Sleep Deprivation Study

Cognitive Change Clinical Trial

Official title:

Impact of Sleep Deprivation on Objective, Physiological Measures of Brain Function Cognition

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05560620
• Other study ID #: NCI_NCClin_006
• Status: Completed
• Phase: N/A
• Start date: June 3, 2022
• Est. completion date: August 1, 2022

Study information

• Verified date: September 2022
• Source: NeuroCatch Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: August 1, 2022
• Est. primary completion date: July 26, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 45 Years

Eligibility

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:

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

Related Conditions & MeSH terms

• Caffeine
• Cognitive Change
• Sleep Deprivation

Intervention

Behavioral:
• Sleep Deprivation
Participants will be randomized into either the sleep deprivation group or the control group, who will sleep regularly.

Other:
• 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

Locations

Country	Name	City	State
Canada	HealthTech Connex Centre for Neurology Studies	Surrey	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
NeuroCatch Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in NeuroCatch® Platform 2 (NCP2), event-related potentials (ERPs) Amplitudes	N100, P300 and N400 amplitude values	2 days
Primary	Change in NeuroCatch® Platform 2 (NCP2), event-related potentials (ERPs) Latencies	N100, P300 and N400 latency values	2 days
Primary	Change in Cogstate cognitive assessment Accuracy scores from Baseline, Baseline 2 and Study Visit 3 (post-intervention)	accuracy (% of correct responses) scores	2 days
Primary	Change in Cogstate cognitive assessment Reaction time scores from Baseline, Baseline 2 and Study Visit 3 (post-intervention)	reaction time (ms) scores	2 days
Secondary	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
Secondary	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	1 day
Secondary	Safety Measures	Frequency, severity and type of AEs, ADEs, and DDs	2 days
Secondary	Demographics		1 day
Secondary	Medical History		1 day