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Twilight: Brain Oxygenation Marker for Cognitive Function in Healthy Adults

Sponsor
Nestlé (Industry)
Overall Status
Completed
CT.gov ID
NCT05559034
Collaborator
Ecole Polytechnique Fédérale de Lausanne (Other)
37
Enrollment
1
Location
3.3
Actual Duration (Months)
11.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Cognitive intervention

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 Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
37 participants
Observational Model:
Other
Time Perspective:
Other
Official Title:
Identification of a Brain Oxygenation Marker for Cognition Using Functional Near Infrared Spectroscopy in Healthy Adults
Actual Study Start Date :
Sep 6, 2022
Actual Primary Completion Date :
Dec 15, 2022
Actual Study Completion Date :
Dec 15, 2022

Arms and Interventions

Arm Intervention/Treatment
Healthy adults

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

Outcome Measures

Primary Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
25 Years to 45 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

  1. 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

  1. Have a hierarchal or family relationship with any of the research team members.

  2. Currently participating in another interventional study.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Clinical Innovation Lab Lausanne Vaud Switzerland 1000

Sponsors and Collaborators

  • Nestlé
  • Ecole Polytechnique Fédérale de Lausanne

Investigators

  • Principal Investigator: Sélima Zahar, Master, Société des Produits Nestlé and Ecole Polytechnique Fédérale de Lausanne

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Nestlé
ClinicalTrials.gov Identifier:
NCT05559034
Other Study ID Numbers:
  • 2205NR
First Posted:
Sep 29, 2022
Last Update Posted:
Jan 19, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Nestlé
Cortical tissue oxygenation
Cognition
Time-on-task
Functional Near Infrared Spectroscopy
Additional relevant MeSH terms:
Mental Fatigue

Study Results

No Results Posted as of Jan 19, 2023