A Prospective Feasibility Study Evaluating the Use of Wearable Devices to Predict and Track Clinical Outcomes in Chronic Migraine
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Mayo Clinic
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Percentage accuracy of fit with AUC of the ROC (receiver operating characteristics) curve (%) for headache tracking.
研究概览
简要总结
The purpose of this research is to determine if data from smart devices, including heart rate and movement during sleep and wake times, will be able to track headaches and predict recurrence and exacerbations (make worse). This use of this information may in the future allow patients earlier and more effective treatments if these devices can help predict when the headaches may occur.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- 否
入选标准
- •Age 18 years and older (no upper age limit defined)
- •History of chronic migraine as defined by the International Headache Society's International Classification of Headache Disorders (3rd edition).
- •Response to current preventative therapy with ≥ 50% improvement in the frequency of headache days when compared to baseline
- •4 to 14 average number of total headache days per month during peak efficacy of preventative therapy
- •Ability to understand study procedures and to comply with them for the entire length of the study and use study devices as outlined in protocol.
- •Patient agrees to maintain a daily electronic headache diary.
- •Proficient in the use of electronic devices including Apple HomeKit and Apple Watch. - Subjects owns an iPhone with iOS 16 or later operating system installed on iPhone. Apple watch series 8 with watch OS6 or later will be provided by the study.
排除标准
- •Chronic daily headache with no periods of headache freedom.
- •≥ 15 average number of headaches days per month during peak efficacy of preventative treatment.
- •Medication overuse headache as defined by the International Headache Society's International Classification of Headache Disorders (3rd edition).
- •Daily opioid use for > 3 months (e.g., hydrocodone, oxycodone, fentanyl patch) or other daily analgesic use for chronic pain disorders (e.g., NSAIDS or acetaminophen).
- •Inability or unwillingness of individual or legal guardian/representative to give written informed consent.
研究组 & 干预措施
Custom Phone eHealth Application
Subjects diagnosed with migraine headaches and have had a positive response to prevention treatments for migraine, will wear an Apple Watch whenever possible (including during sleep) and complete application questionnaires on the eHealth application daily.
干预措施: eHealth Application (Other)
结局指标
主要结局
Percentage accuracy of fit with AUC of the ROC (receiver operating characteristics) curve (%) for headache tracking.
时间窗: 6 months
Percentage accuracy of fit with AUC of the ROC curve for factors from data collected from custom phone app integrated with smart devices to track headache frequency and severity.
次要结局
- Percentage accuracy of fit with AUC of the ROC curve (%) for headache forecasting.(6 months)
- Correlation coefficients of wearable sensor data to headache frequency and severity.(6 months)
- uMARS app quality mean score(6 months)
研究者
Narayan R. Kissoon
Principal Investigator
Mayo Clinic