Analysis of Acoustic, Lexical, and Syntactic Speech Features in Hepatic Encephalopathy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 251
- 试验地点
- 2
- 主要终点
- Change in Psychometric Hepatic Encephalopathy Score (PHES) from Baseline to 6 Months
研究概览
简要总结
This is an observational study that will test the clinical significance of speech features in patients with cirrhosis. It aims to assess if speech is associated with cognitive function at baseline, if speech predicts changes in cognition, and if speech predicts future events of hepatic encephalopathy (cirrhosis-related confusion), as well as to assess the dynamics of speech over time, especially with episodes of overt hepatic encephalopathy (OHE) and treatment interventions.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •for Patients with Cirrhosis:
- •Cirrhosis, as diagnosed by imaging, elastography, biopsy, or decompensation
- •Able to provide informed consent in English
排除标准
- •for Patients with Cirrhosis:
- •Neurodegenerative disorder (other than hepatic encephalopathy) including Alzheimer's disease and dementia
- •Prior stroke or Transischemic Attack (TIA)
- •English not primary language for communication
- •Inclusion Criteria for Patients without Cirrhosis:
- •Able to provide informed consent in English
- •Fibroscan with stiffness <7 kPa
- •Exclusion Criteria for Patients without Cirrhosis:
- •Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) >5 times the upper limit of normal in the last year
- •History of cirrhosis by imaging or histology or clinical decompensation
- •Neurodegenerative disorder (other than hepatic encephalopathy) including Alzheimer's disease and dementia
- •Prior stroke or TIA
结局指标
主要结局
Change in Psychometric Hepatic Encephalopathy Score (PHES) from Baseline to 6 Months
时间窗: 6 Months
A well-validated pen-and-paper neurocognitive assessment tool to identify minimal Hepatic Encephalopathy (HE). Scores range from -15 to +5; values farther from 0 (normalized average) represent more significant deviation from the norm. Positive scores indicate better performance.
Change in Psychometric Hepatic Encephalopathy Score (PHES) from Baseline to 12 Months
时间窗: 12 Months
A well-validated pen-and-paper neurocognitive assessment tool to identify minimal Hepatic Encephalopathy (HE). Scores range from -15 to +5; values farther from 0 (normalized average) represent more significant deviation from the norm. Positive scores indicate better performance.
Speech Assessments
时间窗: 12 Months
Recorded speech tasks comprising 3 sections: paragraph reading test, picture description test, and animal naming test.
Time to Overt Hepatic Encephalopathy (HE)
时间窗: 12 Months
Patient-reported HE episodes and HE episodes resulting in patient admission to University of Michigan hospital. Information collected includes: Date of symptom onset, duration of HE episode, and changes to medications.
次要结局
未报告次要终点
研究者
Patricia Bloom
Assistant Professor
University of Michigan