Evaluating a Novel, Self-administered Device ("Flicker-App") That Measures Critical Flicker Frequency as a Test for Minimal Hepatic Encephalopathy in Cirrhosis
试验速览
- 阶段
- 不适用
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- CFF Agreement
研究概览
简要总结
There is a great unmet clinical need for improved screening for MHE in patients with cirrhosis. We will demonstrate that the Flicker-App can be used in clinic as well as at home by patients with cirrhosis to measure CFF, a proven screening test for MHE. We will optimize the protocol, software, and hardware of the Flicker-App to create a product appropriate for production and distribution to patients
详细描述
SA 1. Determine whether cirrhotic patients (n=75) can self-administer the Flicker-App in clinic supervised by a research assistant and calculate the level of agreement between the CFF determined by the Flicker-App, the CFF determined by the "gold-standard" FFS device, and the test scores on the EncephalApp Stroop test.
SA 2. Determine whether cirrhotic patients (n=75) can self-administer the Flicker-App at home, including daily measurements over 1 week and weekly measurements over 6 weeks, and calculate the adherence to this protocol and the variability of these CFF measurements.
SA3. Make any necessary software or hardware adjustments to the Flicker-App to facilitate and simplify its self-administration by patients based on structured interview-questionnaires with the study participants and with clinical Gastroenterologists/Hepatologists
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cirrhosis (standard criteria)
- •Chronic liver disease
排除标准
- •Grade III or IV hepatic encephalopathy
- •Mini-mental state examination score ≤25 (suggestive of dementia)
- •alcohol or illicit drug use within 3 months
- •current use of benzodiazepines
- •antiepileptics or psychotropic drugs
- •color blindness
- •severe vision impairment (blindness, macular degeneration).
结局指标
主要结局
CFF Agreement
时间窗: 1 day
Level of agreement between Flicker App CFF and gold-standard device
次要结局
未报告次要终点
研究者
George Ioannou
Professor, School of Medicine
University of Washington