NCT05425316

Speech in Hepatic Encephalopathy (HE)

Analysis of Acoustic, Lexical, and Syntactic Speech Features in Hepatic Encephalopathy

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 251 (actual)
• Sponsor: University of Michigan · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hepatic Encephalopathy

Interventions

Type	Name	Description
BEHAVIORAL	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.
BEHAVIORAL	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.
BEHAVIORAL	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.
BEHAVIORAL	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.
BEHAVIORAL	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.

Timeline

• Start date: 2021-10-05
• Primary completion: 2024-07-24
• Completion: 2024-07-24
• First posted: 2022-06-21
• Last updated: 2024-07-26

Locations

1 site across 1 country: United States