Brain Oxygenation Marker for Cognitive Function in Healthy Adults

NCT ID: NCT05559034

Last Updated: 2023-03-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 37 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-09-06
• Study Completion Date: 2022-12-15

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.

Conditions

Mental Fatigue

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: OTHER

Study Groups

Healthy adults

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

Cognitive intervention

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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

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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ecole Polytechnique Fédérale de Lausanne

OTHER

Sponsor Role: collaborator

Société des Produits Nestlé (SPN)

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sélima Zahar, Master

Role: PRINCIPAL_INVESTIGATOR

Société des Produits Nestlé and Ecole Polytechnique Fédérale de Lausanne

Locations

Clinical Innovation Lab

Lausanne, Canton of Vaud, Switzerland

Countries

Switzerland

Other Identifiers

2205NR

Identifier Type: -

Identifier Source: org_study_id