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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sleep Deprivation | Behavioral | Participants will be randomized into either the sleep deprivation group or the control group, who will sleep regularly. |
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| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HealthTech Connex Centre for Neurology Studies | Surrey | British Columbia | V3V 0C6 | Canada |
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| ID | Term |
|---|---|
| D012892 | Sleep Deprivation |
| ID | Term |
|---|---|
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D002110 | Caffeine |
| ID | Term |
|---|---|
| D014970 | Xanthines |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011688 | Purinones |
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2-group, randomized design
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| 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. |
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| No Caffeine | Other | De-caffeinated coffee |
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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 |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
| D011687 |
| Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |