Hepatic EncephalopathyNCT05425316
Speech in Hepatic Encephalopathy (HE)
An observational study of Hepatic Encephalopathy, run by University of Michigan at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatic Encephalopathy
- What is being tested?
- Home Recordings, In-patient Recordings and Same-Day Study Visit - Regular Appointment
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 251 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Oct 2021to 24 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study population consists of adult outpatients who are evaluated at the University of Michigan Hepatology Clinic.
Who may be able to join
- Cirrhosis, as diagnosed by imaging, elastography, biopsy, or decompensation
- Able to provide informed consent in English
- Able to provide informed consent in English
- Fibroscan with stiffness <7 kPa
Who cannot join
- Neurodegenerative disorder (other than hepatic encephalopathy) including Alzheimer's disease and dementia
- Prior stroke or Transischemic Attack (TIA)
- English not primary language for communication
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Hepatology and Transplant Clinic
Ann Arbor, Michigan, 48109
About this study
Official title: Analysis of Acoustic, Lexical, and Syntactic Speech Features in Hepatic Encephalopathy
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.
- Conditions
- Hepatic Encephalopathy
- Being tested
- Home Recordings, In-patient Recordings, Same-Day Study Visit - Regular Appointment, Same-Day Study Visit - Procedure, Phone Call Follow-up Visits
- Medical subject headings
- Hepatic Encephalopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home RecordingsBehavioural
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 RecordingsBehavioural
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 AppointmentBehavioural
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 - ProcedureBehavioural
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 VisitsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Cirrhosis | 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. Receives: 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 | |
| Patients without Cirrhosis | 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. Receives: Behavioral: Home Recordings; Behavioral: Same-Day Study Visit - Regular Appointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Psychometric Hepatic Encephalopathy Score (PHES) from Baseline to 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.
Measured: 6 Months
Change in Psychometric Hepatic Encephalopathy Score (PHES) from Baseline to 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.
Measured: 12 Months
Speech Assessments
Recorded speech tasks comprising 3 sections: paragraph reading test, picture description test, and animal naming test.
Measured: 12 Months
Time to Overt Hepatic Encephalopathy (HE)
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.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start5 Oct 2021
- Primary completion24 Jul 2024
- Study completion24 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic EncephalopathyStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 251 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Winterlight Labs
- Responsible party
- Principal investigator, Patricia Bloom, University of Michigan
- Investigators
- Patricia Bloom, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05425316
- Sponsor's protocol ID
- HUM00191626
- Status last verified
- Jul 2024
- First submitted
- 14 May 2022
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Acoustic, Lexical, and Syntactic Speech Features in Hepatic Encephalopathy
- ClinicalTrials.gov ID
- NCT05425316
- Acronym / sponsor ID
- HUM00191626
- Conditions
- Hepatic Encephalopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 251 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Winterlight Labs
- Study start
- 5 Oct 2021 (actual)
- Primary completion
- 24 Jul 2024 (actual)
- Study completion
- 24 Jul 2024 (actual)
- First posted
- 21 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with Cirrhosis | – | 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 VisitsThis 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 | – | Behavioral: Home Recordings, Behavioral: Same-Day Study Visit - Regular AppointmentThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study population consists of adult outpatients who are evaluated at the University of Michigan Hepatology Clinic.
Key inclusion criteria (4 listed)
- Cirrhosis, as diagnosed by imaging, elastography, biopsy, or decompensation
- Able to provide informed consent in English
- Able to provide informed consent in English
- Fibroscan with stiffness <7 kPa
Key exclusion criteria (7 listed)
- Neurodegenerative disorder (other than hepatic encephalopathy) including Alzheimer's disease and dementia
- Prior stroke or Transischemic Attack (TIA)
- English not primary language for communication
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home RecordingsIf 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. | Behavioural | Patients with Cirrhosis, Patients without Cirrhosis |
| In-patient RecordingsIf 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. | Behavioural | Patients with Cirrhosis |
| Same-Day Study Visit - Regular AppointmentStaff 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. | Behavioural | Patients with Cirrhosis, Patients without Cirrhosis |
| Same-Day Study Visit - ProcedureStaff 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. | Behavioural | Patients with Cirrhosis |
| Phone Call Follow-up VisitsNon-physician study staff will call the patients every 3 months and, using a phone script, will ask them survey questions about their hepatic health. | Behavioural | Patients with Cirrhosis |
Primary outcome
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.
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.
Speech Assessments
Time frame: 12 Months
Recorded speech tasks comprising 3 sections: paragraph reading test, picture description test, and animal naming test.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patricia Bloom, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatic Encephalopathy, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Psychometric Hepatic Encephalopathy Score (PHES) from Baseline to 6 Months (time frame: 6 Months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026; AzTrials last refreshed its copy on 27 Oct 2026.