跳至主要内容
临床试验/NCT05985512
NCT05985512招募中不适用

A Research on the Typing of Insomnia Disorder Based on Multidimensional Features

Shanghai Mental Health Center1 个研究点 分布在 1 个国家目标入组 216 人开始时间: 2023年3月1日最近更新:
适应症
干预措施

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.

研究组 & 干预措施

Insomnia Disorder

Other

Patients with insomnia disorder

干预措施: Cognitive Behavioral Therapy for Insomnia (Behavioral)

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

申办方类型
Other
责任方
Sponsor

研究点 (1)

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