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NCT05425316 · ClinicalTrials.gov registry record
Speech in Hepatic Encephalopathy (HE)
A clinical trial, sponsored by University of Michigan.
- Completed
- Registry status
- 251
- Enrollment target
NCT05425316: Completed study, sponsored by University of Michigan.
NCT05425316 is a clinical trial that has completed, run by University of Michigan. The registered enrollment target is 251 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05425316 has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- 251 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- 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
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 251 participants |
| Start Date | 2021-10-05 |
| Est. Completion | 2024-07-24 |
What the finished NCT05425316 record still lists
NCT05425316 is an observational study that tracks outcomes without assigning an intervention. The registered 251 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 5 interventions - of which Home Recordings is the first listed.
NCT05425316 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05425316 about?
NCT05425316 is a clinical study titled "Speech in Hepatic Encephalopathy (HE)". 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 encephalopath...
What is the current status of trial NCT05425316?
This trial is currently completed. The enrollment target is 251 participants. The study started on 2021-10-05. Estimated completion is 2024-07-24.
What interventions are being tested in trial NCT05425316?
The interventions under investigation include: 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 (BEHAVIORAL).
Who is sponsoring clinical trial NCT05425316?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
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