Speech in Hepatic Encephalopathy (HE)

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Brief Title

Speech in Hepatic Encephalopathy (HE)

Official Title

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

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.
    



Study Type

Observational


Primary Outcome

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


Condition

Hepatic Encephalopathy

Intervention

Home Recordings

Study Arms / Comparison 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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Behavioral

Estimated Enrollment

250

Start Date

October 5, 2021

Completion Date

December 2024

Primary Completion Date

December 2024

Eligibility 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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Patricia Bloom, MD, 734-647-9252, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT05425316

Organization ID

HUM00191626


Responsible Party

Principal Investigator

Study Sponsor

University of Michigan

Collaborators

 Winterlight Labs

Study Sponsor

Patricia Bloom, MD, Principal Investigator, University of Michigan


Verification Date

June 2022