A new study sponsored by Ipsen is currently recruiting patients with primary biliary cholangitis (PBC) to analyze patterns of scratching and sleep by using a wearable sensor.
“People living with PBC often face challenges like intense itching, trouble sleeping, and feeling constantly tired,” the study overview explains. “These symptoms can make it hard for them to enjoy daily life and feel well overall.”
The goal of the research is to use the ADAM sensor to measure patient behaviors, meaning participants do not have to remember and report their scratch and sleep patterns to the investigators. This allows for much more objective measurement of patient data and takes some of the burden off of the participants.
To be eligible, individuals must be at least 18 years of age with a confirmed diagnosis of PBC. Participants must wear the sensor for seven nights in a row across four different seven-day periods.
Read more about PBC signs and symptoms
The sensor will measure the number of times a patient scratches while asleep, as well as categorize the scratching behavior as low- or high-intensity. Additionally, the study will monitor the durations of scratching, sleep and wakefulness during the nighttime.
Recruitment is currently taking place in three centers in Arizona, Florida and Texas. The study aims to enroll about 30 individuals, who will each be expected to be involved in the study for around 91 days.
Patients will also have their baseline liver function measured via blood tests in order to determine potential links between liver health, scratching and sleep.
Individuals who have skin conditions associated with itchiness and those with nerve conditions that cause tremors are unable to join this study.
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