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

8. juni 2026 oppdatert av: Aparna Goel, Stanford University

Characterizing Fatigue, Sleep and Activity in Patients Living With Primary Biliary Cholangitis (PBC) Using Digital Health Technology

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.

Studieoversikt

Status

Påmelding etter invitasjon

Forhold

Detaljert beskrivelse

Patients enrolled are intended to start a second-line therapy (2L) for control of their PBC - the choice of therapy will be at the discretion of the treating hepatologist. Once 2L therapy is initiated, the study will assess for correlations between changes in biochemistries (alkaline phosphatase, or ALP) with biometrics and PRO results.

Studietype

Observasjonsmessig

Registrering (Antatt)

30

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • California
      • Redwood City, California, Forente stater, 94063
        • Stanford University School of Medicine

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

30 adult patients, diagnosed with PBC and with abnormal alkaline phosphatase (ALP)

Beskrivelse

  • Inclusion Criteria:

    1. PBC diagnosis based on meeting 2 of 3 criteria:

      1. Cholestatic liver biochemistry at disease outset (defined as elevation in the serum ALP level or GGT).
      2. Associated autoantibody (AMA or PBC-associated antinuclear antibody by immune fluorescence or anti-PDC, anti-Gp210, or anti-Sp100) at a titer of greater than or equal to 1:40.
      3. Diagnostic or compatible liver biopsy.
    2. Ability to provide informed consent
    3. Ability to complete digital questionnaires
    4. Elevated alkaline phosphatase
  • Abbreviations:

alkaline phosphatase [ALP] gamma-glutamyl-transferase [GGT] antimitochondrial antibody [AMA] Primary Biliary Cholangitis [PBC] Plasmacytoid dendritic cells [PDC] glycoprotein 210 [Gp210] Scleroderma 100 [Sp100]

Exclusion Criteria:

  1. Uncontrolled chronic inflammatory condition that is likely to contribute to symptoms of poor fatigue and sleep and confound results.
  2. Active malignancy requiring treatment

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Sleep scores to assess sleep quality will be measured in PBC patients using a wearable device
Tidsramme: 7 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
7 months (1 month of screening and 6 months wearing device)
SpO2 (saturation of peripheral oxygen) levels to assess sleep quality
Tidsramme: 7 months (1 month of screening and 6 months wearing device)
7 months (1 month of screening and 6 months wearing device)
Total time in bed, to assess sleep quality
Tidsramme: 7 months (1 month of screening and 6 months wearing device)
Number of hours per day spent in bed
7 months (1 month of screening and 6 months wearing device)
Total sleep, to assess sleep quality
Tidsramme: 7 months (1 month of screening and 6 months wearing device)
Number of hours per day spent asleep
7 months (1 month of screening and 6 months wearing device)
Sleep stage time series (REM), to assess sleep quality
Tidsramme: 7 months (1 month of screening and 6 months wearing device)
Number of hours per day spent in REM (Rapid Eye Movement) sleep
7 months (1 month of screening and 6 months wearing device)
Sleep stage time series (deep), to assess sleep quality
Tidsramme: 7 months (1 month of screening and 6 months wearing device)
Number of hours per day spent in deep sleep
7 months (1 month of screening and 6 months wearing device)
Sleep stage time series (light), to assess sleep quality
Tidsramme: 7 months (1 month of screening and 6 months wearing device)
Number of hours per day spent in light sleep
7 months (1 month of screening and 6 months wearing device)
Number of "get ups" during sleep, to assess sleep quality
Tidsramme: 7 months (1 month of screening and 6 months wearing device)
Number of times "getting up" during the night while trying to sleep
7 months (1 month of screening and 6 months wearing device)
Temperature deviation from baseline, to assess sleep quality
Tidsramme: 7 months (1 month of screening and 6 months wearing device)
change in temperature over time during sleep cycle
7 months (1 month of screening and 6 months wearing device)
Heart rate
Tidsramme: 7 months (1 month of screening and 6 months wearing device)
7 months (1 month of screening and 6 months wearing device)
Respiratory rate
Tidsramme: 7 months (1 month of screening and 6 months wearing device)
7 months (1 month of screening and 6 months wearing device)
Calories burned during exercise to assess daily activity
Tidsramme: 7 months (1 month of screening and 6 months wearing device)
Number of calories burned during each exercise session
7 months (1 month of screening and 6 months wearing device)
Calories burned throughout the day to assess daily activity
Tidsramme: 7 months (1 month of screening and 6 months wearing device)
total number of calories burned each day
7 months (1 month of screening and 6 months wearing device)
Distance traveled during exercise to assess daily activity
Tidsramme: 7 months (1 month of screening and 6 months wearing device)
Number of miles traveled during each exercise session
7 months (1 month of screening and 6 months wearing device)
Number of steps to assess daily activity
Tidsramme: 7 months (1 month of screening and 6 months wearing device)
total number of steps taken each day
7 months (1 month of screening and 6 months wearing device)
Change in PBC-40 fatigue domain score in patients with PBC
Tidsramme: 7 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.
7 months (1 month screening and 6 months wearing the device)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in alkaline phosphatase (ALP) levels
Tidsramme: Baseline and following 2L therapy (at doctor's discretion, within 7 month timeline)
ALP levels (where lower levels reflect better control of PBC disease) will be measured in patients both before and after a second-line therapy (2L) is started.
Baseline and following 2L therapy (at doctor's discretion, within 7 month timeline)
Changes in Daily Fatigue Impact Scale.
Tidsramme: 7 months (1 month screening and 6 months wearing the device)
The Daily Fatigue Impact Scale measures how fatigue interferes with daily functioning. Scores range from 0 to 32, with higher numbers indicating a greater severity of fatigue.
7 months (1 month screening and 6 months wearing the device)
Change in Epworth Sleepiness Scale (ESS) score
Tidsramme: 7 months (1 month screening and 6 months wearing the device)
The ESS score (the sum of 8 item scores, 0-3) can range from 0 to 24. A result from 11 to 24 indicates excessive (abnormal) daytime sleepiness.
7 months (1 month screening and 6 months wearing the device)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Stanford University

Samarbeidspartnere

Gilead Sciences

Etterforskere

  • Hovedetterforsker: Aparna Goel, MD, Stanford University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. juli 2026

Primær fullføring (Antatt)

1. oktober 2027

Studiet fullført (Antatt)

1. april 2028

Datoer for studieregistrering

Først innsendt

4. mai 2026

Først innsendt som oppfylte QC-kriteriene

1. juni 2026

Først lagt ut (Faktiske)

8. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

11. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

8. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 83091

Plan for individuelle deltakerdata (IPD)

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NEI

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Studerer et amerikansk FDA-regulert medikamentprodukt

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Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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