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临床试验/NCT01132651
NCT01132651已完成不适用

Novel Use of a Cooling Pillow for Treatment of Severe Hand and Neck Atopic Dermatitis

Northwestern University2 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2010年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
9
试验地点
2
主要终点
Change in Sleep Quality as Measured by a Change in Pittsburgh Sleep Quality Index (PSQI) Survey Score

研究概览

简要总结

The purpose of this study is to see if using a cooling pillow at night will help sleep quality in people with atopic dermatitis (AD).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of AD by dermatologist
  • AD located on the head and neck
  • Investigator Global Assessment (IGA)score >3 at time of enrollment
  • Able to read, write, and understand study materials
  • Age 18 or older

排除标准

  • Concurrent non-AD skin disease on the head and neck
  • Active skin infection on the head and neck, or conditions that may interfere with evaluation of the skin

结局指标

主要结局

Change in Sleep Quality as Measured by a Change in Pittsburgh Sleep Quality Index (PSQI) Survey Score

时间窗: Baseline and at 2 weeks

The PSQI is a clinical survey used to measure sleep quality. Seven components related to sleep quality are scored: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction. Each component is scored on a scale of 0 to 3. A score of 0 is associated with better sleep quality and a score of 3 is associated with worse sleep quality. The seven component scores are summed to achieve a total PSQI score. The total PSQI score has a range of 0-21. A score of 0 is associated with better sleep quality and a score of 21 is associated with worse sleep quality. Buysse,D.J., Reynolds,C.F., Monk,T.H., Berman,S.R., \& Kupfer,D.J. (1989). The Pittsburgh Sleep Quality Index (PSQI): A new instrument for psychiatric research and practice. Psychiatry Research, 28(2), 193-213.

次要结局

  • Change in Severity of Atopic Dermatitis (AD) as Measured by a Change in Investigator Global Assessment (IGA) Score(Baseline and at 2 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dennis West

Professor in Dermatology and Pediatrics

Northwestern University

研究点 (2)

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