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Sleep Deprivation Study

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ClinicalTrials.gov Identifier: NCT05560620
Recruitment Status : Completed
First Posted : September 29, 2022
Last Update Posted : September 29, 2022
Sponsor:
Information provided by (Responsible Party):
NeuroCatch Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cognitive Change Sleep Deprivation Caffeine Behavioral: Sleep Deprivation Other: Caffeine Other: No Caffeine Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 2-group, randomized design
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Impact of Sleep Deprivation on Objective, Physiological Measures of Brain Function Cognition
Actual Study Start Date : June 3, 2022
Actual Primary Completion Date : July 26, 2022
Actual Study Completion Date : August 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caffeine

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Change in NeuroCatch® Platform 2 (NCP2), event-related potentials (ERPs) Amplitudes [ Time Frame: 2 days ]
    N100, P300 and N400 amplitude values

  2. Change in NeuroCatch® Platform 2 (NCP2), event-related potentials (ERPs) Latencies [ Time Frame: 2 days ]
    N100, P300 and N400 latency values

  3. 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

  4. 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 Outcome Measures :
  1. Change in NeuroCatch® Platform 2 (NCP2), event-related potentials (ERPs) pre and post caffeine intervention [ Time Frame: 1 day ]
    N100, P300 and N400 amplitude and latency values

  2. 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) [ Time Frame: 1 day ]
    Cogstate accuracy (% of correct responses) and reaction time (ms) scores

  3. Safety Measures [ Time Frame: 2 days ]
    Frequency, severity and type of AEs, ADEs, and DDs

  4. Demographics [ Time Frame: 1 day ]
  5. Medical History [ Time Frame: 1 day ]

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   19 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05560620


Locations
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Canada, British Columbia
HealthTech Connex Centre for Neurology Studies
Surrey, British Columbia, Canada, V3V 0C6
Sponsors and Collaborators
NeuroCatch Inc.
More Information
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Responsible Party: NeuroCatch Inc.
ClinicalTrials.gov Identifier: NCT05560620    
Other Study ID Numbers: NCI_NCClin_006
First Posted: September 29, 2022    Key Record Dates
Last Update Posted: September 29, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sleep Deprivation
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Neurologic Manifestations
Mental Disorders
Caffeine
Central Nervous System Stimulants
 Physiological Effects of Drugs
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents