NCT05524922
招募中
不适用
A Registered Observational Cohort Study on Neurodegenerative Associated With Sleep Disorder.
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Neurodegenerative Disorder
- 发起方
- Fujian Medical University Union Hospital
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- PSQI Scores
- 状态
- 招募中
- 最后更新
- 去年
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.
研究者
入排标准
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)
研究点 (1)
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