Speech in Hepatic Encephalopathy (HE)

Hepatic Encephalopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05425316
• Other study ID #: HUM00191626
• Status: Active, not recruiting
• Start date: October 5, 2021
• Est. completion date: August 2024

Study information

• Verified date: July 2023
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 251
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Diseases
• Hepatic Encephalopathy

Intervention

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.
• 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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	University of Michigan Hepatology and Transplant Clinic	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	Winterlight Labs

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Psychometric Hepatic Encephalopathy Score (PHES) from Baseline to 6 Months	A well-validated pen-and-paper neurocognitive assessment tool to identify minimal Hepatic Encephalopathy (HE). Scores range from -15 to +5; values farther from 0 (normalized average) represent more significant deviation from the norm. Positive scores indicate better performance.	6 Months
Primary	Change in Psychometric Hepatic Encephalopathy Score (PHES) from Baseline to 12 Months	A well-validated pen-and-paper neurocognitive assessment tool to identify minimal Hepatic Encephalopathy (HE). Scores range from -15 to +5; values farther from 0 (normalized average) represent more significant deviation from the norm. Positive scores indicate better performance.	12 Months
Primary	Speech Assessments	Recorded speech tasks comprising 3 sections: paragraph reading test, picture description test, and animal naming test.	12 Months
Primary	Time to Overt Hepatic Encephalopathy (HE)	Patient-reported HE episodes and HE episodes resulting in patient admission to University of Michigan hospital. Information collected includes: Date of symptom onset, duration of HE episode, and changes to medications.	12 Months