NCT03408990已完成不适用
Confounding Factors of Impedance Pneumography Signal Changes During Sleep
Revenio Research1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2018年1月26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
- 20
- 试验地点
- 1
- 主要终点
- Association between sleep stages and tidal breathing flow-volume (TBFV) curves
研究概览
简要总结
The purpose of this study is to evaluate the association of signals recorded and analysed with Ventica® Lung Function Testing System (LFTS) in infants and pre-schoolers during the whole night sleep with the gold standard for sleep recording events, polysomnography, in order to better understand the confounding factors for momentary changes in the impedance pneumography-derived tidal breathing flow-volume (TBFV) curves.
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
- 1 Year 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Preterm birth with chronic respiratory disorder of prematurity
- •Significant nasal congestion or adenotonsillar hypertrophy with signs and symptoms of sleep apnea or sleep disordered breathing
- •Chronic rhinosinusitis, synonasal polyposis
- •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
- •Recurrent bronchitis or recurrent hospitalizations because of a respiratory illness (recurrent pneumonia)
- •Hospital-treated for bronchiolitis with residual symptoms
- •Acute respiratory infection or hospitalization because of an acute illness within 4 weeks prior to inclusion
- •Other cardiorespiratory or neurological chronic diseases or states that may significantly alter the overnight breathing pattern
- •Implanted or external active medical devices
- •Long lasting respiratory events during the polysomnography study like continuous upper airway limitation
结局指标
主要结局
Association between sleep stages and tidal breathing flow-volume (TBFV) curves
时间窗: 1 night
Assess the correlation between Ventica-derived TBFV curves within and between different EEG-derived sleep stages during night sleep
次要结局
- Association between body/head positions and tidal breathing flow-volume (TBFV) curves(1 night)
研究者
研究点 (1)
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