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NCT04415294 Clinical Trial

Flicker App for Minimal Hepatic Encephalopathy

Hepatic Encephalopathy Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04415294
Other study ID # STUDY00004521
Secondary ID R21DK117431
Status Recruiting
Phase
First received
Last updated
Start date October 22, 2019
Est. completion date June 30, 2023

Study information
Verified date January 2022
Source University of Washington
Contact Michael Yacoub
Phone 2067443402
Email yacoum@washington.medicine.edu
Is FDA regulated No
Health authority
Study type Observational

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

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

Recruitment information / eligibility
Status Recruiting
Enrollment 75
Est. completion date June 30, 2023
Est. primary completion date May 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - Cirrhosis (standard criteria) - Chronic liver disease Exclusion Criteria: - Grade III or IV hepatic encephalopathy - Mini-mental state examination score =25 (suggestive of dementia) - alcohol or illicit drug use within 3 months - current use of benzodiazepines - antiepileptics or psychotropic drugs - color blindness - severe vision impairment (blindness, macular degeneration).

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Critical flicker frequency
Measure the critical flicker frequency as a screening test for hepatic encephalopathy using a portable self administered device

Locations
Country Name City State
United States University of Washington Medical Center Seattle Washington

Sponsors (2)
Lead Sponsor Collaborator
University of Washington National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary CFF Agreement Level of agreement between Flicker App CFF and gold-standard device 1 day
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