Ignite Creation Date:
2025-12-25 @ 1:31 AM
Ignite Modification Date:
2025-12-27 @ 11:28 PM
Study NCT ID:
NCT07029594
Status:
RECRUITING
Last Update Posted:
2025-06-19
First Post:
2025-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Thermal Spa Treatment and Improvement of Primary Ciliary Dyskinesia
Sponsor:
Association Francaise pour la Recherche Thermale
Organization:
Study Overview
Official Title:
Interest of Thermal Spa Treatment in Improving ENT-Related Quality of Life in Patients With Primary Ciliary Dyskinesia
Status:
RECRUITING
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CANDY
Brief 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: