NCT06558929进行中（未招募）不适用
Evaluating the Effectiveness of Intervention Based on the Model of Occupational Harmony in Patients With Sleep Disorders
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Pittsburgh Sleep Quality Index
研究概览
简要总结
The goal of this clinical trial is to learn the effectiveness of an intervention based on the Model of Occupational Harmony (MOHar) in treating patients with sleep disorders. The main questions it aims to answer are:
- Does intervention based on the MOHar improve sleep quality in patients with sleep disorders?
- Does intervention based on the MOHar improve the quality of life in patients with sleep disorders?
Researchers will compare the intervention based on the MOHar to conventional treatment to see if the intervention works to treat sleep disorders.
Participants will:
- Participate in an occupational therapy program for 6 weeks (including group therapy, individual treatment, and daily occupational tasks)
- Complete questionnaires at 1, 3, and 6 months after the program for follow-up
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥18 years of age
- •self-reported difficulties with sleep quality
- •active sleep disturbance as indicated by a PSQI > 5 or an ISI ≥ 8 at screening
- •able to participate in research independently or with the assistance of a caregiver
- •participate voluntarily in the study and sign an informed consent form
排除标准
- •unable to cooperate with the study process due to cognitive, sensory, and motor dysfunction
- •unable to skillfully use wearable monitoring devices or smartphones
- •diagnosed with severe cardiac, liver, and kidney dysfunction and nervous system diseases
- •have cardiac pacemakers
- •being pregnant
- •participating in other clinical trials
结局指标
主要结局
Pittsburgh Sleep Quality Index
时间窗: 6 months
Using the PSQI to measure sleep quality
Insomnia Severity Index
时间窗: 6 months
Using the ISI to measure sleep quality
36-Item Short Form Survey (SF-36)
时间窗: 6 months
Using the SF-36 to measure quality of life
次要结局
未报告次要终点
研究者
研究点 (2)
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