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Completed

NCT Number: NCT07049887

A Study Describing Scratch and Sleep Patterns in Patients With Primary Biliary Cholangitis (Luminaria)

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.

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Key information

Conditions

Primary Biliary Cholangitis Bile Duct Diseases Biliary Tract Diseases Cholestasis Cholestasis, Intrahepatic Digestive System Diseases Fibrosis Liver Cirrhosis Liver Cirrhosis, Biliary Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Arizona Liver Center, Chandler, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 18 years or older at time of study enrollment.
  • Confirmed diagnosis of PBC based on medical history and relevant clinical criteria, as determined by the study Investigator.
  • Willingness and ability to wear the ADAM sensor during the specified time periods (7 nights across four 7-day periods).
  • Able to read and write to ensure accurate completion of electronic PRO surveys.
  • Able to access an internet-connected device for the completion of electronic PRO surveys.
  • Able to provide signed, informed consent prior to collection of data.

Exclusion criteria

  • Has already been enrolled in another clinical study.
  • Has any dermatological conditions or severe comorbidities associated with pruritus as assessed by the investigators that may confound the measurement of scratch or sleep data.
  • Has any extrapyramidal syndrome including Parkinsonism, essential tremor, astasia/abasia, cerebellar syndrome.

Treatment and study plan

Primary outcomes

  1. Number of Nocturnal Scratch Events

    Time frame: At weeks 0, 4, 8 and 12

    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.

  2. Frequency of Low- and High-Intensity Nocturnal Scratch Events

    Time frame: At weeks 0, 4, 8 and 12

    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.

  3. Average Scratch Intensity Per Night

    Time frame: At weeks 0, 4, 8 and 12

    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.

  4. Hourly Frequency of Nocturnal Scratch Events During Sleep

    Time frame: At weeks 0, 4, 8 and 12

    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.

  5. Average Duration of Scratch Events Per Night

    Time frame: At weeks 0, 4, 8 and 12

    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.

  6. Total Duration of Scratch Behavior Per Patient During Sleep Periods

    Time frame: At weeks 0, 4, 8 and 12

    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.

  7. Total Sleep Duration (Hours)

    Time frame: At weeks 0, 4, 8 and 12

    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.

  8. Duration of Wakefulness After Sleep Onset (WASO, Minutes)

    Time frame: At weeks 0, 4, 8 and 12

    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.

  9. Duration of Wakefulness During Scratch Periods

    Time frame: At weeks 0, 4, 8 and 12

    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.

  10. Average Sleep Duration Between Scratch Periods

    Time frame: At weeks 0, 4, 8 and 12

    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.

Secondary outcomes

  1. Demographic Data: Age at Enrollment

    Time frame: At enrollment visit (Week 0, Day 1)

    Defined as the age of patients recorded at the time of enrollment.

  2. Demographic Data: Sex at Enrollment

    Time frame: At enrollment visit (Week 0, Day 1)

    Defined as the sex of patients recorded at the time of enrollment.

  3. Age at Diagnosis (As Available)

    Time frame: At enrollment visit (Week 0, Day 1)

    Defined as the patient's age at the time of diagnosis, as reported in their medical history.

  4. Age at First Symptoms (As Available)

    Time frame: At enrollment visit (Week 0, Day 1)

    Defined as the patient's age when first symptoms were reported, based on medical records or patient recollection.

  5. Time Duration Since PBC Diagnosis

    Time frame: At enrollment visit (Week 0, Day 1)

    Defined as the duration between the patient's initial diagnosis of PBC and the time of enrollment, as recorded in their medical history.

  6. Current PBC-Related Treatments

    Time frame: At enrollment visit (Week 0, Day 1)

    Defined as the treatments patients are currently receiving for PBC, including medication and other therapies, as reported at enrollment.

  7. Time Duration on Current PBC-Related Treatment

    Time frame: At enrollment visit (Week 0, Day 1)

    Defined as the duration for which patients have been receiving their current PBC-related treatment, as recorded during enrollment.

  8. Concomitant Medications for Itch/Scratch and/or Sleep Disturbances

    Time frame: At enrollment visit (Week 0, Day 1)

    Defined as the additional medications patients are currently using to manage itch/scratch and/or sleep disturbances, as reported at enrollment.

  9. Baseline Liver Function Tests: Alanine aminotransferase (ALT) Levels

    Time frame: At enrollment visit (Week 0, Day 1)

  10. Baseline Liver Function Tests: Aspartate aminotransferase (AST) Levels

    Time frame: At enrollment visit (Week 0, Day 1)

  11. Baseline Liver Function Tests: Alkaline phosphatase (ALP) Levels

    Time frame: At enrollment visit (Week 0, Day 1)

  12. Baseline Liver Function Tests: Bilirubin Levels

    Time frame: At enrollment visit (Week 0, Day 1)

  13. Baseline Liver Function Tests: Albumin Levels

    Time frame: At enrollment visit (Week 0, Day 1)

  14. Baseline Enhanced Liver Fibrosis (ELF) Test: Hyaluronic Acid (HA) Levels

    Time frame: At enrollment visit (Week 0, Day 1)

  15. Baseline ELF Test: Procollagen Type III Amino-Terminal Propeptide (PIIINP) Levels

    Time frame: At enrollment visit (Week 0, Day 1)

  16. Baseline ELF Test: Tissue Inhibitor of Metalloproteinase-1 (TIMP-1) Levels

    Time frame: At enrollment visit (Week 0, Day 1)

  17. Baseline Liver Stiffness Measurement by Fibroscan

    Time frame: At enrollment visit (Week 0, Day 1)

  18. PBC Worst Itch Numeric Rating Scale (PBC WI NRS) Score

    Time frame: At weeks 0, 4, 8 and 12

    Defined as the patient's score on the PBC WI NRS, assessing the severity of worst itch experienced during the study duration.

  19. PBC-40 Itch Severity Score

    Time frame: At weeks 0, 4, 8 and 12

    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.

  20. Duration, degree, direction, disability, and distribution (5-D) Itch Scale

    Time frame: At weeks 0, 4, 8 and 12

    Defined as the patient's score on the 5-D Itch Scale, capturing dimensions of duration, degree, direction, disability, and distribution of itch.

  21. PBC-40 Fatigue Severity Score

    Time frame: At weeks 0, 4, 8 and 12

    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.

  22. Sleep Disturbance Numeric Rating Scale (SD NRS) Score

    Time frame: At weeks 0, 4, 8 and 12

    Defined as the patient's score on the SD NRS, evaluating the severity of sleep disturbances experienced during the study duration.

  23. Patient-Reported Outcomes Measurement Information System® (PROMIS®) Fatigue Short Form (SF)-7a Score

    Time frame: At weeks 0, 4, 8 and 12

    Defined as the patient's score on the PROMIS® Fatigue SF-7a, assessing fatigue levels and their effects on physical, mental, and social activities.

  24. Percentage of Patient Responses to Sibel Health System Usability Survey (SUS)

    Time frame: At week 12 (End of Study Survey)

    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.

Sponsors and collaborators

Lead sponsor

Ipsen

Industry

Registry information

Official study title

A Multicenter Non-interventional Study for the Measurement of Scratch and Sleep Patterns Using the ADAM Sensor in Patients With Primary Biliary Cholangitis

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 3, 2025
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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