Contextuele Analyse, Fysiologische Metingen en Machinaal Leren Voor Migraine en Clusterhoofdpijn (COPIMAC Studie)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Galvanic Skin Response changes
研究概览
简要总结
This is an observational, longitudinal cohort pilot study measuring physiological signals through wearable sensors combined with machine learning algorithms to detect behaviour, stress and headaches in patients with migraine and cluster headache.
详细描述
Migraine and cluster headache are among the most disabling headache conditions in humans. Both conditions have different phases such as the prodromal/premonitory phase, the aura phase, the headache phase and the postdromal phase. This pilot study examines the potential of wearable sensors combined with machine learning algorithms to investigate the biological changes over time in both conditions. Behaviour such as movement, sleep and activity will be monitored. Stress levels will be estimated through the wearable data combined with input from the patients. Participants will use a wearable device around the wrist and self-developed headache application for 21 days.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •migraine or cluster headache diagnosis based on ICHD 3 criteria
- •at least 2 attacks each month
- •onset of headache syndrome before the age of 50
- •if multiple headache syndromes coexist: attacks are clearly distinguishable
- •participant has smartphone that he/she wants to apply for this research
排除标准
- •chronic migraine patients
- •history of alcohol or illicit drug abuse
- •significant medical comorbidity deemed by the investigator to interfere with the study
- •use of betablockers
- •participating in other academic or commercial trials
结局指标
主要结局
Galvanic Skin Response changes
时间窗: 21 days
Changes in GSR through the different phases of the headache attacks
次要结局
- Activity ratio(21 days)
- Skin temperature(21 days)