Interest of Thermal Spa Treatment in Improving ENT-Related Quality of Life in Patients With Primary Ciliary Dyskinesia

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
Institut Universitaire de la Face et du Cou
RECRUITING
Nice
Contact Information
Primary
Colin DEBAIGT
colin.debaigt@nice.unicancer.fr
+33492031661
Time Frame
Start Date: 2025-09-05
Estimated Completion Date: 2027-05-05
Participants
Target number of participants: 35
Treatments
Experimental: Groupe A
Group starting with thermal spa treatment
Experimental: Group B
Group starting with prophylactic treatment
Sponsors
Collaborators: Centre Antoine Lacassagne
Leads: Association Francaise pour la Recherche Thermale

This content was sourced from clinicaltrials.gov