Ignite Creation Date:
2025-12-25 @ 1:31 AM
Ignite Modification Date:
2025-12-27 @ 11:28 PM
Study NCT ID:
NCT07029594
Status:
RECRUITING
Last Update Posted:
2025-06-19
First Post:
2025-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Thermal Spa Treatment and Improvement of Primary Ciliary Dyskinesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002925', 'term': 'Ciliary Motility Disorders'}], 'ancestors': [{'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D000072661', 'term': 'Ciliopathies'}, {'id': 'D000015', 'term': 'Abnormalities, Multiple'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001452', 'term': 'Balneology'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 35}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-09-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2027-05-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-12', 'studyFirstSubmitDate': '2025-06-12', 'studyFirstSubmitQcDate': '2025-06-12', 'lastUpdatePostDateStruct': {'date': '2025-06-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of life', 'timeFrame': '6 months', 'description': 'The primary objective of this study is to evaluate whether a thermal spa treatment leads to a significant improvement in quality of life, as well as in respiratory and auditory symptoms, in patients with primary ciliary dyskinesia. The primary outcome will be the improvement, after spa therapy, of a validated French-language ENT quality of life score specifically designed to assess functional complaints and quality of life in patients with conditions affecting the nasal passages.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Primary Ciliary Dyskinesia']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to evaluate whether a 3-week thermal spa treatment can improve quality of life and reduce ENT (ear, nose, and throat) symptoms in adults with Primary Ciliary Dyskinesia (PCD). PCD is a rare, chronic condition that affects the airways and often leads to persistent sinus, ear, and lung infections.\n\nThe main questions the study aims to answer are:\n\nDoes spa therapy improve ENT-related symptoms and daily quality of life?\n\nDoes it help reduce the frequency of infections and the need for antibiotics?\n\nAre there improvements in hearing and lung function?\n\nIn this study, participants will be randomly assigned to one of two groups:\n\nGroup A will begin with a 3-week spa treatment, followed by regular checkups for 6 months.\n\nGroup B will start with standard care for 6 months, then receive the spa treatment and follow-up evaluations for another 6 months.\n\nAll participants will:\n\nUndergo ENT and lung function evaluations (questionnaires, hearing tests, nasal swabs, spirometry)\n\nVisit one of two spa centers for a 3-week treatment period (without hospital stay)\n\nBe followed regularly over several months for checkups and tests\n\nResearchers will compare participants\' symptoms and test results before and after the spa treatment to determine its benefits.\n\nPotential benefits:\n\nParticipants may experience relief from nasal symptoms, fewer respiratory infections, improved hearing and breathing, and an overall better quality of life.\n\nPotential risks:\n\nThere is a small risk of infection from a new germ or a mild, short-term flare-up of chronic symptoms (called a "thermal reaction") that can occur during spa therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed diagnosis of Primary Ciliary Dyskinesia (PCD) based on electron microscopy analysis of ciliary ultrastructure and/or genetic testing (i.e., two unambiguous mutations in genes known to be involved in PCD, particularly in cases with normal ciliary ultrastructure \\[\\~20% of patients\\], atypical ultrastructural findings, or suggestive symptoms in a family with a known causal gene).\n* Age over 18 years.\n* Stable maintenance treatment for at least 1 month prior to inclusion.\n* Performance Status (PS) ≤ 1.\n* Patient has received the study information sheet and signed the informed consent form.\n* Patient has valid health insurance coverage.\n\nExclusion Criteria:\n\n* Participation in a thermal spa treatment within the past year.\n* Severe general health deterioration or debilitating conditions.\n* Severe or recent heart failure.\n* Labile hypertension.\n* Venous insufficiency or deep vein thrombosis within the past 3 months.\n* Recent unhealed fracture.\n* Unhealed skin lesions (wounds, pressure sores, eczema).\n* Contagious or progressive diseases.\n* Recent cancer (less than 5 years).\n* Ongoing or recent (within the past month) pulmonary or ENT exacerbation at inclusion.\n* Ongoing treatment with immunomodulatory or immunosuppressive drugs (due to the risk of potentially severe opportunistic infections).\n* Ongoing or recent (within the past month) extra-respiratory or ENT infectious flare-up.\n* Positive pre-cure bacteriological testing for multidrug-resistant Pseudomonas aeruginosa, MRSA, Mycobacterium abscessus, or other multidrug-resistant pathogenic bacteria.\n* Fever \\> 38.5°C.\n* Recently worsened dyspnea (\\< 1 month).\n* History of serious adverse effects or intolerance during a previous thermal spa treatment.\n* Participation in another clinical trial with an exclusion period.\n* Considered a vulnerable person, as defined by Articles L1121-5 to L1121-8 of the French Public Health Code:\n\nPregnant women, women in labor, and breastfeeding mothers.\n\nIndividuals deprived of liberty by judicial or administrative decision, or those hospitalized without consent under Articles L.3212-1 and L.3213-1 (excluding Article L.1121-8), and persons admitted to a healthcare or social institution for reasons other than research.\n\nAdults under legal protection or unable to give informed consent.'}, 'identificationModule': {'nctId': 'NCT07029594', 'acronym': 'CANDY', 'briefTitle': 'Thermal Spa Treatment and Improvement of Primary Ciliary Dyskinesia', 'organization': {'class': 'OTHER', 'fullName': 'Association Francaise pour la Recherche Thermale'}, 'officialTitle': 'Interest of Thermal Spa Treatment in Improving ENT-Related Quality of Life in Patients With Primary Ciliary Dyskinesia', 'orgStudyIdInfo': {'id': '2022/87'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Groupe A', 'description': 'Group starting with thermal spa treatment', 'interventionNames': ['Other: balneotherapy']}, {'type': 'EXPERIMENTAL', 'label': 'Group B', 'description': 'Group starting with prophylactic treatment', 'interventionNames': ['Other: balneotherapy']}], 'interventions': [{'name': 'balneotherapy', 'type': 'OTHER', 'description': 'Specific procedures performed during the 3-week spa therapy\n\nThermal Treatments (Number of sessions)\n\nIndividual nasal irrigation (18) Sonic aerosol therapy (18) Simple aerosol therapy (18) Individual inhalation therapy (18)\n\nAdministered by a licensed physiotherapist\n\nIndividual respiratory rehabilitation and bronchial drainage (18)\n\nAdministered by a spa physician Tubo-tympanic insufflation (9) Sinus lavage using the Proëtz displacement method 9', 'armGroupLabels': ['Group B', 'Groupe A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06103', 'city': 'Nice', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Clair Vandersteen', 'role': 'CONTACT', 'email': 'vandersteen.c@chu-nice.fr', 'phone': '+33492031705'}], 'facility': 'Institut Universitaire de la Face et du Cou', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}], 'centralContacts': [{'name': 'Colin DEBAIGT', 'role': 'CONTACT', 'email': 'colin.debaigt@nice.unicancer.fr', 'phone': '+33492031661'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Association Francaise pour la Recherche Thermale', 'class': 'OTHER'}, 'collaborators': [{'name': 'Centre Antoine Lacassagne', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}