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CompletedNCT05560620Updated Sep 29, 2022

Sleep Deprivation Study

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

Phase
Not applicable
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
19 Years to 45 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Cognitive Change
  • Sleep Deprivation
  • Caffeine

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03

In context

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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
19 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
48 participants (actual)

Study arms

  • 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 · Other: Caffeine

  • 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 · Other: No Caffeine

  • 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

  • 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

Interventions

  • BehavioralSleep Deprivation

    Participants will be randomized into either the sleep deprivation group or the control group, who will sleep regularly.

  • OtherCaffeine

    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.

  • OtherNo Caffeine

    De-caffeinated coffee

06

What researchers measure

Primary outcomes

  1. Change in NeuroCatch® Platform 2 (NCP2), event-related potentials (ERPs) Amplitudes

    N100, P300 and N400 amplitude values

    Time frame: 2 days

  2. Change in NeuroCatch® Platform 2 (NCP2), event-related potentials (ERPs) Latencies

    N100, P300 and N400 latency values

    Time frame: 2 days

  3. 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

  4. 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

Secondary outcomes

  1. 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

  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)

    Cogstate accuracy (% of correct responses) and reaction time (ms) scores

    Time frame: 1 day

  3. Safety Measures

    Frequency, severity and type of AEs, ADEs, and DDs

    Time frame: 2 days

  4. Demographics

    Time frame: 1 day

  5. Medical History

    Time frame: 1 day

07

Study locations

1 site
  • HealthTech Connex Centre for Neurology Studies
    Surrey, British Columbia V3V 0C6, Canada
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 29, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05560620
Lead sponsor
NeuroCatch Inc.
Responsible party
Sponsor
First posted
Sep 29, 2022
Start date
Jun 3, 2022
Primary completion
Jul 26, 2022
Completion
Aug 1, 2022
Last update
Sep 29, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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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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