RECRUITING

A Study Describing Scratch and Sleep Patterns in Patients With Primary Biliary Cholangitis (Luminaria)

Description

This study will collect information from patients with Primary Biliary Cholangitis (PBC). PBC is a progressive rare liver disease in which tubes in the liver called bile ducts are damaged. The liver damage in PBC may lead to scarring (cirrhosis). People living with PBC often face challenges like intense itching, trouble sleeping, and feeling constantly tired. These symptoms can make it hard for them to enjoy daily life and feel well overall. While itching and sleep patterns can be difficult to measure accurately based on recall and may lack precision, the main aim of this study is to use a digital health tool to assess the severity of itchiness and sleep patterns in people with PBC. The tool will take the objective measurement for people so they do not have to recall their scratch and sleep patterns. The total study duration for each patient will be about 91 days.

Conditions

Primary Biliary Cholangitis
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Related Conditions:

Primary Biliary Cholangitis

Study Overview

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Study Details

Study overview

This study will collect information from patients with Primary Biliary Cholangitis (PBC). PBC is a progressive rare liver disease in which tubes in the liver called bile ducts are damaged. The liver damage in PBC may lead to scarring (cirrhosis). People living with PBC often face challenges like intense itching, trouble sleeping, and feeling constantly tired. These symptoms can make it hard for them to enjoy daily life and feel well overall. While itching and sleep patterns can be difficult to measure accurately based on recall and may lack precision, the main aim of this study is to use a digital health tool to assess the severity of itchiness and sleep patterns in people with PBC. The tool will take the objective measurement for people so they do not have to recall their scratch and sleep patterns. The total study duration for each patient will be about 91 days.

A Multicenter Non-interventional Study for the Measurement of Scratch and Sleep Patterns Using the ADAM Sensor in Patients With Primary Biliary Cholangitis

A Study Describing Scratch and Sleep Patterns in Patients With Primary Biliary Cholangitis (Luminaria)

Condition
Primary Biliary Cholangitis
Intervention / Treatment

-

Contacts and Locations

Chandler

Arizona Liver Center, Chandler, Arizona, United States, 85224

Miami

University of Miami School of Medicine, Center for Liver Diseases, Miami, Florida, United States, 33136

Dallas

UT Southwestern Medical Center, Department of Internal Medicine, Digestive and Liver Diseases, Dallas, Texas, United States, 75390

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Aged 18 years or older at time of study enrollment.
  • * Confirmed diagnosis of PBC based on medical history and relevant clinical criteria, as determined by the study Investigator.
  • * Willingness and ability to wear the ADAM sensor during the specified time periods (7 nights across four 7-day periods).
  • * Able to read and write to ensure accurate completion of electronic PRO surveys.
  • * Able to access an internet-connected device for the completion of electronic PRO surveys.
  • * Able to provide signed, informed consent prior to collection of data.
  • * Has already been enrolled in another clinical study.
  • * Has any dermatological conditions or severe comorbidities associated with pruritus as assessed by the investigators that may confound the measurement of scratch or sleep data.
  • * Has any extrapyramidal syndrome including Parkinsonism, essential tremor, astasia/abasia, cerebellar syndrome.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Ipsen,

Ipsen Medical Director, STUDY_DIRECTOR, Ipsen

Study Record Dates

2025-12-15