Cognitive ChangeNCT05560620
Sleep Deprivation Study
A study testing Sleep Deprivation, Caffeine and No Caffeine in people with Cognitive Change and Sleep Deprivation, run by NeuroCatch Inc. at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Change, Sleep Deprivation, Caffeine
- What is being tested?
- Sleep Deprivation, Caffeine and No Caffeine
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteCanada
- Study dates
- 3 Jun 2022to 1 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Show all 12Show fewer
- 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.)
Who cannot join
- 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.
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
HealthTech Connex Centre for Neurology Studies
Surrey, British Columbia, V3V 0C6
About this study
Official title: Impact of Sleep Deprivation on Objective, Physiological Measures of Brain Function Cognition
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.
- Conditions
- Cognitive Change, Sleep Deprivation, Caffeine
- Being tested
- Sleep Deprivation, Caffeine, No Caffeine
- Medical subject headings
- Sleep Deprivation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep DeprivationBehavioural
Participants will be randomized into either the sleep deprivation group or the control group, who will sleep regularly.
CaffeineOther
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 CaffeineOther
De-caffeinated coffee
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Sleep Deprivation; Other: Caffeine |
| 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. Receives: Behavioral: Sleep Deprivation; Other: No Caffeine |
| 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. Receives: Other: Caffeine |
| 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. Receives: Other: No Caffeine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in NeuroCatch® Platform 2 (NCP2), event-related potentials (ERPs) Amplitudes
N100, P300 and N400 amplitude values
Measured: 2 days
Change in NeuroCatch® Platform 2 (NCP2), event-related potentials (ERPs) Latencies
N100, P300 and N400 latency values
Measured: 2 days
Change in Cogstate cognitive assessment Accuracy scores from Baseline, Baseline 2 and Study Visit 3 (post-intervention)
accuracy (% of correct responses) scores
Measured: 2 days
Change in Cogstate cognitive assessment Reaction time scores from Baseline, Baseline 2 and Study Visit 3 (post-intervention)
reaction time (ms) scores
Measured: 2 days
Secondary outcomes (5)
Change in NeuroCatch® Platform 2 (NCP2), event-related potentials (ERPs) pre and post caffeine intervention
N100, P300 and N400 amplitude and latency values
Measured: 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
Measured: 1 day
Safety Measures
Frequency, severity and type of AEs, ADEs, and DDs
Measured: 2 days
Demographics
Measured: 1 day
Medical History
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2022
- Study start3 Jun 2022
- Primary completion26 Jul 2022
- Study completion1 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ChangeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2-group, randomized design
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- NeuroCatch Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05560620
- Sponsor's protocol ID
- NCI_NCClin_006
- Status last verified
- Sep 2022
- First submitted
- 7 Jun 2022
- Last updated
- 29 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Sleep Deprivation on Objective, Physiological Measures of Brain Function Cognition
- ClinicalTrials.gov ID
- NCT05560620
- Acronym / sponsor ID
- NCI_NCClin_006
- Conditions
- Cognitive Change, Sleep Deprivation, Caffeine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- NeuroCatch Inc.Industry (pharma, biotech, devices)
- Study start
- 3 Jun 2022 (actual)
- Primary completion
- 26 Jul 2022 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 29 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- 2-group, randomized design
| Arm | Type | Receives |
|---|---|---|
| Sleep Deprivation and Caffeine Intervention | Experimental | Behavioral: Sleep Deprivation, Other: CaffeineParticipants 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 and no Caffeine intervention | Sham comparator | Behavioral: Sleep Deprivation, Other: No CaffeineParticipants randomized into the sleep deprivation group and then randomized into receiving de-caffeinated coffee the next morning. Participant is blinded to the caffeine intervention. |
| Control and Caffeine | Active comparator | Other: CaffeineParticipants 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. |
| Control and No Caffeine | Sham comparator | Other: No CaffeineParticipants 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. |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleep DeprivationParticipants will be randomized into either the sleep deprivation group or the control group, who will sleep regularly. | Behavioural | Sleep Deprivation and Caffeine Intervention, Sleep Deprivation and no Caffeine intervention |
| CaffeineOn 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. | Other | Control and Caffeine, Sleep Deprivation and Caffeine Intervention |
| No CaffeineDe-caffeinated coffee | Other | Control and No Caffeine, Sleep Deprivation and no Caffeine intervention |
Primary outcome
Change in NeuroCatch® Platform 2 (NCP2), event-related potentials (ERPs) Amplitudes
Time frame: 2 days
N100, P300 and N400 amplitude values
Change in NeuroCatch® Platform 2 (NCP2), event-related potentials (ERPs) Latencies
Time frame: 2 days
N100, P300 and N400 latency values
Change in Cogstate cognitive assessment Accuracy scores from Baseline, Baseline 2 and Study Visit 3 (post-intervention)
Time frame: 2 days
accuracy (% of correct responses) scores
Change in Cogstate cognitive assessment Reaction time scores from Baseline, Baseline 2 and Study Visit 3 (post-intervention)
Time frame: 2 days
reaction time (ms) scores
5 secondary outcomes
Change in NeuroCatch® Platform 2 (NCP2), event-related potentials (ERPs) pre and post caffeine intervention
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)
Time frame: 1 day
Safety Measures
Time frame: 2 days
Demographics
Time frame: 1 day
Medical History
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Cognitive Change
Recruiting
A Clinical Trial to Evaluate the Effects of Adrenal Adapt on Sleep Quality, Daytime Energy, Stress Resilience, and Cognitive Performance.
Improves Daytime Energy Levels, Reduces Afternoon Energy Crashes and Midday Fatigue
RecruitingObservational study
Looking at Cognitive and Brain Changes in People With Lymphoma Receiving CAR-T Therapy
Lymphoma Receiving CAR-T Therapy
Recruiting
Milk Fat Globule Membrane-Enhanced RUTF for Children With Severe Acute Malnutrition
Severe Acute Malnutrition, Cognitive Impairment
Enrolling by invitation
Brain Heath Service for Prevention of AD
Alzheimer, Cognitive Unimpaired
Enrolling by invitation
Effects of Long-Duration Spaceflight on General and Spatial Cognition and Its Neural Basis
Brain Structure, Cognitive Performance
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep Deprivation, Caffeine and No Caffeine in people with Cognitive Change and Sleep Deprivation, run by NeuroCatch Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in NeuroCatch® Platform 2 (NCP2), event-related potentials (ERPs) Amplitudes (time frame: 2 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2022.