NCT02853487已完成不适用
Circadian Rhythm and Attack-timing in Episodic Cluster Headache Patients in- and Outside of Bout: an Actigraphic Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Circadian rhythm
研究概览
简要总结
The aim is to investigate circadian rhythm in episodic cluster headache using actigraphy.
详细描述
The aim is to investigate circadian rhythm in episodic cluster headache patients in- and outside of bout. This will be done using actigraphy and a short diary for 2 weeks in each period. A secondary outcome is to look at attack occurence and physical activity before and during an attack.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- •Age between 18 and 65 years of age
- •Episodic cluster headache
- •The patient can differentiate cluster headache from other primary headaches if he suffers from any.
排除标准
- •Circumstances, determined by the PI, that makes the patient ineligible.
- •Changes in preventive medication within 7 days before the study initiation and during the 2 weeks.
- •Changes in antidepressive medication or antipsychotic medication within 2 weeks before the study initiation and during the 2 weeks.
- •Serious somatic and/or psychiatric disorders
- •Alcohol intake > 50 units pr.week
- •Pregnancy / breastfeeding
- •Patient cannot accept the conditions of the trial
- •Patient does not understand Danish.
- •Inclusion Criteria:
- •Age between 18 and 65 years of age
- •Exclusion Criteria:
- •Circumstances, determined by the PI, that makes the patient ineligible.
- •Any primary headache more than 1 day / month
- •Diagnosed with a secondary headache
- •Treatment with antidepressive medication or antipsychotic medication within 2 weeks before the study initiation and during the 2 weeks.
- •Serious somatic and/or psychiatric disorders
- •Alcohol intake > 14 / 7 units pr.week (males / females)
- •Pregnancy / breastfeeding
- •Patient cannot accept the conditions of the trial
- •Patient does not understand Danish.
结局指标
主要结局
Circadian rhythm
时间窗: Circadian rhythm is assessed after 2 weeks
After 2 weeks of actigraphy, the circadian rhythm will be assessed using "Philips Actiware 6" program.
次要结局
- Physical activity before and during an attack(Increase / decrease in activity count will be described after 2 weeks.)
- Attack occurence(The time of day will be assessed after 2 weeks)
研究者
MD, Ph.d.-student Nunu Lund
MD, PhD-student
Danish Headache Center
研究点 (1)
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