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Can a smartwatch help manage a rare liver disease? stanford study investigates

NCT ID NCT07631442

Knowledge-focused Sponsor: Stanford University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study at Stanford University is testing whether wearable devices like smartwatches can help measure fatigue, sleep, and daily activity in people with primary biliary cholangitis (PBC), a chronic liver disease. Researchers will compare data from the wearables with patient questionnaires and lab tests to see if changes in activity or sleep patterns match disease activity. The study involves 30 participants and aims to find better ways to monitor PBC symptoms remotely.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could show that wearable devices can reliably track PBC symptoms, potentially leading to better remote monitoring and earlier detection of disease changes.
What could go wrong
This is a small, early observational study (30 people) with no treatment being tested. It may not prove that wearables are useful for all PBC patients, and results might not lead to any direct changes in care.

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

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Apr 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Who is studied

30 adult patients, diagnosed with PBC and with abnormal alkaline phosphatase (ALP)

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: 1. PBC diagnosis based on meeting 2 of 3 criteria: 1. Cholestatic liver biochemistry at disease outset (defined as elevation in the serum ALP level or GGT). 2. Associated autoantibody (AMA or PBC-associated antinuclear antibody by immune fluorescence or anti-PDC, anti-Gp210, or anti-Sp100) at a titer of greater than or equal to 1:40. 3. Diagnostic or compatible liver biopsy. 2. Ability to provide informed consent 3. Ability to complete digital questionnaires 4. Elevated alkaline phosphatase * Abbreviations: alkaline phosphatase \[ALP\] gamma-glutamyl-transferase \[GGT\] antimitochondrial antibody \[AMA\] Primary Biliary Cholangitis \[PBC\] Plasmacytoid dendritic cells \[PDC\] glycoprotein 210 \[Gp210\] Scleroderma 100 \[Sp100\] Exclusion Criteria: 1. Uncontrolled chronic inflammatory condition that is likely to contribute to symptoms of poor fatigue and sleep and confound results. 2. Active malignancy requiring treatment

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Conditions

The condition(s) this trial relates to.

Fatigue liver disorder Mental Fatigue primary biliary cholangitis Pruritus

As listed by the trial registrant

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

Primary biliary cholangitis (PBC)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Stanford University School of Medicine

    Redwood City, California, 94063, United States

More trials for these conditions

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