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Thermal Spa Treatment and Improvement of Primary Ciliary Dyskinesia

NCT07029594 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2025-06-19

No results posted yet for this study

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

Interventions

OTHER

balneotherapy

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

Sponsors & Collaborators

  • Centre Antoine Lacassagne

    collaborator OTHER

  • Association Francaise pour la Recherche Thermale

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-05
Primary Completion
2026-12-05
Completion
2027-05-05

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07029594 on ClinicalTrials.gov