Recruiting

Flicker App

Sponsor:

University of Washington

Code:

NCT04415294

Conditions

Hepatic Encephalopathy

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Critical flicker frequency

Study Details

Brief 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

Conditions

Hepatic Encephalopathy

Study ID

NCT04415294

Start date

Oct 22, 2019

Status verified date

Jan, 2022

Completion date

Jun 30, 2023

Anticipated

Primary completion date

May 31, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

75 participants

Anticipated

Interventions and Outcome Measures

Interventions

Critical flicker frequency

Measure the critical flicker frequency as a screening test for hepatic encephalopathy using a portable self administered device

Primary outcome measure

  • CFF Agreement [ Time Frame: 1 day ]

Central Contacts and Locations

Central contacts

Michael Yacoub

2067443402yacoum@washington.medicine.edu

Locations

University of Washington Medical Center

Recruiting

Seattle, Washington, United States, 98104

Contacts

Michael Yacoub

206-744-3402yacoum@medicine.washington.edu

More Information

Sponsor

University of Washington

Last update posted

Jan 11, 2022

Last verified

Jan, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Washington on 2022-01-11.