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

8. Juni 2026 aktualisiert von: 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.

Studienübersicht

Status

Anmeldung auf Einladung

Bedingungen

Detaillierte Beschreibung

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.

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

30

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Vereinigte Staaten
    • California
      • Redwood City, California, Vereinigte Staaten, 94063
        • Stanford University School of Medicine

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

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

Beschreibung

  • 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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Sleep scores to assess sleep quality will be measured in PBC patients using a wearable device
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 7 months (1 month of screening and 6 months wearing device)
7 months (1 month of screening and 6 months wearing device)
Respiratory rate
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in alkaline phosphatase (ALP) levels
Zeitfenster: 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.
Zeitfenster: 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
Zeitfenster: 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)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Stanford University

Mitarbeiter

Gilead Sciences

Ermittler

  • Hauptermittler: Aparna Goel, MD, Stanford University

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Juli 2026

Primärer Abschluss (Geschätzt)

1. Oktober 2027

Studienabschluss (Geschätzt)

1. April 2028

Studienanmeldedaten

Zuerst eingereicht

4. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

1. Juni 2026

Zuerst gepostet (Tatsächlich)

8. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

11. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

8. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 83091

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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