Primary Ciliary DyskinesiaCANDYNCT07029594
Thermal Spa Treatment and Improvement of Primary Ciliary Dyskinesia
A study testing balneotherapy in people with Primary Ciliary Dyskinesia, run by Association Francaise pour la Recherche Thermale at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Ciliary Dyskinesia
- What is being tested?
- balneotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteFrance
- Study dates
- 5 Sep 2025to 5 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Patient has received the study information sheet and signed the informed consent form.
- Patient has valid health insurance coverage.
Who cannot join
- 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.
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- Unhealed skin lesions (wounds, pressure sores, eczema).
- Contagious or progressive diseases.
- Recent cancer (less than 5 years).
- Ongoing or recent (within the past month) pulmonary or ENT exacerbation at inclusion.
- 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.
- Participation in another clinical trial with an exclusion period.
- Considered a vulnerable person, as defined by Articles L1121-5 to L1121-8 of the French Public Health Code:
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Institut Universitaire de la Face et du Cou
Nice, 06103
Clair Vandersteen, +33492031705, vandersteen.c@chu-nice.fr
About this study
Official title: Interest of Thermal Spa Treatment in Improving ENT-Related Quality of Life in Patients With Primary Ciliary Dyskinesia
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:
Read more
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
- Being tested
- balneotherapy
- Medical subject headings
- Ciliary Motility Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
balneotherapyOther
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
| Study group | Role | What they receive |
|---|---|---|
| Groupe A | Experimental | Group starting with thermal spa treatment Receives: Other: balneotherapy |
| Group B | Experimental | Group starting with prophylactic treatment Receives: Other: balneotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2025
- Study start5 Sep 2025 (estimated)
- Primary completion5 Dec 2026 (estimated)
- Study completion5 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Ciliary DyskinesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Association Francaise pour la Recherche Thermale
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Antoine Lacassagne
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07029594
- Sponsor's protocol ID
- 2022/87
- Acronym
- CANDY
- Status last verified
- Jun 2025
- First submitted
- 12 Jun 2025
- Last updated
- 19 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Thermal Spa Treatment in Improving ENT-Related Quality of Life in Patients With Primary Ciliary Dyskinesia
- ClinicalTrials.gov ID
- NCT07029594
- Acronym / sponsor ID
- CANDY / 2022/87
- Conditions
- Primary Ciliary Dyskinesia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Association Francaise pour la Recherche ThermaleUniversity, hospital or other
- Collaborators
- Centre Antoine Lacassagne
- Study start
- 5 Sep 2025 (estimated)
- Primary completion
- 5 Dec 2026 (estimated)
- Study completion
- 5 May 2027 (estimated)
- First posted
- 19 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Groupe A | Experimental | Other: balneotherapyGroup starting with thermal spa treatment |
| Group B | Experimental | Other: balneotherapyGroup starting with prophylactic treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
- Patient has received the study information sheet and signed the informed consent form.
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| balneotherapySpecific 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 | Other | Group B, Groupe A |
Primary outcome
Quality of life
Time frame: 6 months
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing balneotherapy in people with Primary Ciliary Dyskinesia, run by Association Francaise pour la Recherche Thermale at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Colin DEBAIGT (+33492031661, colin.debaigt@nice.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2025.