Thermal Spa Treatment and Improvement of Primary Ciliary Dyskinesia

NCT07029594 | Recruiting

• 1 other identifier: 2022/87
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Ciliary Dyskinesia

Outcome Measures

Primary Outcomes (1)

• Quality of life

  The primary objective of this study is to evaluate whether a thermal spa treatment leads to a significant improvement in quality of life, as well as in respiratory and auditory symptoms, in patients with primary ciliary dyskinesia. The primary outcome will be the improvement, after spa therapy, of a validated French-language ENT quality of life score specifically designed to assess functional complaints and quality of life in patients with conditions affecting the nasal passages.

  6 months

Study Arms (2)

Groupe A

EXPERIMENTAL

Group starting with thermal spa treatment

Other: balneotherapy

Group B

EXPERIMENTAL

Group starting with prophylactic treatment

Other: balneotherapy

Interventions

balneotherapy OTHER

Specific procedures performed during the 3-week spa therapy Thermal Treatments (Number of sessions) Individual nasal irrigation (18) Sonic aerosol therapy (18) Simple aerosol therapy (18) Individual inhalation therapy (18) Administered by a licensed physiotherapist Individual respiratory rehabilitation and bronchial drainage (18) Administered by a spa physician Tubo-tympanic insufflation (9) Sinus lavage using the Proëtz displacement method 9

Group B; Groupe A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Performance Status (PS) ≤ 1.
• Patient has received the study information sheet and signed the informed consent form.
• Patient has valid health insurance coverage.

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• Association Francaise pour la Recherche Thermale: lead
• Centre Antoine Lacassagne: collaborator

Study Sites (1)

Institut Universitaire de la Face et du Cou

Nice, 06103, France

RECRUITING

MeSH Terms

Conditions

Ciliary Motility Disorders

Interventions

Balneology

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Ciliopathies; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Colin DEBAIGT

CONTACT

+33492031661; colin.debaigt@nice.unicancer.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2025
• First Posted: June 19, 2025
• Study Start: September 5, 2025
• Primary Completion (Estimated): December 5, 2026
• Study Completion (Estimated): May 5, 2027
• Last Updated: June 19, 2025

Record last verified: 2025-06

Locations

FR (1)