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Sleep Deprivation Study

Primary Purpose

Cognitive Change, Sleep Deprivation, Caffeine

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Sleep Deprivation
Caffeine
No Caffeine
Sponsored by
NeuroCatch Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Cognitive Change

Eligibility Criteria

19 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • HealthTech Connex Centre for Neurology Studies

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Sham Comparator

Active Comparator

Sham Comparator

Arm Label

Sleep Deprivation and Caffeine Intervention

Sleep Deprivation and no Caffeine intervention

Control and Caffeine

Control and No Caffeine

Arm Description

Participants randomized into the sleep deprivation group and then randomized into receiving caffeinated coffee the next morning. Participant is blinded to the 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.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in NeuroCatch® Platform 2 (NCP2), event-related potentials (ERPs) pre and post caffeine intervention
N100, P300 and N400 amplitude and latency values
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
Safety Measures
Frequency, severity and type of AEs, ADEs, and DDs
Demographics
Medical History

Full Information

First Posted
June 7, 2022
Last Updated
September 26, 2022
Sponsor
NeuroCatch Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05560620
Brief Title
Sleep Deprivation Study
Official Title
Impact of Sleep Deprivation on Objective, Physiological Measures of Brain Function Cognition
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
June 3, 2022 (Actual)
Primary Completion Date
July 26, 2022 (Actual)
Study Completion Date
August 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NeuroCatch Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Change, Sleep Deprivation, Caffeine

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
2-group, randomized design
Masking
Participant
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sleep Deprivation and Caffeine Intervention
Arm Type
Experimental
Arm Description
Participants randomized into the sleep deprivation group and then randomized into receiving caffeinated coffee the next morning. Participant is blinded to the caffeine intervention.
Arm Title
Sleep Deprivation and no Caffeine intervention
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
Control and Caffeine
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control and No Caffeine
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Sleep Deprivation
Intervention Description
Participants will be randomized into either the sleep deprivation group or the control group, who will sleep regularly.
Intervention Type
Other
Intervention Name(s)
Caffeine
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
No Caffeine
Intervention Description
De-caffeinated coffee
Primary Outcome Measure Information:
Title
Change in NeuroCatch® Platform 2 (NCP2), event-related potentials (ERPs) Amplitudes
Description
N100, P300 and N400 amplitude values
Time Frame
2 days
Title
Change in NeuroCatch® Platform 2 (NCP2), event-related potentials (ERPs) Latencies
Description
N100, P300 and N400 latency values
Time Frame
2 days
Title
Change in Cogstate cognitive assessment Accuracy scores from Baseline, Baseline 2 and Study Visit 3 (post-intervention)
Description
accuracy (% of correct responses) scores
Time Frame
2 days
Title
Change in Cogstate cognitive assessment Reaction time scores from Baseline, Baseline 2 and Study Visit 3 (post-intervention)
Description
reaction time (ms) scores
Time Frame
2 days
Secondary Outcome Measure Information:
Title
Change in NeuroCatch® Platform 2 (NCP2), event-related potentials (ERPs) pre and post caffeine intervention
Description
N100, P300 and N400 amplitude and latency values
Time Frame
1 day
Title
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)
Description
Cogstate accuracy (% of correct responses) and reaction time (ms) scores
Time Frame
1 day
Title
Safety Measures
Description
Frequency, severity and type of AEs, ADEs, and DDs
Time Frame
2 days
Title
Demographics
Time Frame
1 day
Title
Medical History
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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.) 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.) 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.) If female and of child-bearing potential: pregnant, suspected or planning to become pregnant or breast-feeding 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
Facility Information:
Facility Name
HealthTech Connex Centre for Neurology Studies
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3V 0C6
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Sleep Deprivation Study

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