Clinical trial NCT05559034: Brain Oxygenation Marker for Cognitive Function in Healthy Adults
Official title: Identification of a Brain Oxygenation Marker for Cognition Using Functional Near Infrared Spectroscopy in Healthy Adults
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mental Fatigue
Keywords: Cortical tissue oxygenation
Cognition
Time-on-task
Functional Near Infrared Spectroscopy
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
Collaborators: name: Ecole Polytechnique Fédérale de Lausanne
First posted: 2022-09-29
Enrollment: 37
Sex: ALL
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will comprise of 36 healthy adults from 25 to 45 years old.

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

1. Males and Females 25-45 years old
2. BMI between 18.5 kg/m2 and 29.9 kg/m2
3. 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)
   * Be dominant right-handed
   * Have a normal or corrected-to-normal vision
   * Be expected to comply with the protocol

Exclusion Criteria:

The project exclusion criteria are:

1. 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)
   * 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
2. 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
3. Have a hierarchal or family relationship with any of the research team members.
4. Currently participating in another interventional study.

Primary outcomes:
measure: Modulation of cortical tissue oxygenation
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Clinical Innovation Lab
state: Vaud
Study officials:
affiliation: Société des Produits Nestlé and Ecole Polytechnique Fédérale de Lausanne
name: Sélima Zahar, Master
role: PRINCIPAL_INVESTIGATOR
References: