Speech in Hepatic Encephalopathy (HE) (NCT05425316) | Clinical Trial Compass
CompletedNot Applicable
Speech in Hepatic Encephalopathy (HE)
United States251 participantsStarted 2021-10-05
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Psychometric Hepatic Encephalopathy Score (PHES) from Baseline to 6 Months
Timeframe: 6 Months
2
Change in Psychometric Hepatic Encephalopathy Score (PHES) from Baseline to 12 Months