Sleep Deprivation Study

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

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.

Study Overview

• Status: Completed
• Conditions: Cognitive Change; Sleep Deprivation; Caffeine
• Intervention / Treatment: Behavioral: Sleep Deprivation; Other: Caffeine; Other: No Caffeine

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Surrey, British Columbia, Canada, V3V 0C6
      • HealthTech Connex Centre for Neurology Studies

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Any sex, between the ages of 19 and 45.
2. Able to understand the informed consent form, study procedures and willing to participate in study
3. Able to perform the testing required by the study.
4. Able to remain seated for 10 minutes
5. In good health with no history of clinically relevant neurological illness, acute disease or conditions or injury in the last 5 years.
6. A score of ≤ 5 on the Pittsburgh Sleep Quality Index (PSQI)
7. A score between 42 and 58 on the Morningness- Eveningness Questionnaire (MEQ)
8. Coffee consumption of < 5 cups per day.
9. Alcohol consumption of <15 units per week.
10. Self-described regular sleep pattern for the last 2 weeks.
11. Willing to consume caffeine in coffee form
12. Follow regular daily routine 24 hours prior to Baseline and between Baseline 1 and Baseline 2 study visits (i.e. sleep time, caffeine consumption etc.)

Exclusion Criteria:

1. Alcohol or CBD or THC consumption 24 hours prior to baseline and during the study
2. Currently and regularly taking sleep medications or supplements or medications that effect sleep
3. Any health condition (e.g. chronic fatigue) that would prevent the subject from completing the required testing.
4. Undergoing chemotherapy or any form of intensive long-term therapy.
5. Recent (3 months) injury or other acute condition that required treatment with pain killers or analgesics.
6. History of chronic pain or chronic headache disorders, including migraines.
7. History of TBI or condition that affects the brain or CNS.
8. Currently diagnosed with major psychiatric disorders (schizophrenia, bipolar, depression, generalized anxiety disorder)
9. Diagnosed with any memory disorders.
10. Currently diagnosed with any sleeping disorders (e.g. sleep apnea, hypersomnia, insomnia, parasomnia etc.)
11. Recent (in the last 6 months) history of alcohol or substance misuse.
12. Travel across time zones in the last 2 weeks.
13. Late night or evening shift work in the last 2 weeks.
14. Vaccination for COVID-19 within the last 72 hours prior to baseline.
15. Currently experiencing Covid-19 symptoms, including: fever or chills, cough, tiredness/fatigue, headache, sore throat, muscle or body aches, new loss of taste or smell, congestion or runny nose, nausea or vomiting, diarrhea, difficulty breathing or shortness of breath, or chest pain.)
16. If female and of child-bearing potential: pregnant, suspected or planning to become pregnant or breast-feeding
17. Contraindications for the NeuroCatch Platform:

17.1. Requires use of hearing aids or a cochlear implant 17.2. Diagnosed with tinnitus that is currently active 17.3. Temporary damage to hearing (e.g. punctured ear drum). 17.4. Implanted pacemaker or implanted electrical stimulators 17.5. Metal or plastic implants in the skull, excluding dental/facial implants. 17.6. Exposed to an investigational drug or device 30 days prior to start in this study, or concurrent or planned use of investigational drug or device while enrolled in this study* 17.7. Not proficient in the English language 17.8. Diagnosed epilepsy or history of seizures 17.9. If female and of child-bearing potential: pregnant, suspected or planning to become pregnant or breast-feeding 17.10. Unhealthy scalp (apparent open wounds and/or bruised or weakened skin) 17.11. Allergy to EEG gel

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sleep Deprivation and Caffeine Intervention; Participants randomized into the sleep deprivation group and then randomized into receiving caffeinated coffee the next morning. Participant is blinded to the caffeine intervention.	Behavioral: Sleep Deprivation; Participants will be randomized into either the sleep deprivation group or the control group, who will sleep regularly.; Other: Caffeine; On Day 2 morning, after the sleep deprivation or sleeping, participants will be randomized into receiving caffeinated or de-caffeinated coffee, which they will be blinded to.
Sham Comparator: Sleep Deprivation and no Caffeine intervention; Participants randomized into the sleep deprivation group and then randomized into receiving de-caffeinated coffee the next morning. Participant is blinded to the caffeine intervention.	Behavioral: Sleep Deprivation; Participants will be randomized into either the sleep deprivation group or the control group, who will sleep regularly.; Other: No Caffeine; De-caffeinated coffee
Active Comparator: Control and Caffeine; Participants randomized into the control group, who will sleep regularly, and then randomized into receiving caffeinated coffee the next morning. Participant is blinded to the caffeine intervention.	Other: Caffeine; On Day 2 morning, after the sleep deprivation or sleeping, participants will be randomized into receiving caffeinated or de-caffeinated coffee, which they will be blinded to.
Sham Comparator: Control and No Caffeine; Participants randomized into the control group, who will sleep regularly, and then randomized into receiving de-caffeinated coffee the next morning. Participant is blinded to the caffeine intervention.	Other: No Caffeine; De-caffeinated coffee

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in NeuroCatch® Platform 2 (NCP2), event-related potentials (ERPs) Amplitudes	N100, P300 and N400 amplitude values	2 days
Change in NeuroCatch® Platform 2 (NCP2), event-related potentials (ERPs) Latencies	N100, P300 and N400 latency values	2 days
Change in Cogstate cognitive assessment Accuracy scores from Baseline, Baseline 2 and Study Visit 3 (post-intervention)	accuracy (% of correct responses) scores	2 days
Change in Cogstate cognitive assessment Reaction time scores from Baseline, Baseline 2 and Study Visit 3 (post-intervention)	reaction time (ms) scores	2 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in NeuroCatch® Platform 2 (NCP2), event-related potentials (ERPs) pre and post caffeine intervention	N100, P300 and N400 amplitude and latency values	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)	Cogstate accuracy (% of correct responses) and reaction time (ms) scores	1 day
Safety Measures	Frequency, severity and type of AEs, ADEs, and DDs	2 days
Demographics		1 day
Medical History		1 day

Collaborators and Investigators

• Sponsor: NeuroCatch Inc.

Study record dates

Study Major Dates

• Study Start (Actual): June 3, 2022
• Primary Completion (Actual): July 26, 2022
• Study Completion (Actual): August 1, 2022

Study Registration Dates

• First Submitted: June 7, 2022
• First Submitted That Met QC Criteria: September 26, 2022
• First Posted (Actual): September 29, 2022

Study Record Updates

• Last Update Posted (Actual): September 29, 2022
• Last Update Submitted That Met QC Criteria: September 26, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Dyssomnias; Sleep Wake Disorders; Neurologic Manifestations; Sleep Deprivation; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Purinergic Antagonists; Purinergic Agents; Phosphodiesterase Inhibitors; Purinergic P1 Receptor Antagonists; Central Nervous System Stimulants; Caffeine
• Other Study ID Numbers: NCI_NCClin_006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No