Effects of Acute Sleep Deprivation on Individuals With Different APOE Genotypes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Plasma Aβ42 levels
研究概览
简要总结
This study aims to investigate the effects of 24-hour acute sleep deprivation on plasma Alzheimer's disease biomarkers and multi-omics in individuals with different APOE genotypes, to elucidate the potential role of acute sleep deprivation in AD risk.
详细描述
This is a randomized controlled trial designed to enroll 60 healthy volunteers. Stratified randomization will be used, with three strata defined by APOE genotype (APOE ε3/3, APOE ε4 carriers, and APOE ε2 carriers) in a 1:1:1 ratio. Within each stratum, participants will be randomly assigned in a 1:1 ratio to either the acute sleep-deprivation group or the non-acute sleep-deprivation group. The intervention will consist of 24 hours of acute sleep deprivation. The primary outcome measure is the change from baseline in plasma Aβ42 on the first day after randomization.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-40 years, gender not limited
- •Healthy (with no clinically significant abnormal findings in the physical examination report or self-reporting as healthy) and not on medications
- •Cognitively normal (Mini-Mental State Examination (MMSE) score > 28)
- •Sleep duration of 7-9 hours per night, good sleep quality (Pittsburgh Sleep Quality Index (PSQI) ≤ 5 points)
- •Written informed consent, voluntarily participate in this study, and be able to cooperate with the physician to complete the clinical study
排除标准
- •Presence of day-night sleep reversal
- •Shift work within the past 6 months
- •Travel across time zones or experience of jet lag within the past three weeks
- •Current smoking or nicotine use; alcohol consumption exceeding five standard units per week (one standard alcohol unit is defined as 10 mL [or 8 g] of pure alcohol)
- •Consumption of strong tea, coffee, or caffeine-containing foods and beverages within one week before study participation
- •Family history of early-onset dementia
- •Self-Rating Depression Scale (SDS) score ≥ 53, Self-Rating Anxiety Scale (SAS) score ≥ 50
- •Female participants who are currently pregnant or breastfeeding
- •Individuals who need to drive or operate vehicles or machinery during the study period
结局指标
主要结局
Plasma Aβ42 levels
时间窗: 1 day after randomization
Plasma Aβ42 levels
时间窗: 1 day after randomization
次要结局
- Plasma Aβ40 levels(1 day after randomization)
- Plasma t-tau levels(1 day after randomization)
- Plasma NfL levels(1 day after randomization)
- Plasma GFAP levels(1 day after randomization)
- Plasma Aβ40 levels(1 day after randomization)
- Plasma t-tau levels(1 day after randomization)
- Plasma p-tau181 levels(1 day after randomization)
- Plasma p-tau217 levels(1 day after randomization)
- Plasma NfL levels(1 day after randomization)
- Plasma GFAP levels(1 day after randomization)
- Plasma Aβ42/Aβ40 levels(1 day after randomization)
- Plasma t-tau/Aβ42 levels(1 day after randomization)
- Plasma p-tau181/Aβ42 levels(1 day after randomization)
- Plasma p-tau217/Aβ42 levels(1 day after randomization)
- Fatigue Scale-14(1 day after randomization)
- Positive and Negative Affect Schedule(1 day after randomization)
- N-back tasks(1 day after randomization)
研究者
Yuhui Qiu
Principal Investigator
Guangdong Provincial Hospital of Traditional Chinese Medicine