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临床试验/NCT03010189
NCT03010189已完成不适用

Actigraphy and Nocturnal Heartrate Variability in Cluster Headache Patients

Nordlandssykehuset HF2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2017年1月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
Change in total sleep time

研究概览

简要总结

Cluster headache is one of the most painful headaches, characterized by recurring episodes of unilateral, periorbital pain, which is accompanied by autonomic symptoms that seem to be of both sympathetic and parasympathetic origin. The pathophysiology behind the condition is largely unknown, but increasing evidence indicate that the hypothalamus plays a pivotal role. The headache attacks come in clusters or bouts (hence the name) which last up to three months, after which the headache disappears for at least one month. 10-15% have chronic cluster headache. During attacks, the patients have cranial sympathetic hypoactivity and parasympathetic hyperactivity, whereas they have cranial parasympathetic hypoactivity during remission phase. There is an emerging hypothesis that headache attacks are elicited in a state of autonomic hypoarousability, which is also supported by the fact that most cluster attacks occur during the night, when the patients are sleeping.

The aim in this project is to study the intercept between the sleep-wake cycle, autonomic tone and the occurrence of headache attacks, by using actigraphy, heart-rate variability and pupillometry. All these methods are well validated, and frequently used in studies on sleep and autonomic function. The study design is that of a case-control model where 15 cluster headache patients will undergo pupillometry, before wearing the actigraph and heart-rate variability-monitor for two weeks, once in cluster bout and once in remission phase. The actigraphy will register nocturnal movement and sleep quality, and headache attacks will be registered by pressing a button on the actigraph. The pupillometry measures pupillary constriction and dilation in response to light, a reflex that is controlled by the autonomic nervous system. The heart-rate variability monitors fluctuations in the heart rate which reflects the sympathovagal balance of cardiac control. All participants will fill out the Pittsburgh Sleep Quality Index before and after registration. In addition, 15 healthy controls will undergo one session of the same examinations. The results of the study will give valuable insight to the pathophysiology of a condition that is very painful and has great impact on the patients' quality of life, and also add knowledge to the relation between headache, sleep and the autonomic nervous system.

详细描述

Cluster headache (CH) is a primary headache in which recurring episodes of unilateral, periorbital pain is accompanied by unilateral autonomic symptoms such as tearing, conjunctival injection, nasal congestion or rhinorrhea, miosis and ptosis. Headache attacks last from 15 to 180 minutes, and patients may have up to eight attacks each day. Most attacks occur at night between midnight and 04 a.m. Headache attacks come in recurring bouts lasting up to three months, after which the headache disappears for at least one month. 10-15% of patients have chronic cluster headache, meaning that there are no pauses between bouts. The condition has a prevalence of about 0.2% and affects men 3-4 times more often than women.

The combination of unilateral headache and autonomic symptoms makes CH an interesting disorder to study in view of headache pathophysiology. Increasing amounts of evidence points at the hypothalamus as the locus in quo for CH pathophysiology. During attacks, the autonomic symptoms seem to be caused both by a hypofunction of sympathetic activity (miosis and ptosis), and a hyperfunction of parasympathetic activity (conjunctival injection, tearing and nasal congestion). Physiological studies seem to imply that patients during bouts have an upregulated parasympathetic activity caused by activation of the trigemino-parasympathetic reflex and a downregulated sympathetic tone, while they outside of bouts have a downregulated parasympathetic tone. Studying the autonomous nervous system in cluster headache patients is difficult, as they usually have headaches only a few months during the year and the attacks are quite short lasting, but excruciating painful when they occur, leaving the patients restless and with an urge to move about. This makes it difficult to study what actually happens during the painful phase. Thus, finding new ways to study the autonomic nervous system in these patients during the various stages of their disease is very important.

In addition to autonomic dysfunction, sleep disturbances are frequent and well documented in CH patients. Sleep is often problematic in all headaches, but CH patients seem to have a high prevalence of insomnia even when compared to other headache populations. This is not merely a result of the recurring nocturnal headaches, as CH patients have significantly reduced sleep quality compared to controls even one year after last headache attack. The documentation mostly consist of studies using well validated questionnaires such as the Pittsburgh Sleep Quality Index (PSQI) or diagnostic criteria such as the DSM IV. Only one major study have assessed sleep quality in cluster headache using quantitative methods such as polysomnography. In this study, the authors found that cluster headache patients in headache bout had a reduced percentage of REM sleep, longer REM latency and fewer arousals compared to healthy controls. There was no temporal relationship between headache attacks and specific sleep stages. Sleep is the single most important trigger for attacks in cluster headache, and most attacks occur during the late night or early morning hours.

We know that the balance between sympathetic and parasympathetic tone differ between REM and NREM-sleep stages in healthy individuals, and that there is a transient decrease in sympathetic tone during the night, which is reflected in a period of reduced heart rate and blood pressure. This "dipping" coincides with the increased occurrence of cluster attacks, and fits well into the emerging theory that cluster headache attacks is elicited in a state of hypoarousability, or reduced sympathetic tone. Thus, sleep disturbances are, together with autonomic dysfunction, an integral part of CH pathophysiology, and further studies are needed to elucidate the association between sleep, autonomic dysfunction and headache attacks.

The aim of this study is to assess sleep quality and autonomic tone in CH patients inside and outside of headache bouts, compared to healthy controls. Inside of bouts, the investigators will assess how the occurrence of headache attacks are related to autonomic tone. The data will be gathered by using actigraphy, pupillometry and heart-rate variability, all well validated research tools. In addition, all participators will fill out the PSQI reporting subjective sleep quality.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
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

  • Episodic or chronic cluster headache, according to the ICHD-IIIb criteria.

排除标准

  • Cardiac arrythmia or known autonomic dysfunction.

研究组 & 干预措施

Patient

Experimental

Cluster headache patients are examined with light reflex pupillometry, two weeks actigraphy and heart-rate variability monitoring both in headache phase and remission phase.

干预措施: Actigraphy (Device)

Patient

Experimental

Cluster headache patients are examined with light reflex pupillometry, two weeks actigraphy and heart-rate variability monitoring both in headache phase and remission phase.

干预措施: Heart-rate variability monitoring (Device)

Patient

Experimental

Cluster headache patients are examined with light reflex pupillometry, two weeks actigraphy and heart-rate variability monitoring both in headache phase and remission phase.

干预措施: Pupillometry (Device)

Controls

Active Comparator

Healthy controls undergo the same examinations once: light reflex pupillometry, actigraphy and heart-rate variability monitoring.

干预措施: Actigraphy (Device)

Controls

Active Comparator

Healthy controls undergo the same examinations once: light reflex pupillometry, actigraphy and heart-rate variability monitoring.

干预措施: Heart-rate variability monitoring (Device)

Controls

Active Comparator

Healthy controls undergo the same examinations once: light reflex pupillometry, actigraphy and heart-rate variability monitoring.

干预措施: Pupillometry (Device)

结局指标

主要结局

Change in total sleep time

时间窗: Measured for two weeks during headache phase, and again four weeks after last headache attack

Average number of hours asleep per night, measured over two weeks with an actigraph

Change in pupillary average contraction velocity

时间窗: Once in the beginning of a headache phase, and once 4 weeks after last headache attack

The velocity of pupillary constriction in response to light, measured with a pupillometer, in mm/sec

Change in sleep efficiency

时间窗: Measured for two weeks during headache phase, and again four weeks after last headache attack

Average number of hours asleep per night divided by time spent in bed, measured over two weeks with an actigraph

Change in wake after sleep onset

时间窗: Measured for two weeks during headache phase, and again four weeks after last headache attack

Average number of awakenings during the sleep phase, measured over two weeks with an actigraph

Change in LF/HF ratio

时间窗: Measured for two weeks during headache phase, and again four weeks after last headache attack

The ratio of low-frequency and high-frequency fluctuations in heart rate, measured over two weeks with a heart-rate variability monitor

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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