NCT07029594 Thermal Spa Treatment and Improvement of Primary Ciliary Dyskinesia
| NCT ID | NCT07029594 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Association Francaise pour la Recherche Thermale |
| Condition | Primary Ciliary Dyskinesia |
| Study Type | INTERVENTIONAL |
| Enrollment | 35 participants |
| Start Date | 2025-09-05 |
| Primary Completion | 2026-12-05 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
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. The main questions the study aims to answer are: Does spa therapy improve ENT-related symptoms and daily quality of life? Does it help reduce the frequency of infections and the need for antibiotics? Are there improvements in hearing and lung function? In this study, participants will be randomly assigned to one of two groups: Group A will begin with a 3-week spa treatment, followed by regular checkups for 6 months. Group B will start with standard care for 6 months, then receive the spa treatment and follow-up evaluations for another 6 months. All participants will: Undergo ENT and lung function evaluations (questionnaires, hearing tests, nasal swabs, spirometry) Visit one of two spa centers for a 3-week treatment period (without hospital stay) Be followed regularly over several months for checkups and tests Researchers will compare participants' symptoms and test results before and after the spa treatment to determine its benefits. Potential benefits: Participants may experience relief from nasal symptoms, fewer respiratory infections, improved hearing and breathing, and an overall better quality of life. Potential risks: There 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.
Eligibility Criteria
Inclusion Criteria: * 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). * Age over 18 years. * Stable maintenance treatment for at least 1 month prior to inclusion. * Performance Status (PS) ≤ 1. * Patient has received the study information sheet and signed the informed consent form. * Patient has valid health insurance coverage. Exclusion Criteria: * Participation in a thermal spa treatment within the past year. * Severe general health deterioration or debilitating conditions. * Severe or recent heart failure. * Labile hypertension. * Venous insufficiency or deep vein thrombosis within the past 3 months. * Recent unhealed fracture. * Unhealed skin le