Brain Oxygenation Marker for Cognitive Function in Healthy Adults

Completed

• Conditions: Mental Fatigue
• Interventions: Behavioral: Cognitive intervention

• Registration Number: NCT05559034
• Lead Sponsor: Société des Produits Nestlé (SPN)

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.

Study Timeline

• Study Start: 2022-09-06
• Study First Submitted: 2022-09-12
• Study First Submitted QC: 2022-09-26
• Study First Posted: 2022-09-29
• Primary Completion: 2022-12-15
• Study Completion: 2022-12-15
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-22
• Last Update Posted: 2023-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy adults	Cognitive intervention	The study will comprise only one group of healthy adults subject to a same behavioral and cognitive intervention.

Primary Outcome Measures

Name	Time	Method
Modulation of cortical tissue oxygenation	Day 1	Cortical tissue oxygenation parameters will be given by the concentration changes of oxygenated and deoxygenated hemoglobins measured with functional Near Infrared Spectroscopy.

Trial Locations

Locations (1)

Clinical Innovation Lab; 🇨🇭 Lausanne, Vaud, Switzerland