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临床试验/NCT04841083
NCT04841083已完成不适用

A Real World Evaluation of the Allay Lamp in Reducing Headache Symptoms and Frequency

Vedanta Research1 个研究点 分布在 1 个国家目标入组 182 人开始时间: 2020年12月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
182
试验地点
1
主要终点
Change in headache severity

研究概览

简要总结

Study volunteers are asked to use the Allay Lamp routinely during the 6-week study period. A web based survey is provided when the Lamp is purchased for study volunteers to complete. A daily usage paper diary is sent with the lamp so that volunteers can keep track of the frequency and duration of lamp usage and any noticeable benefits. At the end of six weeks a second survey is sent to study volunteers to capture their perceptions of potential lamp benefits with respect to headache frequency and their experience of migraine specific symptoms.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Adults with headaches or migraines.

排除标准

  • •Not having headaches or migraines

研究组 & 干预措施

Allay lamp (narrow band green light)

Experimental

Subjects who purchased the Allay Lamp are asked to document the effects of spending time in the narrow band of green light it emits, on their headache or any of its associated symptoms.

干预措施: Allay Lamp (Device)

结局指标

主要结局

Change in headache severity

时间窗: Changes from baseline at 6 weeks of using the Allay lamp

Assessing headache severity while using the Allay lamp. Improvement is determined by the number of times participants answer Yes or NO in their daily diary.

Change in number of headache days per month

时间窗: Changes from baseline at weeks 3-6 of using the Allay lamp

Number of days with headache per month without and with using the Allay lamp

Change in number of headache days per week

时间窗: Change from baseline at 6 weeks

Number of days with headache per week without and with using the Allay lamp

Change in frequency of experiencing photophobia

时间窗: Changes from baseline at 6 weeks of using the Allay Lamp.

Assessing frequency of photophobia during days with headache as depicted by participants using the following options: (1)never, rarely, (2)less than half, (3)half or more, (4)nearly all the time.

次要结局

未报告次要终点

研究者

发起方
Vedanta Research
申办方类型
Other
责任方
Principal Investigator
主要研究者

Michael Reed

Managing Director

Vedanta Research

研究点 (1)

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