Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07029594

Thermal Spa Treatment and Improvement of Primary Ciliary Dyskinesia

Led by Association Francaise pour la Recherche Thermale · Updated on 2025-06-19

35

Participants Needed

1

Research Sites

86 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

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

Official Title

Thermal Spa Treatment and Improvement of Primary Ciliary Dyskinesia

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Confirmed diagnosis of Primary Ciliary Dyskinesia using 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
Not Eligible

You will not qualify if you...

  • 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 in the past 3 months
  • Recent unhealed fracture
  • Unhealed skin lesions such as wounds, pressure sores, or eczema
  • Contagious or progressive diseases
  • Cancer within the last 5 years
  • Pulmonary or ENT symptom flare-up within the past month
  • Treatment with immunomodulatory or immunosuppressive drugs
  • Extra-respiratory or ENT infectious flare-up within the past month
  • Positive test for multidrug-resistant bacteria such as Pseudomonas aeruginosa, MRSA, or Mycobacterium abscessus
  • Fever over 38.5 degrees Celsius
  • Recently worsened difficulty breathing within the last month
  • History of serious side effects or intolerance to previous thermal spa treatment
  • Participation in another clinical trial with exclusion period
  • Considered vulnerable persons including pregnant or breastfeeding women, individuals deprived of liberty, or adults under legal protection unable to consent

AI-Screening

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Trial Site Locations

Total: 1 location

1

Institut Universitaire de la Face et du Cou

Nice, France, 06103

Actively Recruiting

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Research Team

C

Colin DEBAIGT

CONTACT

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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