The OURA Ring Study - Using Digital Health Technology to Monitor Patients With Primary Biliary Cholangitis (PBC)

Part of paid clinical trials in Redwood City, California.

Sponsor
Stanford University
Study ID
NCT07631442
Status
Enrolling By Invitation

Conditions

  • Primary Biliary Cholangitis (PBC)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

The purpose of this study is to explore the use of digital health technology for measuring symptoms and daily health in people with primary biliary cholangitis (PBC). Biometric data captured with a wearable device will be compared to questionnaire responses (patient-reported outcomes, or PROs) and laboratory test results to test the hypothesis that changes in biometrics can be correlated to changes in disease activity.

Key Dates

Start date
Jul 31, 2026
Status verified
May 2026
Primary completion
Oct 31, 2027
Completion
Apr 30, 2028

Study Design

Enrollment
30 participants (estimated)

Arms

  • Arm: Patients with Primary Biliary Cholangitis (PBC) and an abnormal alkaline phosphatase (ALP)
    Patients with an ALP \>1.67x ULN will be preferentially enrolled, but all patients with an elevated ALP can be considered.

Primary Outcome Measure

Sleep scores to assess sleep quality will be measured in PBC patients using a wearable device [ Time Frame: 7 months (1 month of screening and 6 months wearing device) ]

Locations (1)

FacilityCityStateZIP
Stanford University School of MedicineRedwood CityCalifornia94063

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By research site
Stanford University School of Medicine· Redwood City, CA

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