NCT03785847已完成不适用
Normal Variability of Tidal Breathing Flow-volume Curves During Sleep in Healthy Children
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Ventica measurement
研究概览
简要总结
The study includes a comprehensive health examination with focus on respiratory health and the TBFV recordings using impedance pneumography (Ventica®) during sleep at night in healthy children.
详细描述
Impedance pneumograpy results in healthy children to generate normal values and to stude the effect of age and gender
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 12 Months 至 71 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 12 months-71 months, both sexes
- •Healthy at the time of inclusion
- •Signed informed consent
排除标准
- •Preterm birth
- •Recurrent bronchitis or recurrent hospitalizations because of a respiratory illness
- •Nasal congestion, adenotonsillar hypertrophy, signs and symptoms of sleep apnea or sleep disordered breathing
- •Acute respiratory infection or hospitalization because of an acute illness within 4 weeks prior to inclusion
- •Personal or family history of asthma
- •Recurrent wheezing without respiratory infection
- •Allergic rhinitis, chronic rhinosinusitis, or other chronic respiratory disorders
- •Atopic dermatitis
- •Diagnosed allergic sensitization
- •Use of asthma rescue or maintenance medication within 4 weeks prior to inclusion
- •Any major chronic illness as judged by the investigators
- •Implanted or external active medical devices such as pacemakers
结局指标
主要结局
Ventica measurement
时间窗: overnight measurement
level of overnight tidal breathing flow volume variation
次要结局
未报告次要终点
研究者
Jussi Karjalainen
Head of Department, MD, PhD
Tampere University Hospital
研究点 (1)
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