Brain Oxygenation Marker for Cognitive Function in Healthy Adults

Mental Fatigue Clinical Trial

Official title:

Identification of a Brain Oxygenation Marker for Cognition Using Functional Near Infrared Spectroscopy in Healthy Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05559034
• Other study ID #: 2205NR
• Status: Completed
• Start date: September 6, 2022
• Est. completion date: December 15, 2022

Study information

• Verified date: March 2023
• Source: Société des Produits Nestlé (SPN)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: December 15, 2022
• Est. primary completion date: December 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Mental Fatigue

Intervention

Behavioral:
• Cognitive intervention
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.

Locations

Country	Name	City	State
Switzerland	Clinical Innovation Lab	Lausanne	Vaud

Sponsors (2)

Lead Sponsor	Collaborator
Société des Produits Nestlé (SPN)	Ecole Polytechnique Fédérale de Lausanne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 1