Thermal Spa Treatment and Improvement of Primary Ciliary Dyskinesia

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssociation Francaise pour la Recherche Thermale

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

Participation in a thermal spa treatment within the past year.

Severe general health deterioration or debilitating conditions.

Severe or recent heart failure.

Labile hypertension.

Trial design

Treatments tested in this trial

  • balneotherapy

Treatment groups

35 Participants
are divided into 2 treatment groups

Sponsors and collaborators