NCT05524922招募中不适用
A Registered Observational Cohort Study on Neurodegenerative Associated With Sleep Disorder.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- PSQI Scores
研究概览
简要总结
Cognitive impairment often appears in neurodegenerative diseases, and it is expected to further study the mechanism of sleep disorders associated with the progression of neurodegenerative diseases by exploring the clinical manifestations, imaging, and biological marker changes of sleep disorders in neurodegenerative diseases.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinical diagnosis of neurodegenerative disease.
- •patients experience insomnia, excessive drowsiness, or confusion at night.
- •Patients experience frequent awakenings, daily sleep episodes, or nocturnal confusion.
- •The presence of one or more of the following characteristics: a. wandering at night with inappropriate activity; b. agitation, combativeness; c. confusion, disorientation, or marked delirium.
- •Polysomnographic monitoring showed the following two conditions: a. poor sleep efficiency, increased number and duration of awakenings; b. multiple sleep latency tests showed increased daytime sleepiness.
- •Presence of other medical symptoms that do not indicate the primary disease.
- •Other sleep disorders (e.g., periodic limb movement disorders, obstructive sleep apnea syndrome) may be present, but do not explain the patient 's main symptoms.
- •any of the above can be diagnosed
排除标准
- •Patients with other neurological disorders.
- •Pregnant or lactating women.
结局指标
主要结局
PSQI Scores
时间窗: Baseline
Pittsburgh Sleep Quality Index (PSQI),
次要结局
- Vic(1 year after baseline)
- Plasma Aβ-42 levels (ng/ml)(Baseline)
- ACE-III scores(Baseline)
- MoCA scores(Baseline)
- HRV (ms)(Baseline)
- PAF (Hz)(Baseline)
研究者
研究点 (1)
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