Flicker App for Minimal Hepatic Encephalopathy

Status Recruiting

Clinical Trial Summary

There is a great unmet clinical need for improved screening for MHE in patients with cirrhosis. We will demonstrate that the Flicker-App can be used in clinic as well as at home by patients with cirrhosis to measure CFF, a proven screening test for MHE. We will optimize the protocol, software, and hardware of the Flicker-App to create a product appropriate for production and distribution to patients

Clinical Trial Description

SA 1. Determine whether cirrhotic patients (n=75) can self-administer the Flicker-App in clinic supervised by a research assistant and calculate the level of agreement between the CFF determined by the Flicker-App, the CFF determined by the "gold-standard" FFS device, and the test scores on the EncephalApp Stroop test. SA 2. Determine whether cirrhotic patients (n=75) can self-administer the Flicker-App at home, including daily measurements over 1 week and weekly measurements over 6 weeks, and calculate the adherence to this protocol and the variability of these CFF measurements. SA3. Make any necessary software or hardware adjustments to the Flicker-App to facilitate and simplify its self-administration by patients based on structured interview-questionnaires with the study participants and with clinical Gastroenterologists/Hepatologists ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04415294
Study type	Observational
Source	University of Washington
Contact	Michael Yacoub
Phone	2067443402
Email	yacoum@washington.medicine.edu
Status	Recruiting
Phase
Start date	October 22, 2019
Completion date	June 30, 2023

View Details

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