Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Centre Antoine Lacassagne | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Groupe A | Experimental | Group starting with thermal spa treatment |
|
| Group B | Experimental | Group starting with prophylactic treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Pregnant women, women in labor, and breastfeeding mothers.
Individuals deprived of liberty by judicial or administrative decision, or those hospitalized without consent under Articles L.3212-1 and L.3213-1 (excluding Article L.1121-8), and persons admitted to a healthcare or social institution for reasons other than research.
Adults under legal protection or unable to give informed consent.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Colin DEBAIGT | Contact | +33492031661 | colin.debaigt@nice.unicancer.fr |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Universitaire de la Face et du Cou | Recruiting | Nice | 06103 | France |
Not provided
| ID | Term |
|---|---|
| D002925 | Ciliary Motility Disorders |
| ID | Term |
|---|---|
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D000072661 | Ciliopathies |
| D000015 | Abnormalities, Multiple |
Not provided
Not provided
| ID | Term |
|---|---|
| D001452 | Balneology |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D030342 | Genetic Diseases, Inborn |