MedTrace Logo

Speech in Hepatic Encephalopathy (HE)

NCT05425316 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 251

Last updated 2026-05-11

No results posted yet for this study

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

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.

Sponsors & Collaborators

Principal Investigators

  • Patricia Bloom, MD · University of Michigan

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-05
Primary Completion
2024-07-24
Completion
2024-07-24

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05425316 on ClinicalTrials.gov