Prospective, Hybrid, Single-Center, Single-Arm Study to Characterize Sleep and Scratching Behavior in Adolescents and Adults With Atopic Dermatitis and Adults With Psoriasis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Scratch Movements
研究概览
简要总结
Pruritis is a common symptom in patients with atopic dermatitis and psoriasis. Patients with atopic dermatitis and psoriasis often report pruritis-associated sleep impairments and scratching behaviors during nighttime and the negative impact on their quality of life. However, nocturnal scratch behavior and sleep impairment are poorly understood due to the difficulties in quantifying these symptoms in patients' daily lives. This study deploys multiple technologies (polysomnography, video capture, wrist sensors, clinician-reported outcomes, and patient-reported outcomes) to develop and validate a wrist-based solution to quantify nocturnal scratch.
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
- 14 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Non-Atopic Dermatitis or Psoriasis-related sleep disorder (e.g., diagnosed sleep apnea, restless leg syndrome etc...)
- •Movement disorder
- •Flare or infection on the wrist
- •Infected atopic dermatitis or psoriasis lesions
- •Pregnant or lactating women
- •Shift workers or participants with jetlag
- •Current diagnosis of depression
结局指标
主要结局
Scratch Movements
时间窗: 14 days
To evaluate the agreement in the detection of scratching behaviour between video annotation and wrist-based sensor
Sleep Time
时间窗: 14 days
To evaluate the agreement in the detection of sleep patterns between polysomnography and wrist-based sensor
次要结局
未报告次要终点