Thermal Spa Treatment and Improvement of Primary Ciliary Dyskinesia

Launched by ASSOCIATION FRANCAISE POUR LA RECHERCHE THERMALE · Jun 12, 2025

Keywords

ClinConnect Summary

This clinical trial is studying whether a 3-week thermal spa treatment can help adults with Primary Ciliary Dyskinesia (PCD), a rare lung condition that causes ongoing ear, nose, and throat problems and frequent infections. The researchers want to see if this spa therapy can improve symptoms like nasal congestion and ear issues, reduce infections and the need for antibiotics, and possibly improve hearing and lung function. Participants will be divided into two groups: one group will have the spa treatment right away, while the other will receive usual care for six months before getting the spa treatment later.

To join the study, adults must have a confirmed diagnosis of PCD and be on stable treatment without recent worsening of their symptoms. During the trial, participants will have regular checkups, including hearing tests and breathing tests, and will visit a spa center for the treatment without needing to stay overnight in a hospital. The treatment is generally safe, but there is a small risk of mild flare-ups or new infections during the spa therapy. This study hopes to find out if spa treatment can help people with PCD feel better and have fewer infections, improving their overall quality of life.

Gender

ALL

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 lesions (wounds, pressure sores, eczema).
• • Contagious or progressive diseases.
• • Recent cancer (less than 5 years).
• • Ongoing or recent (within the past month) pulmonary or ENT exacerbation at inclusion.
• • Ongoing treatment with immunomodulatory or immunosuppressive drugs (due to the risk of potentially severe opportunistic infections).
• • Ongoing or recent (within the past month) extra-respiratory or ENT infectious flare-up.
• • Positive pre-cure bacteriological testing for multidrug-resistant Pseudomonas aeruginosa, MRSA, Mycobacterium abscessus, or other multidrug-resistant pathogenic bacteria.
• • Fever \> 38.5°C.
• • Recently worsened dyspnea (\< 1 month).
• • History of serious adverse effects or intolerance during a previous thermal spa treatment.
• • Participation in another clinical trial with an exclusion period.
• * Considered a vulnerable person, as defined by Articles L1121-5 to L1121-8 of the French Public Health Code:
• • Pregnant women, women in labor, and breastfeeding mothers.
• • Individuals 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.
• • Adults under legal protection or unable to give informed consent.