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NCT07631442

Using Digital Health Technology to Monitor Patients With Primary Biliary Cholangitis (PBC)

Enrolling by Invitation
Not specifiedAges 18+Observational
Stanford University
~30 participants
Updated 2026-06-11 on ClinicalTrials.gov

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Sleep scores to assess sleep quality will be measured in PBC patients using a wearable device
Measured over 7 months (1 month of screening and 6 months wearing device)
+15 more outcomes measured

Conditions

Primary Biliary Cholangitis (PBC)

Explore related trials

Primary Biliary Cirrhosis

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Aparna Goel, MD · PRINCIPAL_INVESTIGATOR · Stanford University

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

Abbreviations:

What this trial measures

  • Sleep scores to assess sleep quality will be measured in PBC patients using a wearable device7 months (1 month of screening and 6 months wearing device)

    Sleep Score 0 - 100 where 0 is worst sleep experience and 100 is best sleep experience

  • SpO2 (saturation of peripheral oxygen) levels to assess sleep quality7 months (1 month of screening and 6 months wearing device)
  • Total time in bed, to assess sleep quality7 months (1 month of screening and 6 months wearing device)

    Number of hours per day spent in bed

  • Total sleep, to assess sleep quality7 months (1 month of screening and 6 months wearing device)

    Number of hours per day spent asleep

  • Sleep stage time series (REM), to assess sleep quality7 months (1 month of screening and 6 months wearing device)

    Number of hours per day spent in REM (Rapid Eye Movement) sleep

  • Sleep stage time series (deep), to assess sleep quality7 months (1 month of screening and 6 months wearing device)

    Number of hours per day spent in deep sleep

  • Sleep stage time series (light), to assess sleep quality7 months (1 month of screening and 6 months wearing device)

    Number of hours per day spent in light sleep

  • Number of "get ups" during sleep, to assess sleep quality7 months (1 month of screening and 6 months wearing device)

    Number of times "getting up" during the night while trying to sleep

  • Temperature deviation from baseline, to assess sleep quality7 months (1 month of screening and 6 months wearing device)

    change in temperature over time during sleep cycle

  • Heart rate7 months (1 month of screening and 6 months wearing device)
  • Respiratory rate7 months (1 month of screening and 6 months wearing device)
  • Calories burned during exercise to assess daily activity7 months (1 month of screening and 6 months wearing device)

    Number of calories burned during each exercise session

  • Calories burned throughout the day to assess daily activity7 months (1 month of screening and 6 months wearing device)

    total number of calories burned each day

  • Distance traveled during exercise to assess daily activity7 months (1 month of screening and 6 months wearing device)

    Number of miles traveled during each exercise session

  • Number of steps to assess daily activity7 months (1 month of screening and 6 months wearing device)

    total number of steps taken each day

  • Change in PBC-40 fatigue domain score in patients with PBC7 months (1 month screening and 6 months wearing the device)

    The PBC-40 fatigue domain allows a potential value range of 11 to 55 with higher values denoting worse fatigue. A score of \>33 identifies patients with moderate-severe fatigue and a mean change in this score by 5 points after 3 months has been used in other studies to denote clinically meaningful significance.