Home Telemonitoring of Resting Spontaneous Breathing in Severe Asthma: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 4
- 主要终点
- Positive predictive value of resting breath parameters to predict asthma exacerbation
研究概览
简要总结
Asthma exacerbations account for a significant morbidity and disproportionate health care costs. However, there is no currently available biomarker or lung function parameter that can accurately predict the risk of future exacerbations. The current work aims at evaluating the resting ventilatory flow by applying a new technique called anharmonic morphological analysis of the respiratory signals (AMARS). We hypothesize that monitoring AMARS is potentially able to detect an increased risk of asthma exacerbations.
详细描述
Asthma exacerbations represent an acute or sub-acute worsening in symptoms and lung function from the patient's usual status. Early detection of exacerbations is a major public health issue. In clinic, management of asthma involves asthma control questionnaires and pulmonary function tests (Forced Expiratory Volume (FEV1), Fractional exhaled nitric oxide or FeNO). At home, the peak expiratory flow rate (PEFR) measured by the peak flow meter is an aid to monitor asthma but its ability to predict asthma exacerbations remains controversial. Anharmonic morphological analysis of the respiratory signals (AMARS) is a new morpho-mathematic biomarker that produces objective and accurate measures of the shape of the ventilatory flow. The current study aims at monitoring the resting spontaneous breathing at home in asthmatics. Changes in AMARS may be a predictor of early symptoms of asthma exacerbations. We will recruit 120 asthmatic patients. Patients will be given a portable device for telemonitoring. Resting spontaneous breathing will be measured during 2-3 min in the morning and in the evening, twice a week at least for 12 months. Three visits will be scheduled in Clinical Investigation Center before (V1), after 6-month (V2) and 12-month (V3) telemonitoring period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 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
- •male or female aged more than 18 yrs
- •written informed consent
- •diagnosis of asthma according to Global Initiative For Asthma (GINA) criteria
- •history of at least one moderate to severe exacerbation in the previous 12 months
排除标准
- •smoker or former smoker (> 10 packs-year)
- •concomitant asthma exacerbation (at V1)
- •prisoners
- •protected adults
- •no affiliation to the French Social Security System
研究组 & 干预措施
AMARS
Evaluation the resting ventilatory flow by applying a new technique called anharmonic morphological analysis of the respiratory signals (AMARS).
干预措施: anharmonic morphological analysis of the respiratory signals (AMARS) (Device)
结局指标
主要结局
Positive predictive value of resting breath parameters to predict asthma exacerbation
时间窗: 12 months
Sensibility parameters resting breath parameter to predict asthma exacerbation
时间窗: 12 months
Specificity of resting breath parameters to predict asthma exacerbation
时间窗: 12 months
Negative predictive value of resting breath parameters to predict asthma exacerbation
时间窗: 12 months
次要结局
- Forced Vital Capacity (FVC)(day 1)
- Asthma exacerbation severity(12 months)
- PEF(12 months)
- Asthma quality of life questionnaires(12 months)
- Asthma Control Test questionnaires(12 months)
- FEV1/FVC ratio(12 months)
- FEV1(12 months)
- FVC(12 months)
- Forced Expiratory Flow (FEF25-75%)(Day 1)
- FEF25-75%(12 months)