Mental FatigueNCT05559034
Brain Oxygenation Marker for Cognitive Function in Healthy Adults
An observational study of Mental Fatigue, run by Société des Produits Nestlé (SPN) at 1 site in Switzerland.
Trial summary
This study aims to identify a cortical oxygenation marker for cognitive function using functional Near Infrared Spectroscopy in healthy adults. Read more about this study
- Who is it for?
- Ages 25 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Fatigue
- What is being tested?
- Cognitive intervention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 37 participants
- Where
- 1 siteSwitzerland
- Study dates
- 6 Sep 2022to 15 Dec 2022
- How long will I take part?
- 3 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
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 25 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The study population will comprise of 36 healthy adults from 25 to 45 years old.
Who may be able to join
- Males and Females 25-45 years old
- BMI between 18.5 kg/m2 and 29.9 kg/m2
- Conditions for study procedure compliance:
- Willing and able to sign an informed consent form
- Be fluent in English (self-reported C1 or C2 English level)
- Be able to provide a cortical oxygenation signal (based on feasibility to fix the measurement device on the scalp, which can be altered by hair thickness)
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- Be dominant right-handed
- Have a normal or corrected-to-normal vision
- Be expected to comply with the protocol
Who cannot join
- The project exclusion criteria are:
- Conditions that may affect cortical oxygenation:
- Be insomniac (insomnia severity index, ISI, higher than 15 based on rating at the medical screening) or night shift worker (based on anamnesis)
- Be currently diagnosed with migraine (based on anamnesis)
- Be currently diagnosed with hypo- or hyper-tension (based on evaluation of BP measure against medical norms at the medical screening)
- Have an historical or current neural, cerebrovascular, cardiovascular, or respiratory disease (based on anamnesis)
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- Have a heavy usual consumption of caffeine-based beverages i.e., more than 5 servings of caffeinated coffee/colas or tea or 1 serving of caffeinated energy drinks per day
- Be a regular smoker (regularly defined as greater than 2 cigarettes per week)
- Participate in a vigorous physical activity requiring more than 6 metabolic equivalents e.g., hiking, jogging at 10 km/h or more, carrying of heavy loads, bicycling fast at 23 km/h or more, basketball, soccer, and tennis single, greater than 4 times 45 minutes per week
- Conditions that may affect cognition or the mental fatigue
- Take illicit drugs (for e.g., cannabis, heroin, and cocaine)
- Have an average alcohol consumption greater than 2 standard drinks per day over a week for males, and greater than 1 standard drink per day over a week for females.
- One standard drink contains 10-12 g of ethanol. Examples of standard drinks are one beer can (300 ml), one glass of wine (100 ml) or one glass of schnaps (30 ml).
- Have a psychiatric disorder or be currently diagnosed with anxiety or depression
- Be pregnant (verified by a pregnancy test in urine dipstick format) or seeking to become pregnant or breast feeding
- Have a hierarchal or family relationship with any of the research team members.
- Currently participating in another interventional study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Identification of a Brain Oxygenation Marker for Cognition Using Functional Near Infrared Spectroscopy in Healthy Adults
This study aims to identify a cortical oxygenation marker for cognitive function using functional Near Infrared Spectroscopy in healthy adults.
Read the detailed description
This study will aim to establish a model between the cortical oxygenation and cognitive performances given modulations by experimental conditions including the cognitive workload and the time-on-task, and individual variabilities such as the age or the gender.
- Conditions
- Mental Fatigue
- Being tested
- Cognitive intervention
- Keywords
- Cortical tissue oxygenation, Cognition, Time-on-task, Functional Near Infrared Spectroscopy
- Medical subject headings
- Mental Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive interventionBehavioural
This is a cognitive intervention consisting in the repetition according to three blocks, of cognitive tasks (Stroop and N-back tasks) at variating workload levels (low, middle and high levels). Each cognitive task will be presented for each workload level during three minutes.
| Study group | Role | What they receive |
|---|---|---|
| Healthy adults | The study will comprise only one group of healthy adults subject to a same behavioral and cognitive intervention. Receives: Behavioral: Cognitive intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modulation of cortical tissue oxygenation
Cortical tissue oxygenation parameters will be given by the concentration changes of oxygenated and deoxygenated hemoglobins measured with functional Near Infrared Spectroscopy.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2022
- Study start6 Sep 2022
- Primary completion15 Dec 2022
- Study completion15 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental FatigueStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 37 participants (actual)
- Target duration
- 3 Weeks
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ecole Polytechnique Fédérale de Lausanne
- Responsible party
- Sponsor
- Investigators
- Sélima Zahar, Master, Principal investigator, Société des Produits Nestlé and Ecole Polytechnique Fédérale de Lausanne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05559034
- Sponsor's protocol ID
- 2205NR
- Status last verified
- Mar 2023
- First submitted
- 12 Sep 2022
- Last updated
- 24 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Access to the data will only be given to the academic laboratory hosting the aforementioned doctoral study. This concerns the Medical Image Processing laboratory, Ecole Polytechnique Fédérale de Lausanne.
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of a Brain Oxygenation Marker for Cognition Using Functional Near Infrared Spectroscopy in Healthy Adults
- ClinicalTrials.gov ID
- NCT05559034
- Acronym / sponsor ID
- 2205NR
- Conditions
- Mental Fatigue
- Keywords
- Cortical tissue oxygenation, Cognition, Time-on-task, Functional Near Infrared Spectroscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Collaborators
- Ecole Polytechnique Fédérale de Lausanne
- Study start
- 6 Sep 2022 (actual)
- Primary completion
- 15 Dec 2022 (actual)
- Study completion
- 15 Dec 2022 (actual)
- First posted
- 29 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.
This study aims to identify a cortical oxygenation marker for cognitive function using functional Near Infrared Spectroscopy in healthy adults.
Detailed description
This study will aim to establish a model between the cortical oxygenation and cognitive performances given modulations by experimental conditions including the cognitive workload and the time-on-task, and individual variabilities such as the age or the gender.
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 3 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy adults | – | Behavioral: Cognitive interventionThe study will comprise only one group of healthy adults subject to a same behavioral and cognitive intervention. |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study population will comprise of 36 healthy adults from 25 to 45 years old.
Key inclusion criteria (9 listed)
- Males and Females 25-45 years old
- BMI between 18.5 kg/m2 and 29.9 kg/m2
- Conditions for study procedure compliance:
Key exclusion criteria (17 listed)
- Conditions that may affect cortical oxygenation:
- Conditions that may affect cognition or the mental fatigue
- One standard drink contains 10-12 g of ethanol. Examples of standard drinks are one beer can (300 ml), one glass of wine (100 ml) or one glass of schnaps (30 ml).
- Have a hierarchal or family relationship with any of the research team members.
- Currently participating in another interventional study.
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 |
|---|---|---|
| Cognitive interventionThis is a cognitive intervention consisting in the repetition according to three blocks, of cognitive tasks (Stroop and N-back tasks) at variating workload levels (low, middle and high levels). Each cognitive task will be presented for each workload level during three minutes. | Behavioural | Healthy adults |
Primary outcome
Modulation of cortical tissue oxygenation
Time frame: Day 1
Cortical tissue oxygenation parameters will be given by the concentration changes of oxygenated and deoxygenated hemoglobins measured with functional Near Infrared Spectroscopy.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2023.
- Individual participant dataSharing planned: Yes. Access to the data will only be given to the academic laboratory hosting the aforementioned doctoral study. This concerns the Medical Image Processing laboratory, Ecole Polytechnique Fédérale de Lausanne.
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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.
Sélima Zahar, Master principal investigator
Société des Produits Nestlé and Ecole Polytechnique Fédérale de Lausanne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mental Fatigue, run by Société des Produits Nestlé (SPN) at 1 site in Switzerland.
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 17 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: finished, as of the sponsor's last update on 24 Mar 2023. 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 Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Modulation of cortical tissue oxygenation (time frame: Day 1). 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 24 Mar 2023; AzTrials last refreshed its copy on 30 Oct 2026.