NCT05985512招募中不适用
A Research on the Typing of Insomnia Disorder Based on Multidimensional Features
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 216
- 试验地点
- 1
- 主要终点
- polysomnography
研究概览
简要总结
Based on real world and focusing on patients with chronic sleep disorders, this study conducts a data-driven subtyping research on the clinical symptoms, polysomnography, near-infrared scanning, molecular genetics, and other characteristics of chronic insomnia disorders. It constructs a multimodal therapeutic outcome prediction model, providing a basis for personalized interventions for chronic insomnia 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
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 18 and 65 years, regardless of gender;
- •Currently meeting the diagnostic criteria for insomnia disorder according to the Fifth Edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5);
- •Pittsburgh Sleep Quality Index (PSQI) total score ≥ 10;
- •Sufficient level of education and comprehension to complete the required examinations and assessments for this study;
- •Voluntarily participating in this research and signing the informed consent form.
排除标准
- •Currently diagnosed with other sleep disorders (sleep-related breathing disorders, periodic limb movement disorder, parasomnias, central disorders of hypersomnolence, circadian rhythm sleep-wake disorders, etc.);
- •Currently diagnosed with organic brain diseases (epilepsy, cerebrovascular disease, etc.) or other organic diseases;
- •Patients with a history of or currently diagnosed with bipolar and related disorders, obsessive-compulsive and related disorders, schizophrenia spectrum and other psychotic disorders, trauma and stressor-related disorders, dissociative disorders, or eating disorders;
- •Women who are pregnant, breastfeeding, or planning to become pregnant during the study period;
- •Insomnia caused by alcohol or substance abuse;
- •High suicide risk, with HAMD-17 suicide factor score > 2;
- •Inability to cooperate with near-infrared examinations and polysomnography due to physical conditions such as head injury, etc.
结局指标
主要结局
polysomnography
时间窗: the end of the eighth week
change in total sleep time recorded by polysomnography
PSQI
时间窗: the end of the 24th, 36th, 48th week
change in total sleep time according to PSQI scale
次要结局
未报告次要终点
研究者
研究点 (1)
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