NCT04415294

Flicker App for Minimal Hepatic Encephalopathy

Evaluating a Novel, Self-administered Device ("Flicker-App") That Measures Critical Flicker Frequency as a Test for Minimal Hepatic Encephalopathy in Cirrhosis

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 75 (estimated)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Detailed 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

Conditions

• Hepatic Encephalopathy

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Critical flicker frequency	Measure the critical flicker frequency as a screening test for hepatic encephalopathy using a portable self administered device

Timeline

• Start date: 2019-10-22
• Primary completion: 2023-05-31
• Completion: 2023-06-30
• First posted: 2020-06-04
• Last updated: 2022-01-11

Locations

1 site across 1 country: United States