NCT05560620已完成不适用
Impact of Sleep Deprivation on Objective, Physiological Measures of Brain Function Cognition
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Change in Cogstate cognitive assessment Accuracy scores from Baseline, Baseline 2 and Study Visit 3 (post-intervention)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 19 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Any sex, between the ages of 19 and
- •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)
- •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.)
排除标准
- •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.
- •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:
- •Requires use of hearing aids or a cochlear implant 17.
- •Diagnosed with tinnitus that is currently active 17.
- •Temporary damage to hearing (e.g. punctured ear drum). 17.
- •Implanted pacemaker or implanted electrical stimulators 17.
- •Metal or plastic implants in the skull, excluding dental/facial implants. 17.
- •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.
- •Not proficient in the English language 17.
- •Diagnosed epilepsy or history of seizures 17.
- •If female and of child-bearing potential: pregnant, suspected or planning to become pregnant or breast-feeding 17.
- •Unhealthy scalp (apparent open wounds and/or bruised or weakened skin) 17.
- •Allergy to EEG gel
结局指标
主要结局
Change in Cogstate cognitive assessment Accuracy scores from Baseline, Baseline 2 and Study Visit 3 (post-intervention)
时间窗: 2 days
accuracy (% of correct responses) scores
Change in NeuroCatch® Platform 2 (NCP2), event-related potentials (ERPs) Amplitudes
时间窗: 2 days
N100, P300 and N400 amplitude values
Change in NeuroCatch® Platform 2 (NCP2), event-related potentials (ERPs) Latencies
时间窗: 2 days
N100, P300 and N400 latency values
Change in Cogstate cognitive assessment Reaction time scores from Baseline, Baseline 2 and Study Visit 3 (post-intervention)
时间窗: 2 days
reaction time (ms) scores
次要结局
- Demographics(1 day)
- Safety Measures(2 days)
- Change in NeuroCatch® Platform 2 (NCP2), event-related potentials (ERPs) pre and post caffeine intervention(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)(1 day)
- Medical History(1 day)
研究者
研究点 (2)
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