NCT03551236已完成不适用
Variability of Impedance Pneumography Tidal Breathing Flow-volume Curves During Sleep in Healthy Children
Revenio Research1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2017年1月17日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Normal range of variables of tidal breathing flow-volume curves (CSRmin, NLmin, etc.)
研究概览
简要总结
This is an observational study for the assessment of normal overnight variation in small healthy children using the Ventica Lung Function Testing System. The study is carried out to establish reference ranges for overnight lung function variation using the Ventica test, and to assess the impact of the demographic factors on the Ventica results.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 接受健康志愿者
- 否
入选标准
- •18 months-6 years, both sexes
- •Healthy at the time of inclusion
- •Laboratory analyses in the reference range or not clinically relevant according to the investigator judgement
- •Lung function in the reference range with a negative bronchodilator test result
- •Signed informed consent
排除标准
- •Preterm birth
- •Chronic respiratory disorder of prematurity
- •Recurrent bronchitis or recurrent hospitalizations because of a respiratory illness (recurrent pneumonia)
- •Primary immunodeficiency
- •Chronic rhinosinusitis, synonasal polyposis
- •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 or clinical evidence of asthma, atopy or other chronic respiratory disorders (high risk for asthma and allergy)
- •Use of asthma rescue or maintenance medication within 4 weeks prior to inclusion
- •Implanted or external active medical devices such as pacemakers
结局指标
主要结局
Normal range of variables of tidal breathing flow-volume curves (CSRmin, NLmin, etc.)
时间窗: 1-3 nights per subject
Analyse the normal range of variables that describe the shape and variability of tidal breathing flow-volume curves during natural night sleep obtained with impedance pneumography
次要结局
未报告次要终点
研究者
研究点 (1)
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