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Speech in Hepatic Encephalopathy (HE)
Sponsor: University of Michigan
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.
Official title: Analysis of Acoustic, Lexical, and Syntactic Speech Features in Hepatic Encephalopathy
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
251
Start Date
2021-10-05
Completion Date
2024-07-24
Last Updated
2026-05-11
Healthy Volunteers
No
Conditions
Interventions
Home Recordings
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.
In-patient Recordings
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.
Same-Day Study Visit - Regular Appointment
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.
Same-Day Study Visit - Procedure
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.
Phone Call Follow-up Visits
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.
Locations (1)
University of Michigan Hepatology and Transplant Clinic
Ann Arbor, Michigan, United States