of the early clinical drug development process. Undesired sedative drug effects
may have important consequences, such as an increased risk of traffic
accidents. Various methods are used to quantify sedative drug effects. This
study assesses the sensitivity of additional measures of sedation, including
driving behaviour and brain responses to various sensory and cognitive tasks.
The Centre for Human Drug Research (CHDR) aims to further validate these
methods by demonstrating that they can detect the effects of sleep deprivation.
Additionally, sleep deprivation also affects the perception of pain (e.g.,
lower pain thresholds). In this study the effects of sleep deprivation on a
battery of pain tests will also be determined.
Study objective
Part A
• To assess the effect of sleep deprivation on next morning driving (both on
road and in simulated driving) and subjective self-reported driving performance
tests;
• To assess the effect of sleep deprivation on CNS functioning using the
NeuroCart, a CNS test battery;
• To establish the relationship between on-the-road driving, simulated driving,
and NeuroCart performance;
• To estimate the repeatability of standard deviation of the lateral position
(SDLP) (both on road and in simulated driving) at day time at two different
time points after a regular night of sleep.
Part B
• To assess the effect of sleep deprivation on event related potentials and EEG
• To assess the effect of sleep deprivation on pain tolerance / pain detection
threshold using the PainCart, a pain test battery;
• To investigate the effect of sleep deprivation on IES sensitivity and LEPs;
• To estimate the repeatability of IES and LEP at day time at two different
time points after a regular night of sleep.
Part C
• To assess the effect of sleep deprivation on pain tolerance / pain detection
threshold using the PainCart, a pain test battery;
• To investigate the effect of sleep deprivation on IES sensitivity and LEPs;
• To estimate the repeatability of IES and LEP at day time at two different
time points after a regular night of sleep.
Study design
An exploratory single-centre cross-over study in healthy subjects.
Intervention
Sleep deprivation
Study burden and risks
There is no benefit for the subjects in this study. The risk of the
intervention is negligible. For the on-the-road test are safety precautions
taken: a driving instructor has access to dual controls to intervene when
needed for safety reasons and the subject is instructed about the possibility
to stop the driving test before the planned ending.
Zernikedreef 8
Leiden 2333CL
NL
Zernikedreef 8
Leiden 2333CL
NL
Listed location countries
Age
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
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL68626.056.19 |