Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-26 @ 2:58 AM
Study NCT ID:
NCT06875102
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-08
First Post:
2025-02-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Fatigue in Sjögren's Syndrome: 3 Therapeutic Strategies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012859', 'term': "Sjogren's Syndrome"}, {'id': 'D005221', 'term': 'Fatigue'}], 'ancestors': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D014987', 'term': 'Xerostomia'}, {'id': 'D012466', 'term': 'Salivary Gland Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D015352', 'term': 'Dry Eye Syndromes'}, {'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015670', 'term': 'Acupuncture Therapy'}, {'id': 'D043384', 'term': 'Glutamyl Aminopeptidase'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D000626', 'term': 'Aminopeptidases'}, {'id': 'D020689', 'term': 'Exopeptidases'}, {'id': 'D010447', 'term': 'Peptide Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D045727', 'term': 'Metalloexopeptidases'}, {'id': 'D045726', 'term': 'Metalloproteases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 174}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2028-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-07', 'studyFirstSubmitDate': '2025-02-04', 'studyFirstSubmitQcDate': '2025-03-10', 'lastUpdatePostDateStruct': {'date': '2025-07-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in fatigue score assessed', 'timeFrame': 'Between inclusion (week 0) and visit V1 at 12 weeks (± 1 week from the end of the 12-week program)', 'description': '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)'}], 'secondaryOutcomes': [{'measure': 'FACIT-F score in the different groups', 'timeFrame': 'between inclusion (Week 0) and week 48', 'description': 'FACIT-F score at 48 weeks, in the different groups'}, {'measure': 'Root Mean Square of the Successive Differences in heart rate or RMSSD (in milliseconds)', 'timeFrame': 'at 12, 24 and 48 weeks,', 'description': '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'}, {'measure': 'Proportion (in %) of the 24 APA sessions carried out (at least 80% of the exercises proposed) in the different groups', 'timeFrame': 'week 48'}, {'measure': 'ClinESSDAI score', 'timeFrame': 'at 12, 24 and 48 weeks,', 'description': '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'}, {'measure': "ESSPRI questionnaire (EULAR Sjögren's Syndrome Patient Reported Index)", 'timeFrame': 'at 12, 24 and 48 weeks', 'description': "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"}, {'measure': 'HADS questionnaire (Hospital Anxiety and Depression Scale)', 'timeFrame': 'at 12, 24 and 48 weeks', 'description': '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'}, {'measure': 'Self-measurement questionnaire SF-36 (Short Form Health Survey 36)', 'timeFrame': 'between inclusion (Week 0) and week 48', 'description': '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)'}, {'measure': 'EQ-5D-5L self-measurement questionnaire assessing 5 dimensions of health', 'timeFrame': 'at 12, 24, and 48 weeks,', 'description': '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'}, {'measure': 'Schirmer test', 'timeFrame': 'at 12, 24 and 48 weeks', 'description': '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'}, {'measure': 'VO2max', 'timeFrame': 'at 12, 24 and 48 weeks', 'description': 'VO2max (in ml/min/kg; after metabolic test) in the different groups'}, {'measure': 'Handgrip test', 'timeFrame': 'at 12, 24 and 48 weeks', 'description': 'Handgrip test (in kg; via a grip test on the dominant upper limb) in the different groups'}, {'measure': 'Number of daily steps', 'timeFrame': 'at 12, 24 and 48 weeks', 'description': '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'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ["Sjögren's Syndrome", 'fatigue', 'acupuncture', 'adapted physical activity (APA)', 'transcutaneous vagal nerve stimulation (tVNS)'], 'conditions': ['Sjogren Syndrome']}, 'referencesModule': {'references': [{'pmid': '40546749', 'type': 'DERIVED', 'citation': "Zhou X, Chen J, Colas C, Hupin D, Killian M. FatiguE in Sjogren's Syndrome: a randomised controlled trial of cOmbined Non-phArmacological therapeutic strategies (FESSONA). BMJ Open Sport Exerc Med. 2025 Jun 16;11(2):e002677. doi: 10.1136/bmjsem-2025-002677. eCollection 2025."}]}, 'descriptionModule': {'briefSummary': "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.\n\nFESSONA 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).\n\nMultiple 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patient affiliated or entitled to a social security scheme.\n* Age \\> 18 years.\n* Patient informed and having signed the information form and consent to participate in the study.\n* Patient with Sjögren's syndrome according to ACR/EULAR 2016 or AECG 2002 criteria, usually followed up every year or more frequently\n* 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\n\nExclusion Criteria:\n\n* Pre-existing atrial fibrillation or severe cardiac conduction disorders,\n* Recent stroke or myocardial infarction (\\<6 months),\n* Left ventricular ejection fraction \\<40% or severe heart failure (New York Heart Association functional class III or IV)\n* Recurrent episodes of vasovagal syncope, or history of vagotomy\n* People with dermatological problems in the area where the stimulation electrodes are to be placed\n* Current episode of venous or arterial thrombosis\n* Pregnancy or breastfeeding\n* Patient under protective measures (legal protection, curatorship, guardianship)\n* 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"}, 'identificationModule': {'nctId': 'NCT06875102', 'acronym': 'FESSONA', 'briefTitle': "Fatigue in Sjögren's Syndrome: 3 Therapeutic Strategies", 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Saint Etienne'}, 'officialTitle': "Fatigue in Sjögren's Syndrome: a Randomized Controlled Trial of Combined Non-pharmacological Therapeutic Strategies", 'orgStudyIdInfo': {'id': '24CH125'}, 'secondaryIdInfos': [{'id': 'ANSM', 'type': 'OTHER', 'domain': '2024-A02116-41'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'APA + sham ACU + tVNS', 'interventionNames': ['Device: Transcutaneous Vagus Nerve Stimulation (tVNS)', 'Other: APA (adapted physical activity )', 'Device: Acupuncture (sham_ACU)']}, {'type': 'EXPERIMENTAL', 'label': 'APA + ACU + simulated tVNS', 'interventionNames': ['Device: Acupuncture (ACU)', 'Other: APA (adapted physical activity )', 'Device: Simulated Transcutaneous Vagus Nerve Stimulation (sim_tVNS)']}, {'type': 'SHAM_COMPARATOR', 'label': 'APA + Simulated tVNS + sham ACU', 'interventionNames': ['Other: APA (adapted physical activity )', 'Device: Acupuncture (sham_ACU)', 'Device: Simulated Transcutaneous Vagus Nerve Stimulation (sim_tVNS)']}], 'interventions': [{'name': 'Acupuncture (ACU)', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['APA + ACU + simulated tVNS']}, {'name': 'Transcutaneous Vagus Nerve Stimulation (tVNS)', 'type': 'DEVICE', 'description': '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.\n\nStimulation 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).', 'armGroupLabels': ['APA + sham ACU + tVNS']}, {'name': 'APA (adapted physical activity )', 'type': 'OTHER', 'description': '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', 'armGroupLabels': ['APA + ACU + simulated tVNS', 'APA + Simulated tVNS + sham ACU', 'APA + sham ACU + tVNS']}, {'name': 'Acupuncture (sham_ACU)', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['APA + Simulated tVNS + sham ACU', 'APA + sham ACU + tVNS']}, {'name': 'Simulated Transcutaneous Vagus Nerve Stimulation (sim_tVNS)', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['APA + ACU + simulated tVNS', 'APA + Simulated tVNS + sham ACU']}]}, 'contactsLocationsModule': {'locations': [{'zip': '42055', 'city': 'Saint-Etienne', 'country': 'France', 'contacts': [{'name': 'Martin KILLIAN, MD', 'role': 'CONTACT', 'email': 'martin.killian@chu-st-etienne.fr', 'phone': '(33) 4 77 82 91 79', 'phoneExt': '+33'}, {'name': 'Florence RANCON, Chef de projet', 'role': 'CONTACT', 'email': 'florence.rancon@chu-st-etienne.fr', 'phone': '(33) 4 77 82 94 58', 'phoneExt': '+33'}, {'name': 'David HUPIN, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Hubert MAROTTE, MD PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Lucile GRANGE, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Baptiste GRAMONT, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Chu de Saint-Etienne', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}], 'centralContacts': [{'name': 'Martin KILLIAN, MD', 'role': 'CONTACT', 'email': 'martin.killian@chu-st-etienne.fr', 'phone': '(33)477 82 91 79', 'phoneExt': '+33'}, {'name': 'Florence RANCON, Chef de projet', 'role': 'CONTACT', 'email': 'florence.rancon@chu-st-etienne.fr', 'phone': '(33)477829458', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'Martin KILLIAN, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Saint Etienne', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}