Change in Breathing During Hospital Admission for COPD Exacerbation
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Nocturnal ventilatory variability during sleep assessed by polysomnography
研究概览
简要总结
hronic obstructive pulmonary disease (COPD) is a common lung disease that can worsen suddenly, leading to hospital admission. During these exacerbations, breathing becomes unstable and recovery is difficult to predict. Currently, doctors lack simple tools to monitor how patients recover day by day during hospitalization and after discharge.
This observational study aims to describe how breathing patterns during sleep change over time in patients hospitalized for a COPD exacerbation. Breathing will be monitored using standard sleep recordings and a non-contact sensor placed under the mattress, which measures breathing without disturbing the patient.
By better understanding how nocturnal breathing variability evolves during recovery, this study may help identify early signs of improvement or deterioration, support safer hospital discharge decisions, and improve follow-up after hospitalization for COPD exacerbation
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Adults (≥ 18 years) with a confirmed diagnosis of chronic obstructive pulmonary disease (COPD) based on spirometry
- •Hospitalized for an acute exacerbation of COPD for less than 24 hours at the time of inclusion
- •Admitted to an acute medical ward
- •Able to provide written informed consent
- •Affiliated with the national health insurance system
排除标准
- •Ongoing invasive or non-invasive mechanical ventilation at the time of inclusion
- •Long-term non-invasive ventilation or positive airway pressure therapy prior to hospitalization
- •Use of an anti-pressure (anti-decubitus) mattress incompatible with the study devices
- •Severe anxiety disorders interfering with study procedures
- •Known allergy to materials used for sensor placement
- •Pregnancy or breastfeeding
- •Minor or legally protected adult (guardianship, curatorship) or deprivation of liberty
- •Lack of health insurance coverage
研究组 & 干预措施
COPD acute exacerbations
Consecutive patients admitted in a medicine hospital department for acute exacerbation of COPD
结局指标
主要结局
Nocturnal ventilatory variability during sleep assessed by polysomnography
时间窗: Baseline (first night after hospitalization), Day 3 of hospitalization, Day 7 of hospitalization or the day before discharge (if discharge occurs earlier), and 6 weeks after hospital discharge (study completion)
Nocturnal ventilatory variability will be quantified during sleep using polysomnography. Variability will be assessed on a breath-by-breath basis using 30-second analysis windows and summarized by the following predefined indice SD. SD will be calculated separately for each sleep stage (N1, N2, N3, REM) and then averaged across total sleep time for each recording night.
次要结局
- Nocturnal ventilatory variability assessed by a non-contact respiratory sensor(Nightly during hospitalization (up to 7 days) and during one overnight recording at 6 weeks after hospital discharge)
- Correlation between nocturnal ventilatory variability and clinical worsening during hospitalization(From baseline (first night after hospitalization) through Day 7 of hospitalization or the day before discharge (maximum hospitalization duration: 7 days))
- Correlation between nocturnal ventilatory variability and physician-assessed readiness for hospital discharge(Daily from baseline (first night after hospitalization) until hospital discharge (up to 7 days))
- Association between nocturnal ventilatory variability and 28-day hospital readmission(Up to 28 days after hospital discharge)
- Correlation between nocturnal ventilatory variability and daytime ventilatory drive assessed by parasternal electromyography(Day 1, Day 3, Day 7 (or the night before discharge if discharge occurs earlier), and 6 weeks after hospital discharge.)