Effect of the Nasal Provocation on the Breathing Style and on the Calibration of Respiratory Effort Belts
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- breathing style
研究概览
简要总结
The purpose of this study is to find out how the provocation of the nose changes breathing style (specifically, frequency and tidal volume changes)
详细描述
It is intended to clarify on both healthy and birch pollen allergic adults how the provocation of the nose with the birch pollen, dilutant and xylometazoline affect the breathing style (breathing pattern) and how these possible changes could be controlled in the measurement of the breathing with respiratory effort belts. In addition to this, our intention is to clarify the effect of the facial mask on the breathing.
The allergic and control subjects undergo nasal provocation in 2 sessions. The first is done with birch pollen extract (should block the nose in allergic subjects) and the second with xylometazoline (should open the nose).
The mask group undergo similar measurements without nasal exposures.
The second objective of the study is to clarify if there are differences between the allergic and control subjects in the function of the autonomous nervous system during these provocations. This is done with the heart rate variability analysis method.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Birch pollen allergic subjects must have clear nasal symptoms during the birch pollen season and birch specific IgE >= 0.70
- •Healthy subjects: birch specific IgE < 0.35
- •The subjects are not allowed to be under medication that affects the function of their nose during a specific time period before the measurement
- •They have to be free of any acute respiratory symptoms during the prior two weeks to the measurements
- •Before measurement, they are not allowed to have heavy meal or sport
- •They are not allowed to have caffeine or other stimulants for 12 hours or alcohol for 24 hours.
排除标准
- •Heart diseases
- •Brain circulatory disorders
- •Surgical operations of nose
- •Chronic nasal symptoms
- •Pregnancy
研究组 & 干预措施
Allergen and xylometatsolin
Two separate exposure sessions: 1) nasal birch pollen exposure 2) nasal xylometazoline exposure
干预措施: 1. session birch pollen nasal exposure 2. session xylometazoline nasal exposure (Biological)
结局指标
主要结局
breathing style
时间窗: continuously during 2 hours
frequence and volume of breathing measured with spirometry and respiratory effort belts
次要结局
- thorax - abdomen relation(continuously during 2 hours)
- activation of the autonomous nervous system(continuously during 2 hours)