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Completed

NCT Number: NCT05559034

Brain Oxygenation Marker for Cognitive Function in Healthy Adults

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

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Key information

Age range

25 year–45 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinical Innovation Lab

Lausanne, Canton of Vaud, 1000, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

The project exclusion criteria are:

  • 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.
  • Currently participating in another interventional study.

Treatment and study plan

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.

Primary outcomes

  1. Modulation of cortical tissue oxygenation

    Time frame: Day 1

    Cortical tissue oxygenation parameters will be given by the concentration changes of oxygenated and deoxygenated hemoglobins measured with functional Near Infrared Spectroscopy.

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Collaborators

  • Ecole Polytechnique Fédérale de Lausanne

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Sep 29, 2022
Registry last updated
Mar 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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