Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:31 AM
Ignite Modification Date:
2025-12-25 @ 1:31 AM
NCT ID:
NCT07029594
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07029594
Study Brief:
Protocol Section:
NCT07029594