Actively Recruiting
Interest of Thermal Spa Treatment in Improving ENT-Related Quality of Life in Patients With Primary Ciliary Dyskinesia
Led by Association Francaise pour la Recherche Thermale · Updated on 2025-06-19
35
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
Sponsors
A
Association Francaise pour la Recherche Thermale
Lead Sponsor
C
Centre Antoine Lacassagne
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating whether a 3-week thermal spa treatment can improve quality of life and reduce ear, nose, and throat (ENT) symptoms in adults with Primary Ciliary Dyskinesia (PCD), a rare chronic condition causing persistent sinus, ear, and lung infections. The study aims to find out if spa therapy can ease ENT symptoms, lower infection rates, reduce antibiotic use, and improve hearing and lung function. Participants will be randomly assigned to one of two groups. Group A will receive the 3-week spa treatment first, followed by regular checkups over 6 months. Group B will begin with standard care for 6 months and then receive the spa treatment with additional follow-up for another 6 months. The spa therapy includes treatments like nasal irrigation, aerosol therapy, inhalation therapy, respiratory rehabilitation, and sinus lavage, all administered by trained professionals at specialized centers without hospital stay. Throughout the study, participants will undergo ENT and lung function assessments using questionnaires, hearing tests, nasal swabs, and spirometry. They will have regular visits for evaluations before and after the spa treatment to monitor symptoms and test results. The main measure is quality of life at 6 months. Researchers will watch for any mild flare-ups or infections during therapy. The total participation involves follow-up over many months to understand the effects of the spa treatment.
CONDITIONS
Brief Title
Thermal Spa Treatment and Improvement of Primary Ciliary Dyskinesia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of Primary Ciliary Dyskinesia based on electron microscopy or genetic testing
- Age over 18 years
- Stable maintenance treatment for at least 1 month before joining
- Performance Status of 1 or less
- Received study information and signed informed consent
- Valid health insurance coverage
You will not qualify if you...
- Thermal spa treatment received 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 fractures
- Unhealed skin lesions such as wounds, pressure sores, or eczema
- Contagious or progressive diseases
- Cancer diagnosed within the last 5 years
- Pulmonary or ENT exacerbation ongoing or in the past month
- Treatment with immunomodulatory or immunosuppressive drugs
- Extra-respiratory or ENT infectious flare-up ongoing or recent
- Positive tests for multidrug-resistant bacteria
- Fever higher than 38.5°C
- Recently worsened shortness of breath (less than 1 month)
- History of serious side effects or intolerance to previous thermal spa treatments
- Participation in another clinical trial with exclusion period
- Vulnerable persons as defined by French Public Health Code, including pregnant or breastfeeding women, persons deprived of liberty, or adults under legal protection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 weeks
Participants receive thermal spa treatment including nasal irrigation, aerosol therapies, respiratory rehabilitation, and other procedures administered over 3 weeks by licensed professionals.
Multiple visits during the 3-week spa therapy
Trial Site Locations
Total: 1 location
1
Institut Universitaire de la Face et du Cou
Nice, France, 06103
Actively Recruiting
Research Team
C
Colin DEBAIGT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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