The Relationship Between Moderate-to-severe Psoriasis and Sleep Disturbance: a Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 156
- 试验地点
- 1
- 主要终点
- Pittsburgh sleep quality index (PSQI)
研究概览
简要总结
Psoriasis is a common chronic and systemic immune-mediated disease, induced by a combination of genetic and environmental effects. The increasingly worrying question is the negative impact on patients' sleep, which has become an important comorbidity of psoriasis. To investigate the causal relationship between psoriasis and sleep status, a prospective cohort study will be conducted by separating moderate-to-severe psoriasis patients and healthy individuals into distinct cohorts in order to observe their sleep status.
详细描述
Target follow-up duration for the study is 24 weeks, during which participants will undergo a sleep monitoring session every 8 weeks. The sleep monitoring data collected includes time to fall asleep, time to bed, sleep perception, and the Pittsburgh Sleep Quality Index (PSQI). The Dermatology Quality of Life Index (DLQI), the Psoriasis Area and Severity Index (PASI), and the Visual Analog Scale (VAS) will simultaneously be used to assess the severity of the disease in the cohort of patients with psoriasis.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •In line with the diagnostic criteria of psoriasis
- •PASI>10 or BSA>10%
- •Understand and agree to participate in this study and sign the informed consent.
排除标准
- •Those with serious mental diseases, such as depression, anxiety, etc;
- •PSQI>5 points;
- •Long term use of sedative and hypnotic drugs;
- •Patients with diabetes mellitus or severe heart, liver and kidney disease;
- •Those diagnosed with sleep disorders, such as apnea syndrome, periodic limb movement disorder, restless legs syndrome, narcolepsy, etc;
- •There are serious cardiovascular and cerebrovascular diseases, respiratory system diseases, and immune system diseases;
- •Pregnant women during pregnancy, lactation, or planned trials;
- •Those who have participated in other clinical studies or are participating in other clinical trials within 3 months;
- •Unable to cooperate with the study for any reason, such as the following situation: language understanding, unable to complete the scale tester.
- •If any one of the above items is met, it shall be excluded.
结局指标
主要结局
Pittsburgh sleep quality index (PSQI)
时间窗: week0、week8、week16、week24
PSQI is a 19-item self-rated questionnaire for evaluating subjective sleep quality over the previous month. A score above 5 suggests poor sleep quality.
次要结局
- Visual Analogue Scale (VAS)(week0、week8、week16、week24)
- Dermatology Life Quality Index (DLQI)(week0、week8、week16、week24)
- Psoriasis Area and Severity Index (PASI)(week0、week8、week16、week24)
- Hospital Anxiety and Depression Scale(HADS）(week0、week8、week16、week24)