Brain Oxygenation Marker for Cognitive Function in Healthy Adults

Nestlé

Status: Completed

Conditions: Mental Fatigue

Treatments: Behavioral: Cognitive intervention

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05559034

2205NR

Details and patient eligibility

About

This study aims to identify a cortical oxygenation marker for cognitive function using functional Near Infrared Spectroscopy in healthy adults.

Full 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.

Enrollment: 37 patients

Sex: All

Ages: 25 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

37 participants in 1 patient group

Healthy adults

Description:

The study will comprise only one group of healthy adults subject to a same behavioral and cognitive intervention.

Treatment:

Behavioral: Cognitive intervention