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| Name | Class |
|---|---|
| Winterlight Labs | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Home Recordings | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 12 Months |
| Speech Assessments | Recorded speech tasks comprising 3 sections: paragraph reading test, picture description test, and animal naming test. | 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. | 12 Months |
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Inclusion Criteria for Patients with Cirrhosis:
Exclusion Criteria for Patients with Cirrhosis:
Inclusion Criteria for Patients without Cirrhosis:
Exclusion Criteria for Patients without Cirrhosis:
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Study population consists of adult outpatients who are evaluated at the University of Michigan Hepatology Clinic.
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| Name | Affiliation | Role |
|---|---|---|
| Patricia Bloom, MD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan Hepatology and Transplant Clinic | Ann Arbor | Michigan | 48109 | United States |
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| ID | Term |
|---|---|
| D006501 | Hepatic Encephalopathy |
| ID | Term |
|---|---|
| D017093 | Liver Failure |
| D048550 | Hepatic Insufficiency |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| In-patient Recordings | Behavioral | 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. |
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| Same-Day Study Visit - Regular Appointment | Behavioral | 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. |
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| Same-Day Study Visit - Procedure | Behavioral | 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. |
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| Phone Call Follow-up Visits | Behavioral | 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. |
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| D001928 |
| Brain Diseases, Metabolic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |