FATIGUEMOTIVATESNCT05531734
MONITORING OF ATTENTION ACCORDING TO FATIGUE IN THE HEALTHY SUBJECT
A study testing NaoX Intra-Auricular Device (IAD) monitoring EEG data and Simple psychometric tests in people with FATIGUE and Sleep Deprivation, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
To develop an easy-to-use measurement tool for monitoring fatigue and alertness, particularly in sleep-deprived subjects. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- FATIGUE, Sleep Deprivation
- What is being tested?
- NaoX Intra-Auricular Device (IAD) monitoring EEG data and Simple psychometric tests
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 22 Mar 2023to Sep 2025
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers.
- Male, female.
- Medical residents.
- Aged between 24 and 34 years.
- Doing emergency, intensive care or "inside" shifts.
- Working in a health institution.
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- No history of epilepsy.
- No background treatment that could have an impact on the EEG (electroencephalogram) data (type: benzodiazepines, anti-epileptics).
- No significant change in background treatment during the study, if any.
- Affiliation to the social security system.
- Informed volunteer who has signed a consent form.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Pediatric Intensive Care Unit, Raymond Poincaré Hospital, APHP
Garches, 92380
About this study
To develop an easy-to-use measurement tool for monitoring fatigue and alertness, particularly in sleep-deprived subjects.
Read the detailed description
Objective and primary endpoint:
Demonstrate that the NaoX measurement tool detects sleep deprivation in medical residents performing medical shifts.
The primary endpoint is the detection of a significant decrease in Coefficient Alpha Attenuation (CAA) between the pre- and post-sleep deprivation measurements.
The data analysis will be blinded to the measurement.
Secondary endpoints and objectives :
Demonstrate a link between the Alpha Attenuation Coefficient (AAC) measured by the NaoX measurement tool and the vigilance tests.
Endpoint: significant increase in PVT (Psychomotor Vigilance Task) time associated with a significant decrease in Alpha Attenuation Coefficient (AAC).
Demonstrate a link between the Alpha Attenuation Coefficient (AAC) measured by the NaoX measurement tool and the state of fatigue experienced.
Endpoint: significant increase in Karolinska Sleepiness Scale (KSS) score associated with a significant decrease in Alpha Attenuation Coefficient (AAC).
Experimental scheme:
3 cycles of 2 recordings with the NaoX measurement tool associated with a self-questionnaire and vigilance tests (approximately 30 minutes per recording), carried out before and after a night shift by a medical resident.
Population targeted:
Medical residents performing night shifts of at least 12 hours.
- Conditions
- FATIGUE, Sleep Deprivation
- Being tested
- NaoX Intra-Auricular Device (IAD) monitoring EEG data, Simple psychometric tests
- Keywords
- Measurement tool, EEG data, sleep deprivation, attention, electroencephalogram
- Medical subject headings
- Fatigue, Sleep Deprivation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NaoX Intra-Auricular Device (IAD) monitoring EEG dataDevice
Intrauaricular measurement tool developed by NaoX Technology to retrieve EEG type data.
Simple psychometric testsBehavioural
Associated with simple and self-managed psychometric tests.
| Study group | Role | What they receive |
|---|---|---|
| volunteers | Experimental | Health volunteers Receives: Device: NaoX Intra-Auricular Device (IAD) monitoring EEG data; Behavioral: Simple psychometric tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
EEG data collected by head phone like EEG electrodes developed by NaoX Technologies
Demonstrate that the NaoX head phone like EEG electrodes detects sleep deprivation in medical residents performing medical shifts.
The primary endpoint is the detection of a significant decrease in Coefficient Alpha Attenuation (CAA) between the pre- and post-sleep deprivation measurements.
The data analysis will be blinded to the measurement.
Measured: through study completion, an average of 12 hours
Secondary outcomes (2)
Demonstrate a link between the Alpha Attenuation Coefficient (AAC) measured by NaoX head phone like EEG electrodes and the vigilance tests
Endpoint: significant increase in PVT (Psychomotor Vigilance Task) time associated with a significant decrease in Alpha Attenuation Coefficient (AAC).
Measured: through study completion, an average of 12 hours
Demonstrate a link between the Alpha Attenuation Coefficient (AAC) measured by the NaoX head phone like EEG electrodes tool and the state of fatigue experienced
Endpoint: significant increase in Karolinska Sleepiness Scale (KSS) score associated with a significant decrease in Alpha Attenuation Coefficient (AAC).
Measured: through study completion, an average of 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2022
- Study start22 Mar 2023
- Primary completionSep 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FATIGUEStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean BERGOUNIOUX, MD, PhD, Principal investigator, Pediatric Intensive Care Unit, Raymond Poincaré Hospital, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05531734
- Sponsor's protocol ID
- APHP220576
- Other IDs
- 2022-A01959-34
- Acronym
- MOTIVATES
- Status last verified
- Apr 2025
- First submitted
- 14 Jun 2022
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MONITORING OF ATTENTION ACCORDING TO FATIGUE IN THE HEALTHY SUBJECT
- ClinicalTrials.gov ID
- NCT05531734
- Acronym / sponsor ID
- MOTIVATES / APHP220576
- Conditions
- FATIGUE, Sleep Deprivation
- Keywords
- Measurement tool, EEG data, sleep deprivation, attention, electroencephalogram
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 22 Mar 2023 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 8 Sep 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.
To develop an easy-to-use measurement tool for monitoring fatigue and alertness, particularly in sleep-deprived subjects.
Detailed description
Objective and primary endpoint:
Demonstrate that the NaoX measurement tool detects sleep deprivation in medical residents performing medical shifts.
The primary endpoint is the detection of a significant decrease in Coefficient Alpha Attenuation (CAA) between the pre- and post-sleep deprivation measurements.
The data analysis will be blinded to the measurement.
Secondary endpoints and objectives :
Demonstrate a link between the Alpha Attenuation Coefficient (AAC) measured by the NaoX measurement tool and the vigilance tests.
Endpoint: significant increase in PVT (Psychomotor Vigilance Task) time associated with a significant decrease in Alpha Attenuation Coefficient (AAC).
Demonstrate a link between the Alpha Attenuation Coefficient (AAC) measured by the NaoX measurement tool and the state of fatigue experienced.
Endpoint: significant increase in Karolinska Sleepiness Scale (KSS) score associated with a significant decrease in Alpha Attenuation Coefficient (AAC).
Experimental scheme:
3 cycles of 2 recordings with the NaoX measurement tool associated with a self-questionnaire and vigilance tests (approximately 30 minutes per recording), carried out before and after a night shift by a medical resident.
Population targeted:
Medical residents performing night shifts of at least 12 hours.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| volunteers | Experimental | Device: NaoX Intra-Auricular Device (IAD) monitoring EEG data, Behavioral: Simple psychometric testsHealth volunteers |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Healthy volunteers.
- Male, female.
- Medical residents.
- Aged between 24 and 34 years.
- Doing emergency, intensive care or "inside" shifts.
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| NaoX Intra-Auricular Device (IAD) monitoring EEG dataIntrauaricular measurement tool developed by NaoX Technology to retrieve EEG type data. | Device | volunteers |
| Simple psychometric testsAssociated with simple and self-managed psychometric tests. | Behavioural | volunteers |
Primary outcome
EEG data collected by head phone like EEG electrodes developed by NaoX Technologies
Time frame: through study completion, an average of 12 hours
Demonstrate that the NaoX head phone like EEG electrodes detects sleep deprivation in medical residents performing medical shifts. The primary endpoint is the detection of a significant decrease in Coefficient Alpha Attenuation (CAA) between the pre- and post-sleep deprivation measurements. The data analysis will be blinded to the measurement.
2 secondary outcomes
Demonstrate a link between the Alpha Attenuation Coefficient (AAC) measured by NaoX head phone like EEG electrodes and the vigilance tests
Time frame: through study completion, an average of 12 hours
Demonstrate a link between the Alpha Attenuation Coefficient (AAC) measured by the NaoX head phone like EEG electrodes tool and the state of fatigue experienced
Time frame: through study completion, an average of 12 hours
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 27 Apr 2025.
- 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.
Jean BERGOUNIOUX, MD, PhD principal investigator
Pediatric Intensive Care Unit, Raymond Poincaré Hospital, APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NaoX Intra-Auricular Device (IAD) monitoring EEG data and Simple psychometric tests in people with FATIGUE and Sleep Deprivation, run by Assistance Publique - Hôpitaux de Paris 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 11 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 27 Apr 2025. 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?
Contact Jean BERGOUNIOUX, MD, PhD (+ 33 (0)1 47 10 79 00 ext. 41131, jean.bergounioux@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EEG data collected by head phone like EEG electrodes developed by NaoX Technologies (time frame: through study completion, an average of 12 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Apr 2025.