Sleep Deprivation Study

NCT05560620 | Completed

• 1 other identifier: NCI_NCClin_006
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Change; Sleep Deprivation; Caffeine

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (5)

• 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

• Safety Measures

  2 days

• Demographics

  1 day

• Medical History

  1 day

Study Arms (4)

Sleep Deprivation and Caffeine Intervention

EXPERIMENTAL

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; Other: Caffeine

Sleep Deprivation and no Caffeine intervention

SHAM COMPARATOR

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; Other: No Caffeine

Control and Caffeine

ACTIVE COMPARATOR

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

Control and No Caffeine

SHAM COMPARATOR

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

Interventions

Sleep Deprivation BEHAVIORAL

Participants will be randomized into either the sleep deprivation group or the control group, who will sleep regularly.

Sleep Deprivation and Caffeine Intervention; Sleep Deprivation and no Caffeine intervention

Caffeine OTHER

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.

Control and Caffeine; Sleep Deprivation and Caffeine Intervention

No Caffeine OTHER

De-caffeinated coffee

Control and No Caffeine; Sleep Deprivation and no Caffeine intervention

Eligibility Criteria

• Age: 19 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Any sex, between the ages of 19 and 45.
• 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.
• Willing to consume caffeine in coffee form
• 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.)

You may not qualify if:

• 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.)
• Recent (in the last 6 months) history of alcohol or substance misuse.
• Travel across time zones in the last 2 weeks.
• Late night or evening shift work in the last 2 weeks.
• Vaccination for COVID-19 within the last 72 hours prior to baseline.
• 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.)

Sponsors & Collaborators

• NeuroCatch Inc.: lead

Study Sites (1)

HealthTech Connex Centre for Neurology Studies

Surrey, British Columbia, V3V 0C6, Canada

Location

MeSH Terms

Conditions

Sleep Deprivation

Interventions

Caffeine

Condition Hierarchy (Ancestors)

Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Xanthines; Alkaloids; Heterocyclic Compounds; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 2-group, randomized design

Study Record Dates

• First Submitted: June 7, 2022
• First Posted: September 29, 2022
• Study Start: June 3, 2022
• Primary Completion: July 26, 2022
• Study Completion: August 1, 2022
• Last Updated: September 29, 2022

Record last verified: 2022-09

Locations

CA (1)