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.
Age range
18 Years
Sex
ALL
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A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Sleep scores to assess sleep quality will be measured in PBC patients using a wearable device
Timeframe: 7 months (1 month of screening and 6 months wearing device)
SpO2 (saturation of peripheral oxygen) levels to assess sleep quality
Timeframe: 7 months (1 month of screening and 6 months wearing device)
Total time in bed, to assess sleep quality
Timeframe: 7 months (1 month of screening and 6 months wearing device)
Total sleep, to assess sleep quality
Timeframe: 7 months (1 month of screening and 6 months wearing device)
Sleep stage time series (REM), to assess sleep quality
Timeframe: 7 months (1 month of screening and 6 months wearing device)
Sleep stage time series (deep), to assess sleep quality
Timeframe: 7 months (1 month of screening and 6 months wearing device)
Sleep stage time series (light), to assess sleep quality
Timeframe: 7 months (1 month of screening and 6 months wearing device)
Number of "get ups" during sleep, to assess sleep quality
Timeframe: 7 months (1 month of screening and 6 months wearing device)
Temperature deviation from baseline, to assess sleep quality
Timeframe: 7 months (1 month of screening and 6 months wearing device)
Heart rate
Timeframe: 7 months (1 month of screening and 6 months wearing device)
Respiratory rate
Timeframe: 7 months (1 month of screening and 6 months wearing device)
Calories burned during exercise to assess daily activity
Timeframe: 7 months (1 month of screening and 6 months wearing device)
Calories burned throughout the day to assess daily activity
Timeframe: 7 months (1 month of screening and 6 months wearing device)
Distance traveled during exercise to assess daily activity
Timeframe: 7 months (1 month of screening and 6 months wearing device)
Number of steps to assess daily activity
Timeframe: 7 months (1 month of screening and 6 months wearing device)
Change in PBC-40 fatigue domain score in patients with PBC
Timeframe: 7 months (1 month screening and 6 months wearing the device)