Speech in Hepatic Encephalopathy (HE)

Completed

• Conditions: Hepatic Encephalopathy
• Interventions: Behavioral: Home Recordings; Behavioral: In-patient Recordings; Behavioral: Same-Day Study Visit - Regular Appointment; Behavioral: Same-Day Study Visit - Procedure; Behavioral: Phone Call Follow-up Visits

• Registration Number: NCT05425316
• Lead Sponsor: University of Michigan

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-05
• Study First Submitted: 2022-05-14
• Study First Submitted QC: 2022-06-15
• Study First Posted: 2022-06-21
• Status Verified: 2024-07
• Primary Completion: 2024-07-24
• Study Completion: 2024-07-24
• Last Update Submitted: 2024-07-24
• Last Update Posted: 2024-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 251

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with Cirrhosis	Same-Day Study Visit - Regular Appointment	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.
Patients without Cirrhosis	Same-Day Study Visit - Regular Appointment	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.
Patients with Cirrhosis	Home Recordings	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.
Patients with Cirrhosis	In-patient Recordings	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.
Patients without Cirrhosis	Home Recordings	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.
Patients with Cirrhosis	Same-Day Study Visit - Procedure	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.
Patients with Cirrhosis	Phone Call Follow-up Visits	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.

Primary Outcome Measures

Name	Time	Method
Change in Psychometric Hepatic Encephalopathy Score (PHES) from Baseline to 6 Months	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.
Change in Psychometric Hepatic Encephalopathy Score (PHES) from Baseline to 12 Months	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.
Speech Assessments	12 Months	Recorded speech tasks comprising 3 sections: paragraph reading test, picture description test, and animal naming test.
Time to Overt Hepatic Encephalopathy (HE)	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.

Trial Locations

Locations (1)

University of Michigan Hepatology and Transplant Clinic; 🇺🇸 Ann Arbor, Michigan, United States