Brain Oxygenation Marker for Cognitive Function in Healthy Adults

NCT05559034 | Completed

• 1 other identifier: 2205NR
• Study Type: observational
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Mental Fatigue

Keywords

Cortical tissue oxygenation; Cognition; Time-on-task; Functional Near Infrared Spectroscopy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Healthy adults

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

Behavioral: Cognitive intervention

Interventions

Cognitive intervention 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.

Healthy adults

Eligibility Criteria

• Age: 25 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

The study population will comprise of 36 healthy adults from 25 to 45 years old.

You may qualify if:

• 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)
• Be dominant right-handed
• Have a normal or corrected-to-normal vision
• Be expected to comply with the protocol

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead
• Ecole Polytechnique Fédérale de Lausanne: collaborator

Study Sites (1)

Clinical Innovation Lab

Lausanne, Canton of Vaud, 1000, Switzerland

Location

MeSH Terms

Conditions

Mental Fatigue

Condition Hierarchy (Ancestors)

Fatigue; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Study Officials

• Sélima Zahar, Master

  Société des Produits Nestlé and Ecole Polytechnique Fédérale de Lausanne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Target Duration: 3 Weeks
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2022
• First Posted: September 29, 2022
• Study Start: September 6, 2022
• Primary Completion: December 15, 2022
• Study Completion: December 15, 2022
• Last Updated: March 24, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The data will only be available from the preliminary to the last analysis performed (i.e. end of the study).
• Access Criteria: A thesis agreement to cover the data protection has been agreed with the laboratory of the doctoral thesis director. The access to the data will be performed via secure directories of Société des Produits Nestlé.

Locations

CH (1)