An interventional study of Sleep Deprivation and Caffeine in Cognitive Change, Sleep Deprivation and Caffeine, sponsored by NeuroCatch Inc.. Completed at 1 site in Canada. Open to participants aged 19 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-09-29.
Sponsored by NeuroCatch Inc. · Not applicable, Interventional, and Basic science
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.
300 studies on the registry are indexed under Sleep Deprivation; 60 are open to participants now.
This study's enrollment of 48 is close to the median of 45 across 248 interventional studies indexed under Sleep Deprivation.
Browse Sleep Deprivation studies →NeuroCatch Inc. is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
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
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
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
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
Participants will be randomized into either the sleep deprivation group or the control group, who will sleep regularly.
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.
De-caffeinated coffee
Change in NeuroCatch® Platform 2 (NCP2), event-related potentials (ERPs) Amplitudes
N100, P300 and N400 amplitude values
Time frame: 2 days
Change in NeuroCatch® Platform 2 (NCP2), event-related potentials (ERPs) Latencies
N100, P300 and N400 latency values
Time frame: 2 days
Change in Cogstate cognitive assessment Accuracy scores from Baseline, Baseline 2 and Study Visit 3 (post-intervention)
accuracy (% of correct responses) scores
Time frame: 2 days
Change in Cogstate cognitive assessment Reaction time scores from Baseline, Baseline 2 and Study Visit 3 (post-intervention)
reaction time (ms) scores
Time frame: 2 days
Change in NeuroCatch® Platform 2 (NCP2), event-related potentials (ERPs) pre and post caffeine intervention
N100, P300 and N400 amplitude and latency values
Time frame: 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)
Cogstate accuracy (% of correct responses) and reaction time (ms) scores
Time frame: 1 day
Safety Measures
Frequency, severity and type of AEs, ADEs, and DDs
Time frame: 2 days
Demographics
Time frame: 1 day
Medical History
Time frame: 1 day
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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NeuroCatch Inc.