NCT06797284招募中不适用
The Impact of Light, Electrical, and Magnetic Neuroregulation Interventions on Sleep-wake Disorders
Second Affiliated Hospital of Soochow University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年2月1日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Objective sleep indicators and clinical sleep-related scales
研究概览
简要总结
Carry out precise and effective neuromodulation interventions, and develop new neuromodulation technologies for sleep disorders. Use phototherapy, transcranial electrical/magnetic stimulation and other therapies to conduct self-controlled intervention studies on insomnia, narcolepsy, and rapid eye movement sleep behavior disorder .
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with insomnia, narcolepsy,and RBD that have been clearly diagnosed by specialists should sign the informed consent form.
排除标准
- •Patients with major neurological diseases such as multi-infarct dementia, Huntington's disease, normal pressure hydrocephalus, brain tumors, progressive supranuclear palsy, epilepsy, subdural hematoma, multiple sclerosis, or those who have sustained neurological dysfunction or known structural brain abnormalities after significant head trauma are excluded.
- •A history of major depressive disorder or bipolar disorder within the past year, as defined in DSM-IV criteria. A history of schizophrenia (meeting DSM-IV criteria).
- •History of severe drug or alcohol abuse within the past year;
- •Any significant systemic illness or unstable medical condition that may make it difficult to comply with the protocol, such as severe autoimmune diseases or a history of cancer.
- •Have significant hearing, visual, or cognitive impairments, or are unable to participate in interviews in a meaningful way.
结局指标
主要结局
Objective sleep indicators and clinical sleep-related scales
时间窗: From enrollment to the end of treatment at 4 weeks
次要结局
- Resting-state electroencephalogram, resting-state functional magnetic resonance imaging, blood biochemical indicators(From enrollment to the end of treatment at 4 weeks)
研究者
Chun-Feng Liu
professor
Second Affiliated Hospital of Soochow University
研究点 (1)
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