Speech in Hepatic Encephalopathy (HE)

CompletedOBSERVATIONAL
Enrollment

251

Participants

Timeline

Start Date

October 5, 2021

Primary Completion Date

July 24, 2024

Study Completion Date

July 24, 2024

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.

Trial Locations (1)

48109

University of Michigan Hepatology and Transplant Clinic, Ann Arbor

All Listed Sponsors
collaborator

Winterlight Labs

INDUSTRY

lead

University of Michigan

OTHER

NCT05425316 - Speech in Hepatic Encephalopathy (HE) | Biotech Hunter | Biotech Hunter