This study will collect information from patients with Primary Biliary Cholangitis (PBC). PBC is a progressive rare liver disease in which tubes in the liver called bile ducts are damaged. The liver damage in PBC may lead to scarring (cirrhosis). People living with PBC often face challenges like intense itching, trouble sleeping, and feeling constantly tired. These symptoms can make it hard for them to enjoy daily life and feel well overall. While itching and sleep patterns can be difficult to measure accurately based on recall and may lack precision, the main aim of this study is to use a digital health tool to assess the severity of itchiness and sleep patterns in people with PBC. The tool will take the objective measurement for people so they do not have to recall their scratch and sleep patterns. The total study duration for each patient will be about 91 days.
Study Type
OBSERVATIONAL
Enrollment
30
Arizona Liver Center
Chandler, Arizona, United States
University of Miami School of Medicine, Center for Liver Diseases
Miami, Florida, United States
UT Southwestern Medical Center, Department of Internal Medicine, Digestive and Liver Diseases
Dallas, Texas, United States
Number of Nocturnal Scratch Events
Defined as the total number of scratch events detected during sleep periods, monitored using the Nighttime sensor wear. This outcome will be assessed at the end of the wear period.
Time frame: At weeks 0, 4, 8 and 12
Frequency of Low- and High-Intensity Nocturnal Scratch Events
Defined as the frequency of scratch events categorized into low- and high-intensity levels during sleep periods, as detected by the Nighttime sensor wear. This outcome will be assessed at the end of the wear period.
Time frame: At weeks 0, 4, 8 and 12
Average Scratch Intensity Per Night
Defined as the average intensity of scratch events per night, calculated from data recorded by the Nighttime sensor wear. This outcome will be assessed at the end of the wear period.
Time frame: At weeks 0, 4, 8 and 12
Hourly Frequency of Nocturnal Scratch Events During Sleep
Defined as the frequency of nocturnal scratch events occurring per hour during sleep periods, recorded using the Nighttime sensor wear. This outcome will be assessed at the end of the wear period.
Time frame: At weeks 0, 4, 8 and 12
Average Duration of Scratch Events Per Night
Defined as the average duration of scratch events occurring during sleep periods, calculated using data collected via the Nighttime sensor wear. This outcome will be assessed at the end of the wear period.
Time frame: At weeks 0, 4, 8 and 12
Total Duration of Scratch Behavior Per Patient During Sleep Periods
Defined as the total duration of scratch events recorded for each patient during sleep periods using the Nighttime sensor wear. This outcome will be assessed at the end of the wear period.
Time frame: At weeks 0, 4, 8 and 12
Total Sleep Duration (Hours)
Defined as the total duration of sleep per patient, recorded by the Nighttime sensor wear. This outcome will be assessed at the end of the wear period.
Time frame: At weeks 0, 4, 8 and 12
Duration of Wakefulness After Sleep Onset (WASO, Minutes)
Defined as the total duration of wakefulness after the initial onset of sleep, measured using the Nighttime sensor wear. This outcome will be assessed at the end of the wear period.
Time frame: At weeks 0, 4, 8 and 12
Duration of Wakefulness During Scratch Periods
Defined as the total duration of wakefulness during scratch periods, monitored via the Nighttime sensor wear. This outcome will be assessed at the end of the wear period.
Time frame: At weeks 0, 4, 8 and 12
Average Sleep Duration Between Scratch Periods
Defined as the average duration of sleep occurring between scratch periods, as measured by the Nighttime sensor wear. This outcome will be assessed at the end of the wear period.
Time frame: At weeks 0, 4, 8 and 12
Demographic Data: Age at Enrollment
Defined as the age of patients recorded at the time of enrollment.
Time frame: At enrollment visit (Week 0, Day 1)
Demographic Data: Sex at Enrollment
Defined as the sex of patients recorded at the time of enrollment.
Time frame: At enrollment visit (Week 0, Day 1)
Age at Diagnosis (As Available)
Defined as the patient's age at the time of diagnosis, as reported in their medical history.
Time frame: At enrollment visit (Week 0, Day 1)
Age at First Symptoms (As Available)
Defined as the patient's age when first symptoms were reported, based on medical records or patient recollection.
Time frame: At enrollment visit (Week 0, Day 1)
Time Duration Since PBC Diagnosis
Defined as the duration between the patient's initial diagnosis of PBC and the time of enrollment, as recorded in their medical history.
Time frame: At enrollment visit (Week 0, Day 1)
Current PBC-Related Treatments
Defined as the treatments patients are currently receiving for PBC, including medication and other therapies, as reported at enrollment.
Time frame: At enrollment visit (Week 0, Day 1)
Time Duration on Current PBC-Related Treatment
Defined as the duration for which patients have been receiving their current PBC-related treatment, as recorded during enrollment.
Time frame: At enrollment visit (Week 0, Day 1)
Concomitant Medications for Itch/Scratch and/or Sleep Disturbances
Defined as the additional medications patients are currently using to manage itch/scratch and/or sleep disturbances, as reported at enrollment.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: At enrollment visit (Week 0, Day 1)
Baseline Liver Function Tests: Alanine aminotransferase (ALT) Levels
Time frame: At enrollment visit (Week 0, Day 1)
Baseline Liver Function Tests: Aspartate aminotransferase (AST) Levels
Time frame: At enrollment visit (Week 0, Day 1)
Baseline Liver Function Tests: Alkaline phosphatase (ALP) Levels
Time frame: At enrollment visit (Week 0, Day 1)
Baseline Liver Function Tests: Bilirubin Levels
Time frame: At enrollment visit (Week 0, Day 1)
Baseline Liver Function Tests: Albumin Levels
Time frame: At enrollment visit (Week 0, Day 1)
Baseline Enhanced Liver Fibrosis (ELF) Test: Hyaluronic Acid (HA) Levels
Time frame: At enrollment visit (Week 0, Day 1)
Baseline ELF Test: Procollagen Type III Amino-Terminal Propeptide (PIIINP) Levels
Time frame: At enrollment visit (Week 0, Day 1)
Baseline ELF Test: Tissue Inhibitor of Metalloproteinase-1 (TIMP-1) Levels
Time frame: At enrollment visit (Week 0, Day 1)
Baseline Liver Stiffness Measurement by Fibroscan
Time frame: At enrollment visit (Week 0, Day 1)
PBC Worst Itch Numeric Rating Scale (PBC WI NRS) Score
Defined as the patient's score on the PBC WI NRS, assessing the severity of worst itch experienced during the study duration.
Time frame: At weeks 0, 4, 8 and 12
PBC-40 Itch Severity Score
Defined as the patient's score on the itch severity domain of the PBC-40 questionnaire, measuring the impact of itch on their quality of life.
Time frame: At weeks 0, 4, 8 and 12
Duration, degree, direction, disability, and distribution (5-D) Itch Scale
Defined as the patient's score on the 5-D Itch Scale, capturing dimensions of duration, degree, direction, disability, and distribution of itch.
Time frame: At weeks 0, 4, 8 and 12
PBC-40 Fatigue Severity Score
Defined as the patient's score on the fatigue severity domain of the PBC-40 questionnaire, quantifying the impact of fatigue on their daily life.
Time frame: At weeks 0, 4, 8 and 12
Sleep Disturbance Numeric Rating Scale (SD NRS) Score
Defined as the patient's score on the SD NRS, evaluating the severity of sleep disturbances experienced during the study duration.
Time frame: At weeks 0, 4, 8 and 12
Patient-Reported Outcomes Measurement Information System® (PROMIS®) Fatigue Short Form (SF)-7a Score
Defined as the patient's score on the PROMIS® Fatigue SF-7a, assessing fatigue levels and their effects on physical, mental, and social activities.
Time frame: At weeks 0, 4, 8 and 12
Percentage of Patient Responses to Sibel Health System Usability Survey (SUS)
Defined as the patients' feedback on the usability of the Sibel Health System, captured through the SUS administered during enrollment. This outcome will assess user experience and satisfaction with the system.
Time frame: At week 12 (End of Study Survey)