Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
48 participants
INTERVENTIONAL
2022-06-03
2022-08-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
SINGLE
Study Groups
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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.
Sleep Deprivation
Participants will be randomized into either the sleep deprivation group or the control group, who will sleep regularly.
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.
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.
Sleep Deprivation
Participants will be randomized into either the sleep deprivation group or the control group, who will sleep regularly.
No Caffeine
De-caffeinated coffee
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.
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.
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.
No Caffeine
De-caffeinated coffee
Interventions
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Sleep Deprivation
Participants will be randomized into either the sleep deprivation group or the control group, who will sleep regularly.
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.
No Caffeine
De-caffeinated coffee
Eligibility Criteria
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Inclusion Criteria
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
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
19 Years
45 Years
ALL
Yes
Sponsors
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NeuroCatch Inc.
INDUSTRY
Responsible Party
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Locations
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HealthTech Connex Centre for Neurology Studies
Surrey, British Columbia, Canada
Countries
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Other Identifiers
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NCI_NCClin_006
Identifier Type: -
Identifier Source: org_study_id
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