A Multicenter, Non-Drug Interventional Study for the Technical Development and Validation of the Nocturnal Scratch Algorithm for Use in Future Programs
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 16
- 试验地点
- 6
- 主要终点
- Total Scratch Duration Per Night
研究概览
简要总结
Sleep disturbance is very common in patients with atopic dermatitis (AD) and is a major factor leading to impaired quality of life. Nocturnal scratching is one of the factors causing sleep disturbance in AD patients. This study aims to develop and validate a digital algorithm for accurately and reliably detecting and quantifying nocturnal scratch behaviors related to AD using wrist actigraphy data.
Wrist actigraphy is an investigational device being developed to detect and quantify scratching behaviors in patients with AD. This study will be conducted in 2 sequential stages: In Stage 1, an algorithm will be developed and in Stage 2 the algorithm developed will be validated. Adult healthy volunteers or participants with AD will be enrolled. Approximately 14 healthy volunteers, 14 AD patients with low disease activity and 28 AD patients with high disease activity will be enrolled in the study in 5 sites across the United States.
No drug will be administered as a part of this study.
Participants enrolled in this study may experience discomfort or inconvenience related to the study procedures. Participants will be enrolled and monitored overnight for two consecutive nights at an inpatient setting at a hospital or clinic. The impact of nocturnal scratching on sleep parameters will be assessed by videography, actigraphy, sleep headband and completing questionnaires.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Diagnostic
- 盲法
- None
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
- 是
入选标准
- •Volunteers in general good health with no diagnosis of AD or any other dermatologic disorder that interferes with study assessments.
- •For subjects with AD:
- •Chronic AD with onset of symptoms at least 1 year prior to Day 1 and participant meets American Academy of Dermatology (AAD) criteria.
- •Participant meets all of the following disease activity criteria:
- •For AD subjects with high disease activity (AD-High):
- •Pruritus over the last 7 days (numerical rating scale 7-Day version [NRS-7]) >= 4 at the Screening and Day 1 visits.
- •At least one of the following:
- •Eczema Area and Severity Index (EASI) score > 7 at the Screening and Day 1 visits; OR
- •Validated Investigator Global Assessment for AD (vIGA-AD) score >= 3 at the Screening and Day 1 visits;
- •For AD subjects with low disease activity (AD-Low):
- •Pruritus over the last 7 days (NRS-7) >= 2 at the Screening and Day 1 visits.
- •Does not meet AD-High criteria as described.
- •Satisfy at least one of the following:
- •EASI score >= 3 at the Screening and Day 1 visits OR
- •vIGA-AD score >= 1 at the Screening and Day 1 visits.
排除标准
- •Significant eczema on wrists where devices will be worn that, in the opinion of the participant or investigator would likely lead to non-compliance.
- •Interference (e.g., hairstyle) with the ability of Dreem 2 headband to collect sensor data.
- •Unstable medical disorder or other condition that in the investigator's opinion may interfere with study procedures or study objectives.
结局指标
主要结局
Total Scratch Duration Per Night
时间窗: Up to 10 Days
Total scratch duration per night (seconds/night) is measured by actigraphy and videography.
次要结局
- Scratch Duration(Up to 10 Days)
- Comparison of Actigraphy-Based Scratches to Videography-Based Scratches(Up to 10 Days)
- Number of Scratching Events(Up to 10 Days)
- Scratch Rate(Up to 10 Days)