Study on an Intelligent Model for the Diagnosis and Treatment of Insomnia Disorder
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 16,000
- 试验地点
- 5
- 主要终点
- The change of Pittsburgh Sleep Quality Index (PSQI) total scores from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months.
研究概览
简要总结
To establish a multicenter, multi-dimensional cohort on insomnia disorder and to develop an intelligent model for the diagnosis and treatment of insomnia disorder.
详细描述
The study endeavors to establish a multicenter cohort comprising 16,000 individuals diagnosed with insomnia disorder, with a subsequent 2-year follow-up. Objectives encompass elucidating the natural development of insomnia disorder within diverse populations, identifying associated factors, and evaluating the short-term and long-term impacts on physiological, psychological, and social functions in insomnia disorder. Additionally, the research aims to devise early screening methodologies, precise assessments, and innovative disease classifications utilizing real-time assessment technology within the insomnia disorder cohort. Furthermore, the investigation seeks to ascertain graded diagnoses, treatment modalities, and prognostic indicators based on advanced multi-dimensional real-time assessment technology applied to a substantial insomnia disorder cohort. Finally, the study aims to refine remote interactive diagnostic and treatment modalities tailored to diverse age groups, culminating in developing a systematic graded diagnostic and treatment framework for insomnia disorder.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A complaint of insomnia;
- •Age between 18 and 75;
- •Able to fill out the scale on their own;
- •Agree to sign the informed consent to participate in the study and cooperate in completing the follow-up visit.
排除标准
- •1.A current or history of comorbid Axis I psychiatric disorders.
结局指标
主要结局
The change of Pittsburgh Sleep Quality Index (PSQI) total scores from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months.
时间窗: Baseline, 3 months, 6 months, 12 months, 18 months, 24 months
The PSQI consists of 7 factors ranging from 0 to 3 points, and the total score ranges from 0 to 21 with higher scores indicating poorer quality.
次要结局
- The change of Epworth Sleepiness Scale (ESS) total scores from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months.(Baseline, 3 months, 6 months, 12 months, 18 months, 24 months)
- The change of PHQ-15 total scores from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months.(Baseline, 3 months, 6 months, 12 months, 18 months, 24 months)
- The change of Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS) total scores from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months.(Baseline, 3 months, 6 months, 12 months, 18 months, 24 months)
- The change of PDQ-D-5 total scores from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months.(Baseline, 3 months, 6 months, 12 months, 18 months, 24 months)
- The change of Life Events Scale (LES) total scores from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months.(Baseline, 3 months, 6 months, 12 months, 18 months, 24 months)
- The change of sleep onset latency from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months.(Baseline, 3 months, 6 months, 12 months, 18 months, 24 months)
- The change of total sleep time from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months.(Baseline, 3 months, 6 months, 12 months, 18 months, 24 months)
- The change of time in bed from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months.(Baseline, 3 months, 6 months, 12 months, 18 months, 24 months)
- The change of Short Form 36 (SF-36) total scores from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months.(Baseline, 3 months, 6 months, 12 months, 18 months, 24 months)
- The change of Insomnia severity index (ISI) total scores from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months.(Baseline, 3 months, 6 months, 12 months, 18 months, 24 months)
- The change of SHAPS total scores from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months.(Baseline, 3 months, 6 months, 12 months, 18 months, 24 months)
- The change of wake after sleep onset from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months.(Baseline, 3 months, 6 months, 12 months, 18 months, 24 months)
- The change of terminal wakefulness from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months.(Baseline, 3 months, 6 months, 12 months, 18 months, 24 months)
- The change of sleep efficiency from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months.(Baseline, 3 months, 6 months, 12 months, 18 months, 24 months)