跳至主要内容
临床试验/NCT05524922
NCT05524922
招募中
不适用

A Registered Observational Cohort Study on Neurodegenerative Associated With Sleep Disorder.

Fujian Medical University Union Hospital1 个研究点 分布在 1 个国家目标入组 500 人2021年9月1日

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.

注册库
clinicaltrials.gov
开始日期
2021年9月1日
结束日期
2030年6月1日
最后更新
去年
研究类型
Observational
性别
All

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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