Status:
COMPLETED
Speech in Hepatic Encephalopathy (HE)
Lead Sponsor:
University of Michigan
Collaborating Sponsors:
Winterlight Labs
Conditions:
Hepatic Encephalopathy
Eligibility:
All Genders
18+ years
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 5 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 24 2024
Estimated Enrollment :
251 Patients enrolled
Trial Details
Trial ID
NCT05425316
Start Date
October 5 2021
End Date
July 24 2024
Last Update
July 26 2024
Active Locations (1)
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1
University of Michigan Hepatology and Transplant Clinic
Ann Arbor, Michigan, United States, 48109