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Wearable device tracks itch and sleep in rare liver disease

NCT ID NCT07049887

Knowledge-focused Sponsor: Ipsen Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a wearable sensor called ADAM to measure scratching and sleep patterns in 30 people with primary biliary cholangitis (PBC), a rare liver disease that often causes intense itching and poor sleep. Participants wore the sensor for 7 nights across four 7-day periods over about 91 days. The goal was to see if the device could provide objective data on itch and sleep, rather than relying on people's memory.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

30 people

The number who actually took part.

Started

Jul 2025

Finished

Feb 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Adult patients diagnosed with PBC

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion 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. Exclusion Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

primary biliary cholangitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Primary biliary cholangitis

Contacts and locations

Locations

  • Arizona Liver Center

    Chandler, Arizona, 85224, United States

  • UT Southwestern Medical Center, Department of Internal Medicine, Digestive and Liver Diseases

    Dallas, Texas, 75390, United States

  • University of Miami School of Medicine, Center for Liver Diseases

    Miami, Florida, 33136, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.