Interest of Thermal Spa Treatment in Improving ENT-Related Quality of Life in Patients With Primary Ciliary Dyskinesia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Quality of life
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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) ≤
- •Patient has received the study information sheet and signed the informed consent form.
- •Patient has valid health insurance coverage.
排除标准
- •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.
- •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.
研究组 & 干预措施
Group B
Group starting with prophylactic treatment
干预措施: balneotherapy (Other)
Groupe A
Group starting with thermal spa treatment
干预措施: balneotherapy (Other)
结局指标
主要结局
Quality of life
时间窗: 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.
次要结局
未报告次要终点