Speech in Hepatic Encephalopathy (HE)

NCT ID: NCT05425316

Last Updated: 2024-07-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 251 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-10-05
• Study Completion Date: 2024-07-24

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.

Conditions

Hepatic Encephalopathy

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Home Recordings

Intervention Type: BEHAVIORAL

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

Intervention Type: BEHAVIORAL

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

Intervention Type: BEHAVIORAL

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

Intervention Type: BEHAVIORAL

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

Intervention Type: BEHAVIORAL

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.

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.

Home Recordings

Intervention Type: BEHAVIORAL

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.

Same-Day Study Visit - Regular Appointment

Intervention Type: BEHAVIORAL

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.

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Cirrhosis, as diagnosed by imaging, elastography, biopsy, or decompensation
• Able to provide informed consent in English

• Able to provide informed consent in English
• Fibroscan with stiffness <7 kPa

Exclusion Criteria

• Neurodegenerative disorder (other than hepatic encephalopathy) including Alzheimer's disease and dementia
• Prior stroke or Transischemic Attack (TIA)
• English not primary language for communication

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Winterlight Labs

INDUSTRY

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Patricia Bloom

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Patricia Bloom, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan Hepatology and Transplant Clinic

Ann Arbor, Michigan, United States

Countries

United States

Other Identifiers

HUM00191626

Identifier Type: -

Identifier Source: org_study_id