Impact of Sleep Deprivation on Objective, Physiological Measures of Brain Function Cognition

NeuroCatch Inc.1 site in 1 country48 target enrollmentJune 3, 2022

ConditionsCognitive Change Sleep Deprivation Caffeine

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Cognitive Change
Sponsor: NeuroCatch Inc.
Enrollment: 48
Locations: 1
Primary Endpoint: Change in Cogstate cognitive assessment Accuracy scores from Baseline, Baseline 2 and Study Visit 3 (post-intervention)
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate the measures of brain function, both neurophysiological (event-related potentials (ERPs) and functional (cognitive assessments), in response to sleep deprivation.

Registry

clinicaltrials.gov

Start Date

June 3, 2022

End Date

August 1, 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

NeuroCatch Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Any sex, between the ages of 19 and
•Able to understand the informed consent form, study procedures and willing to participate in study
•Able to perform the testing required by the study.
•Able to remain seated for 10 minutes
•In good health with no history of clinically relevant neurological illness, acute disease or conditions or injury in the last 5 years.
•A score of ≤ 5 on the Pittsburgh Sleep Quality Index (PSQI)
•A score between 42 and 58 on the Morningness- Eveningness Questionnaire (MEQ)
•Coffee consumption of \< 5 cups per day.
•Alcohol consumption of \<15 units per week.
•Self-described regular sleep pattern for the last 2 weeks.

Exclusion Criteria

•Alcohol or CBD or THC consumption 24 hours prior to baseline and during the study
•Currently and regularly taking sleep medications or supplements or medications that effect sleep
•Any health condition (e.g. chronic fatigue) that would prevent the subject from completing the required testing.
•Undergoing chemotherapy or any form of intensive long-term therapy.
•Recent (3 months) injury or other acute condition that required treatment with pain killers or analgesics.
•History of chronic pain or chronic headache disorders, including migraines.
•History of TBI or condition that affects the brain or CNS.
•Currently diagnosed with major psychiatric disorders (schizophrenia, bipolar, depression, generalized anxiety disorder)
•Diagnosed with any memory disorders.
•Currently diagnosed with any sleeping disorders (e.g. sleep apnea, hypersomnia, insomnia, parasomnia etc.)

Outcomes

Primary Outcomes

Change in Cogstate cognitive assessment Accuracy scores from Baseline, Baseline 2 and Study Visit 3 (post-intervention)

Time Frame: 2 days

accuracy (% of correct responses) scores

Change in NeuroCatch® Platform 2 (NCP2), event-related potentials (ERPs) Amplitudes

Time Frame: 2 days

N100, P300 and N400 amplitude values

Change in NeuroCatch® Platform 2 (NCP2), event-related potentials (ERPs) Latencies

Time Frame: 2 days

N100, P300 and N400 latency values

Change in Cogstate cognitive assessment Reaction time scores from Baseline, Baseline 2 and Study Visit 3 (post-intervention)

Time Frame: 2 days

reaction time (ms) scores

Secondary Outcomes

Demographics(1 day)
Safety Measures(2 days)
Change in NeuroCatch® Platform 2 (NCP2), event-related potentials (ERPs) pre and post caffeine intervention(1 day)
Change in Cogstate cognitive assessment measures (Detection Test, Identification Test, One Card Learning, and One Back Task) from Baseline, Baseline 2 and Study Visit 3 (post-intervention)(1 day)
Medical History(1 day)