Speech in Hepatic Encephalopathy (HE)

University of Michigan

Status: Completed

Conditions: Hepatic Encephalopathy

Treatments: Behavioral: Home Recordings; Behavioral: In-patient Recordings; Behavioral: Phone Call Follow-up Visits; Behavioral: Same-Day Study Visit - Regular Appointment; Behavioral: Same-Day Study Visit - Procedure

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05425316

HUM00191626

Details and patient eligibility

About

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.

Enrollment: 251 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria for Patients with Cirrhosis:

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

Exclusion Criteria for Patients with Cirrhosis:

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

Inclusion Criteria for Patients without Cirrhosis:

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

Exclusion Criteria for Patients without Cirrhosis:

• 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

Trial design

251 participants in 2 patient groups

Patients with Cirrhosis

Description:

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.

Treatment:

Behavioral: Same-Day Study Visit - Procedure

Behavioral: Same-Day Study Visit - Regular Appointment

Behavioral: Phone Call Follow-up Visits

Behavioral: In-patient Recordings

Behavioral: Home Recordings

Patients without Cirrhosis

Description:

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.

Treatment:

Behavioral: Same-Day Study Visit - Regular Appointment

Behavioral: Home Recordings