AVASNA : Variability of the Autonomic Nervous System (ANS) During Cluster Headache (CH).
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Low Frequency/High Frequency (LF/HF) ratio at the onset of the first night seizure
研究概览
简要总结
Cluster Headache (CH) is associated with ipsilateral vegetative signs, related to parasympathetic system hyperactivity and/or signs of sympathetic hypoactivity. The precise mechanism of Cluster Headache (CH) is still unknown. The question is whether these dysautonomic disorders are simply secondary to the Cluster Headache (CH) process or whether they are the triggering factor.
详细描述
This study cares about the evolution of the Autonomic Nervous System (ANS) in Cluster Headache (CH) seizures. Patients will be offered Holter ECG to study the temporal relationships between changes in Autonomic Nervous System (ANS) activity during Headache (CH) seizures and changes in Autonomic Nervous System (ANS) activity before and after seizure treatment, using heart rate variability measurement.
The hypothesis is that there would be an initial temporary sympathetic activation, followed quickly by parasympathetic hyperactivation and a return to a state of equilibrium.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •Patient over 18 years of age
- •Affiliated or entitled to a Social Security scheme
- •Resident in the territories of the hospital grouping of Loire territory (located less than 50 km away)
- •Whose diagnosis of episodic or chronic Cluster Headache (CH) has been confirmed according to International Classification of Headache Disorders (ICHD)- 3 criteria
- •With a regular sinus rhythm and heart rate
排除标准
- •Conditions contraindicating the use of injectable sumatriptan
- •Conditions likely to affect the Autonomic Nervous System (ANS): dysautonomic sensory neuropathies, sleep apnea syndrome, etc.
- •Cognitive or language disorders that may interfere with pain assessment and seizure follow-up.
- •Patients taking treatments that may modify the Autonomic Nervous System (ANS): catecholamine (adrenaline, noradrenaline, dopamine), B-stimulants (isoprenaline, dobutamine, dopexamine, salbutamol, terbutaline, fenoterol, orciprenaline, clenbuterol, salmeterol, formoterol), B-blockers, alpha-stimulants (midodrine, alpha-methyl-dopa, clonidine, rilmenidine, moxonidine), alpha-blockers (phentolamine, prazosin, urapidil), amphetamine, tyramine, ephedrine, selegiline, cocaine, imipramine.
- •Impossibility to submit to the medical follow-up of the program for geographical, social or psychological reasons.
- •Patient deprived of liberty or under guardianship.
- •Patient with preventive background treatment of Cluster Headache (CH).
结局指标
主要结局
Low Frequency/High Frequency (LF/HF) ratio at the onset of the first night seizure
时间窗: Day: 7
Comparison of the Low Frequency/High Frequency (LF/HF) ratio at the onset of the first night seizure during the basal period, pre-seizure, seizure and after the seizure.
次要结局
- Low Frequency/High Frequency (LF/HF) ratio at the onset of the first daytime seizure(Day: 7)
- Low Frequency during daytime and night seizure(Day: 7)
- High Frequency (HF) during daytime and night seizure(Day: 7)
- Correlation between several parameters(Day: 7)