- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05453643
EEG Analysis for the Objective Assessment of Drowsiness (MEEGASAFE)
EEG Analysis for the Objective Assessment of Secondary Hypersomnolence in Order to Limit the Accidental Risk
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jean-Arthur MICOULAUD-FRANCHI, MD/PhD
- Phone Number: 05 57 82 01 73
- Email: jean-arthur.micoulaud-franchi@chu-bordeaux.fr
Study Contact Backup
- Name: jacques Taillard, PhD
- Phone Number: 05 57 82 01 73
- Email: jacques.taillard@u-bordeaux.fr
Study Locations
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-
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Bordeaux, France, 33076
- CHU Bordeaux
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Contact:
- Jean-Arthur Micoulaud-Franchi, MD-Phd
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- BMI between 18 and 27,
- With a score on the PHQ-4 scale less than or equal to 2 for scores A (Anxiety) and D (Depression),
- Subjects with no complaints of excessive daytime sleepiness (total ESS score <11),
- Non-professional drivers,
- Subjects who have held their driving license for at least one year,
- Subjects affiliated to a social security scheme,
- Subjects able to understand the study,
- Subjects available to come to the 3 visits required by the study,
- Free, informed and written consent signed
Exclusion Criteria:
- Pathologies that can induce excessive daytime sleepiness: untreated narcolepsy or idiopathic hypersomnia, untreated restless legs syndrome, untreated periodic leg movement syndrome,
- Chronic insomnia disorder,
- Excessive alcohol consumption (> 2 glasses per day) during the last 6 months,
- Excessive consumption of coffee, tea or cola-type caffeinated beverages (> 5 cups/day),
- Severe pathologies involving the vital prognosis in the short term,
- Uncontrolled endocrine pathologies (dysthyroidism, diabetes),
- All progressive cardiac pathologies, treated or untreated,
- All progressive neurological conditions treated or not (brain tumor, epilepsy, migraine, stroke, sclerosis, myoclonus, chorea, neuropathy, muscular dystrophies, myotonic dystrophy, etc.),
- Substance dependence,
- Shift workers or night workers who have performed on-call or on-call duty in the last 72 hours,
- Patients taking psychotropic drugs (antidepressants, antihistamines),
- Long-term treatment with benzodiazepines and z-drugs,
- Patients on cardiotropic,
- Deprived of liberty by a judicial or administrative decision,
- Pregnant or breastfeeding woman,
- Subject under legal protection (guardianship, wardship) or deprived from his rights following administrative or judicial decision
Study Plan
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Sleep deprivation
healthy volunteers
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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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Objective Sleepiness Scale (OSS) during extended wakefulness
Time Frame: Once every 4 hours during SDP1 and SDP2 wakefulness
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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 |
Once every 4 hours during SDP1 and SDP2 wakefulness
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Karolinska sleepiness scale (KSS) during extended wakefulness
Time Frame: 12 assessments every 4 hours during SDP1 and SDP2 wakefulness
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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.
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12 assessments every 4 hours during SDP1 and SDP2 wakefulness
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Change in sleep onset mesured by Maintenance of Wakefulness Test (MWT) during extended wakefulness
Time Frame: Once every 4 hours during SDP1 and SDP2 wakefulness
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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).
|
Once every 4 hours during SDP1 and SDP2 wakefulness
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Change in number of inappropriate line crossings (driving performance) during extended wakefulness
Time Frame: Once every 4 hours during SDP1 and SDP2 wakefulness
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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. |
Once every 4 hours during SDP1 and SDP2 wakefulness
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Change in Standard deviation of the lateral position of the car (driving performance) during extended wakefulness
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. |
Once every 4 hours during SDP1 and SDP2 wakefulness
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Change Sustained and selective attention during extended wakefulness
Time Frame: Once every 4 hours during SDP1 and SDP2 wakefulness
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The reaction time of subject to the presentation of a "target" stimulus (Continuous Performance Test, CPT)
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Once every 4 hours during SDP1 and SDP2 wakefulness
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Change in Vigilance during extended wakefulness
Time Frame: Once every 4 hours during SDP1 and SDP2 wakefulness
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The test examines the ability to concentrate and maintain attention over a long period (30mn) (TAP vigilance test)
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Once every 4 hours during SDP1 and SDP2 wakefulness
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Change in Simple reaction time test (PVT) during extended wakefulness
Time Frame: 1 time every 4 hours during SDP1 and SDP2 wakefulness
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Reaction-timed task that measures the consistency with which subjects respond to a visual stimulus.
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1 time every 4 hours during SDP1 and SDP2 wakefulness
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Change in conscious experience during extended wakefulness
Time Frame: 5 assessments every 4 hours during SDP1 and SDP2 wakefulness
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Questionnaire suggests participant's attention and thoughts were entirely focused on task-related stimuli
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5 assessments every 4 hours during SDP1 and SDP2 wakefulness
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Munich Chorotype Questionnaire
Time Frame: Once time during inclusion. Visit V0
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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).
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Once time during inclusion. Visit V0
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Horne and Ostberg morning/evening questionnaire (MEQ)
Time Frame: Once time during inclusion. Visit V0
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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. |
Once time during inclusion. Visit V0
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Daydreaming frequency scale
Time Frame: Once time during inclusion. Visit V0
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To assess participants' general tendency to daydream in daily life
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Once time during inclusion. Visit V0
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Total sleep time (PSG)
Time Frame: 2 times before SDP1 and SDP2
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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.
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2 times before SDP1 and SDP2
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Sleep onset latency (PSG)
Time Frame: 2 times before SDP1 and SDP2
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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.
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2 times before SDP1 and SDP2
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Sleep efficiency (PSG)
Time Frame: 2 times before SDP1 and SDP2
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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.
|
2 times before SDP1 and SDP2
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Amount of sleep stages (PSG)
Time Frame: 2 times before SDP1 and SDP2
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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.
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2 times before SDP1 and SDP2
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Wake after sleep onset (PSG)
Time Frame: 2 times before SDP1 and SDP2
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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.
|
2 times before SDP1 and SDP2
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Total sleep time (actigraphy)
Time Frame: 2 times before SDP1 and SDP2
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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)
|
2 times before SDP1 and SDP2
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Sleep onset latency (actigraphy)
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)
|
2 times before SDP1 and SDP2
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Sleep efficiency (actigraphy)
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)
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2 times before SDP1 and SDP2
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Wake after sleep onset (actigraphy)
Time Frame: 2 times before SDP1 and SDP2
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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)
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2 times before SDP1 and SDP2
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jean-Arthur Micoulaud-Franchi, MD/PhD, CHU Bordeaux
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MGSF
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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