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临床试验/NCT02884830
NCT02884830撤回不适用

Does Nocturnal Continuous Positive Airway Pressure Use Improves Sleep Quality in Chronic Obstructive Pulmonary Disease Patients?

Centre Hospitalier Universitaire Saint Pierre0 个研究点开始时间: 2019年1月7日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
主要终点
sleep quality

研究概览

简要总结

Static hyperinflation is frequent in Chronic obstructive pulmonary disease (COPD) , resulting in increased end expiratory lung volume and positive end expiratory pressure (PEEPi) at the end of a normal expiration.

Static hyperinflation worsens the work of breathing is increases patient's dyspnea.

The application of a continuous positive airway pressure (CPAP) has been shown to improve static hyperinflation and to decrease the work of breathing.

Sleep is deteriorated in COPD patients, and causal factors includes static hyperinflation. The purpose of our study is to assess the effect of nocturnal CPAP on sleep quality and functional respiratory parameters.

详细描述

Chronic obstructive pulmonary disease (COPD) is characterized by an airflow obstruction, inducing a flow limitation. As a consequence, we observe in these patients an increased end expiratory lung volume and a positive end expiratory pressure (PEEPi) at the end of a normal expiration.

Patients are breathing at higher pulmonary volumes: this is the concept of static hyperinflation.

This worsens the breathing pattern because in this situation, the work of breathing is increased such that dyspnea increases.

The application of a continuous positive airway pressure (CPAP) has been shown to improve static hyperinflation and to decrease the work of breathing.

Sleep is deteriorated in COPD patients, and causal factors includes static hyperinflation, cough, depression. Moreover, normal physiological changes occuring during sleep in COPD patients are leading to deterioration of gaseous exchanges. The purpose of our study is to assess the effect of nocturnal CPAP on sleep quality and functional respiratory parameters.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • stable chronic obstructive pulmonary disease patients exhibiting a FEV1<80 %,

排除标准

  • Known sleep apnea syndrome or other sleep disease interfering with sleep quality
  • Body mass index > 30 kg/m2
  • heart failure
  • hypnotics intake

结局指标

主要结局

sleep quality

时间窗: day 1

sleep efficiency, total sleep time, sleep architecture measured by polysomnography

次要结局

  • static hyperinflation(day 1)

研究者

发起方
Centre Hospitalier Universitaire Saint Pierre
申办方类型
Other
责任方
Sponsor

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