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シェーグレン症候群の疲労：3治療戦略 (FESSONA)

2026年9月29日 更新者：Centre Hospitalier Universitaire de Saint Etienne

シェーグレン症候群の疲労：非薬理学的治療戦略の組み合わせのランダム化比較試験

Unexplained fatigue is a frequent (60-70%) chronic complaint in Sjögren's syndrome (SjS) with a clear unmet therapeutic need, despite the recommendation of adapted physical activity (APA) programs, which are effective and feasible, but only to some extent. Hence, other therapeutic approaches, such as Acupuncture (ACU) or transcutaneous vagal nerve stimulation (tVNS), have been evaluated during the past years, with varying degrees of success in alleviating fatigue.

FESSONA has been designed as a randomized controlled monocentric trial, aiming at comparing the effects of 3 different programs on fatigue in SjS: APA alone, APA+ACU and APA+tVNS. Relevant controls will be included as well (sham ACU and simulated tVNS).

Multiple fatigue and SjS-related features will be measured before (at inclusion) and after (week 12) the intervention, as well as at week 24 and 48, to evaluate the short- and long-term impact of each program. Tolerance and feasibility will also be evaluated.

調査の概要

状態

募集

条件

介入・治療

研究の種類

介入

入学 (推定)

174

段階

  • 適用できない

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。

研究連絡先

研究連絡先のバックアップ

研究場所

  • フランス
      • Saint-Etienne、フランス、42055
        • 募集
        • Chu de Saint-Etienne
        • 副調査官：
          • David HUPIN, MD
        • 副調査官：
          • Hubert MAROTTE, MD PhD
        • 副調査官：
          • Baptiste GRAMONT, MD
        • コンタクト：
        • コンタクト：
        • 副調査官：
          • Lucile GRANGE, MD

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

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

Inclusion Criteria:

  • Patient affiliated or entitled to a social security scheme.
  • Age > 18 years.
  • Patient informed and having signed the information form and consent to participate in the study.
  • Patient with Sjögren's syndrome according to ACR/EULAR 2016 or AECG 2002 criteria, usually followed up every year or more frequently
  • Fatigue present for ≥ 6 months, without obvious explanation and/or specific treatment to conduct (e.g., disease's flare, chronic infection), with a current FACIT-F score < 34

Exclusion Criteria:

  • Pre-existing atrial fibrillation or severe cardiac conduction disorders,
  • Recent stroke or myocardial infarction (<6 months),
  • Left ventricular ejection fraction <40% or severe heart failure (New York Heart Association functional class III or IV)
  • Recurrent episodes of vasovagal syncope, or history of vagotomy
  • People with dermatological problems in the area where the stimulation electrodes are to be placed
  • Current episode of venous or arterial thrombosis
  • Pregnancy or breastfeeding
  • Patient under protective measures (legal protection, curatorship, guardianship)
  • Inability or refusal to understand and/or sign informed consent to participate in the study, or to perform follow-up examinations required under the study

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

  • 主な目的：他の
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：APA + SHAM ACU + TVNS
デバイス：Transcutaneous Vagus Nerve Stimulation (tVNS)

Transcutaneous Vagus Nerve Stimulation (tVNS) will be performed using an ECO TENS 2 device with an ear clip put in the conque aurea of the left ear, which is innervated by the auricular branch of the vagus nerve. In the groups receiving simulated tVNS, stimulation will be delivered to the ear lobe, which is devoid of vagal innervation.

Stimulation will be delivered at a frequency of 20 Hz and a pulse width of 200 ms, while the stimulation amplitude will be individually titrated to 1 mA below the level that will lead to a mild unpleasant feeling, according to the parameters defined by Stavrakis et al (2017, 2020).

他の：APA (adapted physical activity )

The APA (adapted physical activity ) program : 2 sessions of 90 min (with 60 min of aerobic exercise and 30 min of resistance exercises per session) per week, for 12 consecutive weeks

デバイス：Acupuncture (sham_ACU)

Needles well be used in the non-acupoint area 2 centimeters away from the real acupoints. The needles will remain for 30 min. Subjects will receive sham acupuncture twice a week during the 12-week intervention.
実験的：APA + ACU +シミュレーションTVNS
他の：APA (adapted physical activity )

The APA (adapted physical activity ) program : 2 sessions of 90 min (with 60 min of aerobic exercise and 30 min of resistance exercises per session) per week, for 12 consecutive weeks

デバイス：Acupuncture (ACU)

acupoints will be Baihui (GV20); Zhongwan (CV12), Guanyuan (CV4), bilateral Zusanli (ST36) bilateral Taichong (LV3). The needles will remain for 30 min. Subjects will receive acupuncture twice a week during the 12-week intervention.

デバイス：Simulated Transcutaneous Vagus Nerve Stimulation (sim_tVNS)

Simulated Transcutaneous Vagus Nerve Stimulation (sim_tVNS) will be performed using an ECO TENS 2 device with an ear clip put in the conque aurea of the left ear, which is innervated by the auricular branch of the vagus nerve. NSVt devices will be used in "simulated" mode.
偽コンパレータ：APA +シミュレートされたTVNS + SHAM ACU
他の：APA (adapted physical activity )

The APA (adapted physical activity ) program : 2 sessions of 90 min (with 60 min of aerobic exercise and 30 min of resistance exercises per session) per week, for 12 consecutive weeks

デバイス：Acupuncture (sham_ACU)

Needles well be used in the non-acupoint area 2 centimeters away from the real acupoints. The needles will remain for 30 min. Subjects will receive sham acupuncture twice a week during the 12-week intervention.

デバイス：Simulated Transcutaneous Vagus Nerve Stimulation (sim_tVNS)

Simulated Transcutaneous Vagus Nerve Stimulation (sim_tVNS) will be performed using an ECO TENS 2 device with an ear clip put in the conque aurea of the left ear, which is innervated by the auricular branch of the vagus nerve. NSVt devices will be used in "simulated" mode.

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
Change in fatigue score assessed
時間枠：Between inclusion (week 0) and visit V1 at 12 weeks (± 1 week from the end of the 12-week program)

Change in fatigue score assessed using the FACIT-F questionnaire (Functional Assessment of Chronic Illness Therapy - Fatigue; ranging from 0 to 52, 0 meaning extreme fatigue and 52 the total absence of fatigue)
Between inclusion (week 0) and visit V1 at 12 weeks (± 1 week from the end of the 12-week program)

二次結果の測定

結果測定
メジャーの説明
時間枠
異なるグループで実行された24のAPAセッションの割合（％）（提案された演習の少なくとも80％）
時間枠：48週
48週
FACIT-F score in the different groups
時間枠：between inclusion (Week 0) and week 48

FACIT-F score at 48 weeks, in the different groups
between inclusion (Week 0) and week 48
Root Mean Square of the Successive Differences in heart rate or RMSSD (in milliseconds)
時間枠：at 12, 24 and 48 weeks,

Root Mean Square of the Successive Differences in heart rate or RMSSD (in milliseconds), measured from a nocturnal ECG recording by Holter ECG, in the different groups
at 12, 24 and 48 weeks,
ClinESSDAI score
時間枠：at 12, 24 and 48 weeks,

ClinESSDAI score (clinical part of the EULAR Sjögren's Syndrome Disease Activity Index; assessed on 11 "domains" corresponding to the main clinical manifestations of the disease; ranging from 0 to 135, a score of 0 meaning the existence of a disease and a score of 135 a disease whose activity would be maximal) in the different groups
at 12, 24 and 48 weeks,
ESSPRI questionnaire (EULAR Sjögren's Syndrome Patient Reported Index)
時間枠：at 12, 24 and 48 weeks

ESSPRI questionnaire (EULAR Sjögren's Syndrome Patient Reported Index); calculated as the mean of 3 self-measurement scales assessing fatigue, dryness and pain, each ranging from 0 to 10; 0 meaning the total absence of the symptom considered and 10 a symptom whose intensity would be at the maximum imaginable) in the different groups
at 12, 24 and 48 weeks
HADS questionnaire (Hospital Anxiety and Depression Scale)
時間枠：at 12, 24 and 48 weeks

HADS questionnaire (Hospital Anxiety and Depression Scale) composed of an anxiety score and a depression score both ranging from 0 to 21, 0 meaning the absence of symptoms of this type, and 21 the presence of an anxiety and/or major depressive state) in the different groups
at 12, 24 and 48 weeks
Self-measurement questionnaire SF-36 (Short Form Health Survey 36)
時間枠：between inclusion (Week 0) and week 48

Self-measurement questionnaire SF-36 (Short Form Health Survey 36); comprising 36 questions assessing 8 dimensions, namely physical functioning, role limitation due to physical problems, role limitation resulting from emotional problems, vitality (energy/fatigue), emotional well-being, social functioning, bodily pain, and perception of general and mental health; each dimension is represented by a score ranging from 0 to 100, with a low score signifying poor health perception in the dimension considered, and a high score signifying the opposite)
between inclusion (Week 0) and week 48
EQ-5D-5L self-measurement questionnaire assessing 5 dimensions of health
時間枠：at 12, 24, and 48 weeks,

EQ-5D-5L self-measurement questionnaire assessing 5 dimensions of health (mobility, autonomy, daily activities, pain/discomfort and anxiety/depression) with 1 question per domain, with the possibility of choosing 5 degrees of severity each time (1 corresponding to no difficulty for the domain and 5 corresponding to the maximum degree of difficulty in the domain), the total of the 5 notes of the 5 domains giving a score ranging from 5 to 25, and this questionnaire is associated with a visual analogue scale (VAS) allowing the patient to rate his state of health of the day from 0 (the worst state of health imaginable) to 100 (the best state of health imaginable), in the different groups
at 12, 24, and 48 weeks,
Schirmer test
時間枠：at 12, 24 and 48 weeks

the area of the graduated blotter that became wet after 5 min of placement on the lower eyelid of each eye, expressed in millimeters and as the average of the two eyes) at 12, 24 and 48 weeks, in the different groups
at 12, 24 and 48 weeks
VO2max
時間枠：at 12, 24 and 48 weeks

VO2max (in ml/min/kg; after metabolic test) in the different groups
at 12, 24 and 48 weeks
Handgrip test
時間枠：at 12, 24 and 48 weeks

Handgrip test (in kg; via a grip test on the dominant upper limb) in the different groups
at 12, 24 and 48 weeks
Number of daily steps
時間枠：at 12, 24 and 48 weeks

Number of daily steps measured via a connected watch on average over the week preceding the assessments at 12, 24 and 48 weeks, in the different groups
at 12, 24 and 48 weeks

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。

スポンサー

Centre Hospitalier Universitaire de Saint Etienne

捜査官

  • 主任研究者：Martin KILLIAN, MD

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

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 (実際)

2026年3月24日

一次修了 (推定)

2027年4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

2025年2月4日

QC基準を満たした最初の提出物

2025年3月10日

最初の投稿 (実際)

2025年3月13日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月30日

QC基準を満たした最後の更新が送信されました

2026年9月29日

最終確認日

2026年9月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • 24CH125
  • ANSM (その他の識別子：2024-A02116-41)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

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いいえ

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いいえ

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