NCT07049887

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 30 (actual)
• Sponsor: Ipsen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Timeline

• Start date: 2025-07-16
• Primary completion: 2026-02-23
• Completion: 2026-02-23
• First posted: 2025-07-03
• Last updated: 2026-04-01

Locations

3 sites across 1 country: United States