Using Digital Health Technology to Monitor Patients With Primary Biliary Cholangitis (PBC)
2026年6月8日 更新者：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.
調査の概要
状態
招待による登録
詳細な説明
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.
研究の種類
観察的
入学 (推定)
30
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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California
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Redwood City、California、アメリカ、94063
- Stanford University School of Medicine
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
サンプリング方法
非確率サンプル
調査対象母集団
30 adult patients, diagnosed with PBC and with abnormal alkaline phosphatase (ALP)
説明
Inclusion Criteria:
PBC diagnosis based on meeting 2 of 3 criteria:
- Cholestatic liver biochemistry at disease outset (defined as elevation in the serum ALP level or GGT).
- 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.
- Diagnostic or compatible liver biopsy.
- Ability to provide informed consent
- Ability to complete digital questionnaires
- 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:
- Uncontrolled chronic inflammatory condition that is likely to contribute to symptoms of poor fatigue and sleep and confound results.
- Active malignancy requiring treatment
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
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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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Sleep scores to assess sleep quality will be measured in PBC patients using a wearable device
時間枠：7 months (1 month of screening and 6 months wearing device)
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Sleep Score 0 - 100 where 0 is worst sleep experience and 100 is best sleep experience
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7 months (1 month of screening and 6 months wearing device)
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SpO2 (saturation of peripheral oxygen) levels to assess sleep quality
時間枠：7 months (1 month of screening and 6 months wearing device)
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7 months (1 month of screening and 6 months wearing device)
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Total time in bed, to assess sleep quality
時間枠：7 months (1 month of screening and 6 months wearing device)
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Number of hours per day spent in bed
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7 months (1 month of screening and 6 months wearing device)
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Total sleep, to assess sleep quality
時間枠：7 months (1 month of screening and 6 months wearing device)
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Number of hours per day spent asleep
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7 months (1 month of screening and 6 months wearing device)
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Sleep stage time series (REM), to assess sleep quality
時間枠：7 months (1 month of screening and 6 months wearing device)
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Number of hours per day spent in REM (Rapid Eye Movement) sleep
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7 months (1 month of screening and 6 months wearing device)
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Sleep stage time series (deep), to assess sleep quality
時間枠：7 months (1 month of screening and 6 months wearing device)
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Number of hours per day spent in deep sleep
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7 months (1 month of screening and 6 months wearing device)
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Sleep stage time series (light), to assess sleep quality
時間枠：7 months (1 month of screening and 6 months wearing device)
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Number of hours per day spent in light sleep
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7 months (1 month of screening and 6 months wearing device)
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Number of "get ups" during sleep, to assess sleep quality
時間枠：7 months (1 month of screening and 6 months wearing device)
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Number of times "getting up" during the night while trying to sleep
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7 months (1 month of screening and 6 months wearing device)
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Temperature deviation from baseline, to assess sleep quality
時間枠：7 months (1 month of screening and 6 months wearing device)
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change in temperature over time during sleep cycle
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7 months (1 month of screening and 6 months wearing device)
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Heart rate
時間枠：7 months (1 month of screening and 6 months wearing device)
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7 months (1 month of screening and 6 months wearing device)
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Respiratory rate
時間枠：7 months (1 month of screening and 6 months wearing device)
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7 months (1 month of screening and 6 months wearing device)
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Calories burned during exercise to assess daily activity
時間枠：7 months (1 month of screening and 6 months wearing device)
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Number of calories burned during each exercise session
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7 months (1 month of screening and 6 months wearing device)
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Calories burned throughout the day to assess daily activity
時間枠：7 months (1 month of screening and 6 months wearing device)
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total number of calories burned each day
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7 months (1 month of screening and 6 months wearing device)
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Distance traveled during exercise to assess daily activity
時間枠：7 months (1 month of screening and 6 months wearing device)
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Number of miles traveled during each exercise session
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7 months (1 month of screening and 6 months wearing device)
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Number of steps to assess daily activity
時間枠：7 months (1 month of screening and 6 months wearing device)
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total number of steps taken each day
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7 months (1 month of screening and 6 months wearing device)
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Change in PBC-40 fatigue domain score in patients with PBC
時間枠：7 months (1 month screening and 6 months wearing the device)
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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.
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7 months (1 month screening and 6 months wearing the device)
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in alkaline phosphatase (ALP) levels
時間枠：Baseline and following 2L therapy (at doctor's discretion, within 7 month timeline)
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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.
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Baseline and following 2L therapy (at doctor's discretion, within 7 month timeline)
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Changes in Daily Fatigue Impact Scale.
時間枠：7 months (1 month screening and 6 months wearing the device)
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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.
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7 months (1 month screening and 6 months wearing the device)
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Change in Epworth Sleepiness Scale (ESS) score
時間枠：7 months (1 month screening and 6 months wearing the device)
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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.
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7 months (1 month screening and 6 months wearing the device)
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年7月1日
一次修了 (推定)
2027年10月1日
研究の完了 (推定)
2028年4月1日
試験登録日
最初に提出
2026年5月4日
QC基準を満たした最初の提出物
2026年6月1日
最初の投稿 (実際)
2026年6月8日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月11日
QC基準を満たした最後の更新が送信されました
2026年6月8日
最終確認日
2026年6月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 83091
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いいえ
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