Skip to main content
OpenTrials
Completed

NCT Number: NCT05425316

Speech in Hepatic Encephalopathy (HE)

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hepatic Encephalopathy Brain Diseases Brain Diseases, Metabolic Central Nervous System Diseases Digestive System Diseases Hepatic Insufficiency Liver Diseases Liver Failure Metabolic Diseases Nervous System Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Michigan Hepatology and Transplant Clinic

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Home Recordings

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

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

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

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

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.

Primary outcomes

  1. Change in Psychometric Hepatic Encephalopathy Score (PHES) from Baseline to 6 Months

    Time frame: 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.

  2. Change in Psychometric Hepatic Encephalopathy Score (PHES) from Baseline to 12 Months

    Time frame: 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.

  3. Speech Assessments

    Time frame: 12 Months

    Recorded speech tasks comprising 3 sections: paragraph reading test, picture description test, and animal naming test.

  4. Time to Overt Hepatic Encephalopathy (HE)

    Time frame: 12 Months

    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.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • Winterlight Labs

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jun 21, 2022
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.