Speech in Hepatic Encephalopathy (HE)
Analysis of Acoustic, Lexical, and Syntactic Speech Features in Hepatic Encephalopathy
1 other identifier
observational
251
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2021
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 5, 2021
CompletedFirst Submitted
Initial submission to the registry
May 14, 2022
CompletedFirst Posted
Study publicly available on registry
June 21, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 24, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
July 24, 2024
CompletedJuly 26, 2024
July 1, 2024
2.8 years
May 14, 2022
July 24, 2024
Conditions
Outcome Measures
Primary Outcomes (4)
Change in Psychometric Hepatic Encephalopathy Score (PHES) from Baseline to 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.
6 Months
Change in Psychometric Hepatic Encephalopathy Score (PHES) from Baseline to 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.
12 Months
Speech Assessments
Recorded speech tasks comprising 3 sections: paragraph reading test, picture description test, and animal naming test.
12 Months
Time to Overt Hepatic Encephalopathy (HE)
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.
12 Months
Study Arms (2)
Patients with Cirrhosis
This group will be composed of 200 patients with cirrhosis. Patients will be enrolled regardless of compensated vs. decompensated status, prior history of HE, Model for End Stage Liver Disease (MELD), and cirrhosis etiology.
Patients without Cirrhosis
This group will be composed of 50 patients without cirrhosis to act as controls. They will have been found on Fibroscan to not have significant fibrosis.
Interventions
If patients are willing to download the Winterlight application to their personal iOS devices this will be done at study visit 1. The application will send a notification to the patient once per month, requesting that they perform a paragraph reading task, a picture description task, and an animal naming task.
If patients are admitted to UM hospital for suspected or confirmed OHE, with patient assent, physician study staff will assist the patient in recording a paragraph reading task, a picture description task, and an animal naming task.
Staff will call patients in anticipation of in-person regular visits to set up a same-day study visit. Patients will record the three speech tasks at this time.
Staff will call patients in anticipation of in-person procedure visits to set up a same-day study visit, prior to procedure if sedation is planned. Patients will record the three speech tasks at this time.
Non-physician study staff will call the patients every 3 months and, using a phone script, will ask them survey questions about their hepatic health.
Eligibility Criteria
Study population consists of adult outpatients who are evaluated at the University of Michigan Hepatology Clinic.
You may qualify if:
- Cirrhosis, as diagnosed by imaging, elastography, biopsy, or decompensation
- Able to provide informed consent in English
You may not qualify if:
- Neurodegenerative disorder (other than hepatic encephalopathy) including Alzheimer's disease and dementia
- Prior stroke or Transischemic Attack (TIA)
- English not primary language for communication
- Able to provide informed consent in English
- Fibroscan with stiffness \<7 kPa
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Michiganlead
- Winterlight Labscollaborator
Study Sites (1)
University of Michigan Hepatology and Transplant Clinic
Ann Arbor, Michigan, 48109, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Patricia Bloom, MD
University of Michigan
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
May 14, 2022
First Posted
June 21, 2022
Study Start
October 5, 2021
Primary Completion
July 24, 2024
Study Completion
July 24, 2024
Last Updated
July 26, 2024
Record last verified: 2024-07