CHU bordeaux
Bordeaux, 33076, France
NCT Number: NCT05453643
The objective of this clinical study is to develop solutions for the evaluation and management of drowsiness, based on 2 EEG sensors only, aiming at reducing the risk of accidents related to secondary hypersomnolence (sleepiness induced by sleep restriction or abnormal sleep/wake cycle). This project will allow a better understanding of the determinants of drowsiness and its impact on cognitive performance and the development of methods and models for the evaluation and prediction of cognitive performance deficit related to sleepiness. The secondary hypersomnolence will be objectified by continuous EEG recording and analysed by visual reading according to Objective Sleepiness Scale (OSS) criteria and automatically analyzed using the MEEGAWAKE algorithm (developed by PHYSIP). The level of secondary hypersomnolence will be modified by varying the duration and maintening of prior sleep or the sleep timing. The ability to stay awake will be measured by the maintenance of wakefulness test (MWT). Subjective sleepiness and mind wandering will be measured before and/or after all measurements. Simulated driving task, maintenance of wakefulness tests and several cognitive tasks to measure sustained attention, alertness, selective attention will be performed every 4 hours.
This study is active but is not currently recruiting participants.
Notify Me20 year–60 year
All sexes
Interventional
Not applicable
Bordeaux, 33076, France
Chronotype and general tendency to daydream in daily life will be evaluated at the inclusion visit. Healthy volunteers will be placed in sleep deprivation patterns that will modify the level of secondary hypersomnolence. These patterns correspond to sleep deprivation caused by work schedules usually observed: shift work (SDP1) or night on-call (SDP2). shift work will be simulated by total sleep deprivation for 24 hours (comparable to the first day of a night worker) followed by early morning sleep, and an extended 17 hours wakefulness (comparable to second day of night shift). Secondary hypersomnolence will be assessed throughout prolonged awakenings (24 hours + 17 hours). The night on-call will be simulated by two half-hour awakenings during the nocturnal sleep. Hypersomnolence will be measured within 17 hours of wakefulness following this sleep fragmentation. The sleep history (quantity and quality of sleep) will be evaluated by actigraphy + ambulatory polysomnography (1 day before the experiment) and 2 polysomnographies in the laboratory during the experiment. Polysomnography recordings will be visually and automatically analyzed by the ASEEGA algorithm. Ambulatory recordings are automatically analyzed by ASEEGA. Throughout these sleep deprivation patterns, electrophysiological variables (EEG, EOG and EMG) will be continuously recorded in order to identify objective drowsiness states determined visually using the OSS or automatically by the MEEGAWAKE algorithm. Subjective sleepiness scale, Mind wandering scale, maintenance of wakefulness tests (MWT, electrophysiological test) and cognitive tests will be repeated, every 4hr, throughout the sleep deprivation patterns in order to determine abilities to stay awake, driving performance, sustained and selective attention, vigilance.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Sleep deprivation patterns 1 (SDP1) ; total sleep deprivation for 24 hours followed by early morning sleep and an extended 17 hours wakefulness. Sleep deprivation patterns 2 (SDP2) : Sleep interrupted by two half-hour awakenings
Time frame: Once every 4 hours during SDP1 and SDP2 wakefulness
OSS is based on the visual analysis of electrophysiological variables (EEG (C4, O2, C3, P3), 1 vertical EOG and 1 horizontal EOG).
Each state of drowsiness (score) corresponds to a specific EEG activity accompanied by well-differentiated blinking and eye movements
Time frame: 12 assessments every 4 hours during SDP1 and SDP2 wakefulness
The KSS is a self-administered questionnaire that measures, on a 10 point Likert scale ranging from=1 to "fully awake" to 10 ="extremely drowsy". This measure has very good external validity on EEG synchronization measures and on the cognitive and behavioral performance of subject in relation to his or her ability to maintain wakefulness.
Time frame: Once every 4 hours during SDP1 and SDP2 wakefulness
This is test ability to stay awake in laboratory conditions conductive to falling asleep. The sleep onset latency is obtained during an electrophysiological test (EEG, EMG and EOG).
Time frame: Once every 4 hours during SDP1 and SDP2 wakefulness
On the driving simulator the subjects will drive on a highway scenario representing a reconstruction of the real highway. Number of inappropriate line crossings (ILC) will mesured.
An ILC was recorded when the car crossed a right or left lateral lane marker, whatever the duration and the amplitude of the crossing. Exceptions were overtaking manoeuvres or some other necessary driving action.
Time frame: Once every 4 hours during SDP1 and SDP2 wakefulness
On the driving simulator the subjects will drive on a highway scenario representing a reconstruction of the real highway. Standard deviation of the lateral position of the car (SDLP in cm) will mesured.
Lateral Position was defined as being 0 when the car was in the center of the lane, with positive value to the right and negative values to the left.
Time frame: Once every 4 hours during SDP1 and SDP2 wakefulness
The reaction time of subject to the presentation of a "target" stimulus (Continuous Performance Test, CPT)
Time frame: Once every 4 hours during SDP1 and SDP2 wakefulness
The test examines the ability to concentrate and maintain attention over a long period (30mn) (TAP vigilance test)
Time frame: 1 time every 4 hours during SDP1 and SDP2 wakefulness
Reaction-timed task that measures the consistency with which subjects respond to a visual stimulus.
Time frame: 5 assessments every 4 hours during SDP1 and SDP2 wakefulness
Questionnaire suggests participant's attention and thoughts were entirely focused on task-related stimuli
Time frame: Once time during inclusion. Visit V0
The Munich Chorotype Questionnaire (MCTQ) quantifies the chronotype according to the phase of entrainment based on the reported the mid-time of sleep; The MCTQ parameters are mid-sleep on weekdays (MSW in hr), mid-sleep on free days (MSF in hr) and mid-sleep on free days corrected for sleep debt on weekdays (MSFsc in hr). The MSFsc score (used as a chronotype indicator) represents a continuum of circadian preference, with an increasing tendency toward the evening type. MCTQ parameters are represented by hours, ranging from 0 hour (extreme morningness) to 12 hours (extreme eveningness).
Time frame: Once time during inclusion. Visit V0
The Horne and Ostberg morning/evening questionnaire (MEQ) quantifies the chronotype.
The MEQ contains19 questions on life preferences (activity, sleep-wake cycle, meals) and the state of fatigue and drowsiness at certain times of the day. The MEQ score ranges from 16-86, with evening type ranging from16-41, neither or intermediate type from 42-58, and morning type from 59-86.
Time frame: Once time during inclusion. Visit V0
To assess participants' general tendency to daydream in daily life
Time frame: 2 times before SDP1 and SDP2
Total sleep time, the number of minutes asleep in bed after "lights off", will be calculated using a polysomnographic recording (PSG). EEG, EOG and EMG will be recorded during sleep.
Time frame: 2 times before SDP1 and SDP2
Sleep onset latency, the minutes from lights off to sleep onset, will be calculated using a polysomnographic recording (PSG). EEG, EOG and EMG will be recorded during sleep.
Time frame: 2 times before SDP1 and SDP2
Sleep efficiency, the ratio of the total time spent asleep (total sleep time) in a night compared to the total amount of time spent in bed, will be calculated using a polysomnographic recording (PSG). EEG, EOG and EMG will be recorded during sleep.
Time frame: 2 times before SDP1 and SDP2
Amount of N1,N2,N3 and R stage (expressed in p% of TST) will be calculated using a polysomnographic recording (PSG). EEG, EOG and EMG will be recorded during sleep.
Time frame: 2 times before SDP1 and SDP2
Wake after sleep onset, number of minutes scored as wake from sleep onset to the last minute scored as sleep while in bed, will be calculated using a polysomnographic recording (PSG). EEG, EOG and EMG will be recorded during sleep.
Time frame: 2 times before SDP1 and SDP2
Total sleep time, the number of minutes asleep in bed after "lights off", will be calculated using an actigraph (wearable sleep test that tracks wrist movements)
Time frame: 2 times before SDP1 and SDP2
Sleep onset latency, the minutes from lights off to sleep onset, will be calculated using an actigraph (wearable sleep test that tracks wrist movements)
Time frame: 2 times before SDP1 and SDP2
Sleep efficiency, the ratio of the total time spent asleep (total sleep time) in a night compared to the total amount of time spent in bed will be calculated using an actigraph (wearable sleep test that tracks wrist movements)
Time frame: 2 times before SDP1 and SDP2
Wake after sleep onset, number of minutes scored as wake from sleep onset to the last minute scored as sleep while in bed will be calculated using an actigraph (wearable sleep test that tracks wrist movements)
This study is active but is not currently recruiting participants.
Notify MePhysip S.A
Industry
EEG Analysis for the Objective Assessment of Secondary Hypersomnolence in Order to Limit the Accidental Risk
Acronym: MEEGASAFE
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