Validation of Readiband™ Actigraph and Associated Sleep/Wake Classification Algorithms in Predicting Cancer Related Fatigue and Diseases Progression in High Grade Glioma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Correlation between sleep patterns and disease progression/recurrence
研究概览
简要总结
This pilot study will assess feasibility and to obtain initial estimates of efficacy of Sleep Activity and Task Effectiveness (SAFTE) model, which can accurately estimate the impact of scheduling factors and sleep history on both safety and productivity. The SAFTE model will be used to asses cancer-related fatigue and study potential associations of change in sleep patterns to tumor recurrence in patients with high grade glioma. Data will be collected using the Readiband™ Sleep Tracker (https://www.fatiguescience.com/sleep-science-technology/). The Readiband device captures high-resolution sleep data, validated against the clinical gold standard of polysomnography with 92% accuracy. Sleep data is transmitted to the cloud automatically for SAFTE Fatigue Model analysis. We will correlate clinical progression data obtained from the patient's electronic medical record with SAFTE data.
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
- 22 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Correlation between sleep patterns and disease progression/recurrence
时间窗: Participant enrollment to 12 months (or until tumor progression)
An estimate of correlation between sleep patterns in the brain tumor patient population and disease progression or recurrence compared to those of the general population.
次要结局
- Correlation between SAFTE fatigue predictions and self-reported fatigue levels(Participant enrollment to 12 months (or until tumor progression))
- Sleep pattern differences between healthy controls and brain tumor patients(Participant enrollment to 12 months (or until tumor progression))
- Correlation between fatigue and sleep patterns and treatment tolerance/success(Participant enrollment to 12 months (or until tumor progression))
- Change in Sleep, Activity, Fatigue, and Task Effectiveness (SAFTE) score(Participant enrollment to 12 months (or until tumor progression))