Sleep in Cluster Headache: Sleep Parameters in- and Outside a Cluster Bout
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Compare the macrostructure of sleep in episodic cluster headache patients in bout with in remission
研究概览
简要总结
Sleep study in episodic cluster headache patients.
详细描述
This is an explorative study that aims to describe the sleep in 30 episodic cluster headache patients in- and outside of cluster using polysomnography. Data will be compared to a group of healthy controls.
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
- 否
入选标准
- •Age between 18 and 65 years of age
- •Episodic cluster headache according to ICHD-III beta
- •Ability to differentiate attacks of other primary headaches from cluster headache.
- •1-8 daily attacks
- •Cluster bouts normally lasting more than 2 weeks
排除标准
- •Treatment with psychiatric medication other than lithium.
- •Pregnancy or breastfeeding
- •Serious somatic or psychiatric disorders
- •Chronic primary or secondary headache
- •Alcohol intake higher than 14 units a week for males and 7 units a week for females.
- •Cannot accept the conditions of the trial.
- •Does not understand Danish.
结局指标
主要结局
Compare the macrostructure of sleep in episodic cluster headache patients in bout with in remission
时间窗: From study initiation to January 2018
Compare apnea-hypopnea index during one night of polysomnography using mixed models analyses.
Compare the macrostructure of sleep in episodic cluster headache patients with healthy controls
时间窗: From study initiation to January 2018
Compare sleep latency (minutes) during one night of polysomnography using mixed models analyses.
次要结局
- The presence of any sleep disorders in patients and controls(From study initiation to January 2018)
研究者
MD, Ph.d.-student Nunu Lund
MD
Danish Headache Center