Sleep DeprivationMEEGASAFENCT05453643
EEG Analysis for the Objective Assessment of Drowsiness
A study testing sleep deprivation patterns in people with Sleep Deprivation, run by Physip S.A at 1 site in France.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Deprivation
- What is being tested?
- sleep deprivation patterns
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 8 Mar 2023to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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,
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- Subjects able to understand the study,
- Subjects available to come to the 3 visits required by the study,
- Free, informed and written consent signed
Who cannot join
- 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),
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EEG Analysis for the Objective Assessment of Secondary Hypersomnolence in Order to Limit the Accidental Risk
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.
Read the detailed description
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.
- Conditions
- Sleep Deprivation
- Being tested
- sleep deprivation patterns
- Keywords
- Sleep deprivation, Secondary hypersomnolence, Objective Sleepiness, Subjective Sleepiness, Cognitive performance, Driving
- Medical subject headings
- Sleep Deprivation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sleep deprivation patternsBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Sleep deprivation | Experimental | healthy volunteers Receives: Behavioral: sleep deprivation patterns |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Objective Sleepiness Scale (OSS) during extended 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
Measured: Once every 4 hours during SDP1 and SDP2 wakefulness
Secondary outcomes (20)
Change in Karolinska sleepiness scale (KSS) during extended 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.
Measured: 12 assessments every 4 hours during SDP1 and SDP2 wakefulness
Change in sleep onset mesured by Maintenance of Wakefulness Test (MWT) during extended 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).
Measured: Once every 4 hours during SDP1 and SDP2 wakefulness
Change in number of inappropriate line crossings (driving performance) during extended 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.
Measured: Once every 4 hours during SDP1 and SDP2 wakefulness
Change in Standard deviation of the lateral position of the car (driving performance) during extended 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.
Measured: Once every 4 hours during SDP1 and SDP2 wakefulness
Change Sustained and selective attention during extended wakefulness
The reaction time of subject to the presentation of a "target" stimulus (Continuous Performance Test, CPT)
Measured: Once every 4 hours during SDP1 and SDP2 wakefulness
Change in Vigilance during extended wakefulness
The test examines the ability to concentrate and maintain attention over a long period (30mn) (TAP vigilance test)
Measured: Once every 4 hours during SDP1 and SDP2 wakefulness
Change in Simple reaction time test (PVT) during extended wakefulness
Reaction-timed task that measures the consistency with which subjects respond to a visual stimulus.
Measured: 1 time every 4 hours during SDP1 and SDP2 wakefulness
Change in conscious experience during extended wakefulness
Questionnaire suggests participant's attention and thoughts were entirely focused on task-related stimuli
Measured: 5 assessments every 4 hours during SDP1 and SDP2 wakefulness
Munich Chorotype Questionnaire
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).
Measured: Once time during inclusion. Visit V0
Horne and Ostberg morning/evening questionnaire (MEQ)
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.
Measured: Once time during inclusion. Visit V0
Daydreaming frequency scale
To assess participants' general tendency to daydream in daily life
Measured: Once time during inclusion. Visit V0
Total sleep time (PSG)
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.
Measured: 2 times before SDP1 and SDP2
Sleep onset latency (PSG)
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.
Measured: 2 times before SDP1 and SDP2
Sleep efficiency (PSG)
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.
Measured: 2 times before SDP1 and SDP2
Amount of sleep stages (PSG)
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.
Measured: 2 times before SDP1 and SDP2
Wake after sleep onset (PSG)
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.
Measured: 2 times before SDP1 and SDP2
Total sleep time (actigraphy)
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)
Measured: 2 times before SDP1 and SDP2
Sleep onset latency (actigraphy)
Sleep onset latency, the minutes from lights off to sleep onset, will be calculated using an actigraph (wearable sleep test that tracks wrist movements)
Measured: 2 times before SDP1 and SDP2
Sleep efficiency (actigraphy)
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)
Measured: 2 times before SDP1 and SDP2
Wake after sleep onset (actigraphy)
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)
Measured: 2 times before SDP1 and SDP2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2022
- Study start8 Mar 2023
- Primary completion23 May 2025
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep DeprivationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Physip S.A
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Bordeaux, National Research Agency, France
- Responsible party
- Sponsor
- Investigators
- Jean-Arthur Micoulaud-Franchi, MD/PhD, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05453643
- Sponsor's protocol ID
- MGSF
- Acronym
- MEEGASAFE
- Status last verified
- Sep 2026
- First submitted
- 14 Jun 2022
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Boitard C, Mazurie Z, Sadatnejad K, Coelho J, Sagaspe P, Lenoir J, Mattei J, Berthomier P, Brandewinder M, Philip P, Micoulaud Franchi JA, Berthomier C, Taillard J. Evaluating Electroencephalogram-Based Predictive Model for Drowsiness Measurement to Reduce Accident Risk in Active Individuals: Protocol for a Preliminary Monocentric Study. JMIR Res Protoc. 2026 Feb 17;15:e83969. doi: 10.2196/83969.
PubMed 41701939
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EEG Analysis for the Objective Assessment of Secondary Hypersomnolence in Order to Limit the Accidental Risk
- ClinicalTrials.gov ID
- NCT05453643
- Acronym / sponsor ID
- MEEGASAFE / MGSF
- Conditions
- Sleep Deprivation
- Keywords
- Sleep deprivation, Secondary hypersomnolence, Objective Sleepiness, Subjective Sleepiness, Cognitive performance, Driving
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Physip S.AIndustry (pharma, biotech, devices)
- Collaborators
- University of Bordeaux, National Research Agency, France
- Study start
- 8 Mar 2023 (actual)
- Primary completion
- 23 May 2025 (actual)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 12 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sleep deprivation | Experimental | Behavioral: sleep deprivation patternshealthy volunteers |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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,
Key exclusion criteria (16 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sleep deprivation patternsSleep 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 | Behavioural | Sleep deprivation |
Primary outcome
Change in Objective Sleepiness Scale (OSS) during extended wakefulness
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
20 secondary outcomes
Change in Karolinska sleepiness scale (KSS) during extended wakefulness
Time frame: 12 assessments every 4 hours during SDP1 and SDP2 wakefulness
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
Change in number of inappropriate line crossings (driving performance) during extended wakefulness
Time frame: Once every 4 hours during SDP1 and SDP2 wakefulness
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
Change Sustained and selective attention during extended wakefulness
Time frame: Once every 4 hours during SDP1 and SDP2 wakefulness
Change in Vigilance during extended wakefulness
Time frame: Once every 4 hours during SDP1 and SDP2 wakefulness
Change in Simple reaction time test (PVT) during extended wakefulness
Time frame: 1 time every 4 hours during SDP1 and SDP2 wakefulness
Change in conscious experience during extended wakefulness
Time frame: 5 assessments every 4 hours during SDP1 and SDP2 wakefulness
Munich Chorotype Questionnaire
Time frame: Once time during inclusion. Visit V0
Horne and Ostberg morning/evening questionnaire (MEQ)
Time frame: Once time during inclusion. Visit V0
Daydreaming frequency scale
Time frame: Once time during inclusion. Visit V0
Total sleep time (PSG)
Time frame: 2 times before SDP1 and SDP2
Sleep onset latency (PSG)
Time frame: 2 times before SDP1 and SDP2
Sleep efficiency (PSG)
Time frame: 2 times before SDP1 and SDP2
Amount of sleep stages (PSG)
Time frame: 2 times before SDP1 and SDP2
Wake after sleep onset (PSG)
Time frame: 2 times before SDP1 and SDP2
Total sleep time (actigraphy)
Time frame: 2 times before SDP1 and SDP2
Sleep onset latency (actigraphy)
Time frame: 2 times before SDP1 and SDP2
Sleep efficiency (actigraphy)
Time frame: 2 times before SDP1 and SDP2
Wake after sleep onset (actigraphy)
Time frame: 2 times before SDP1 and SDP2
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Derived from this study: PubMed 41701939Boitard C, Mazurie Z, Sadatnejad K, Coelho J, Sagaspe P, Lenoir J, Mattei J, Berthomier P, Brandewinder M, Philip P, Micoulaud Franchi JA, Berthomier C, Taillard J. Evaluating Electroencephalogram-Based Predictive Model for Drowsiness Measurement to Reduce Accident Risk in Active Individuals: Protocol for a Preliminary Monocentric Study. JMIR Res Protoc. 2026 Feb 17;15:e83969. doi: 10.2196/83969.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Arthur Micoulaud-Franchi, MD/PhD principal investigator
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sleep deprivation patterns in people with Sleep Deprivation, run by Physip S.A at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Objective Sleepiness Scale (OSS) during extended wakefulness (time frame: Once every 4 hours during SDP1 and SDP2 wakefulness). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05453643, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.