Wearable Noninvasive Positive Pressure Ventilation Device in COPD (VITABREATH)
2018年10月1日 更新者：Icadom
Evaluation of the Impact of a Wearable Noninvasive Positive Pressure Ventilation Device on Physical Activity and Quality of Life in Patients With COPD
The objective is to assess the impact of a wearable Noninvasive Positive Pressure Ventilation, on physical activity and quality of life in patients with severe COPD, complaining of dyspnea.
研究概览
详细说明
In order to avoid the occurrence of uncomfortable dyspnea, patients with Chronic Obstructive Pulmonary Disease (COPD) are locked in a vicious circle of inactivity and social isolation which profoundly affects their quality of life and prognosis. A new wearable non invasive positive pressure ventilation device has been recently proposed; it can be used by intermittence during or after physical activities for reducing dyspnea or for shortening dyspnea- recovery time. The investigators hypothesize that this system, in reducing the inconvenience caused by dyspnea, would stimulate a more active lifestyle and improve quality of life. Their objective is to assess the impact of this device on physical activity and quality of life in patients with severe COPD, complaining of dyspnea.
In this open study with no control group, participants will use the device at their convenience, according to their needs in daily life and for 4 weeks.
研究类型
介入性
注册 (实际的)
40
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Alès、法国、30100
- Dr Michèle Bognie Pneumology Office
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Castelnau-le-Lez、法国、34000
- Clinique du Parc
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Grenoble、法国、38043
- CHU Grenoble-Alpes
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Lille、法国、59042
- Hôpital Privé La Louvière
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Lunel、法国、34400
- Dr Christian PAILLARGUELO Pneumology Office
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Nîmes、法国、30900
- CHU Caremeau
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Toulouse、法国、31300
- Clinique Pasteur
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
35年 至 85年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Patients with stable severe COPD (with FEV1 ≤50% predicted)
- Patients with mMRC score > ou = 2.
Exclusion Criteria:
- Exacerbate within a month prior.
- Using other non invasive ventilation device > 15h per day.
- Have musculoskeletal or neuromuscular problem affecting balance and walking.
- Have cognitive problem affecting comprehension of the different évaluations or questionnaires.
- Have recently participated in physical training or rehabilitation program (≤ 3 months).
- Medical contra-indication to NIV.
- Evolutionary pathologies (excluding COPD) may be life-threatening in the short term (1 year) (cancer, neuromuscular disease rapidly changing).
- Simultaneously enrolled in an other clinical trial.
- Not affiliated to social security.
- Person deprived of liberty, major protected by law.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：设备可行性
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Noninvasive ventilation
Participants will use the device at home by intermittence during or after physical activities for reducing dyspnea or for shortening dyspnea-recovery time over a 4-week period.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change of daily physical activity measured by actimetry
大体时间：Continuously over a 8-week period (2 weeks before the use of the device, over the 4-week period usinf the device and 2 weeks after the use of the device
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Change of number of steps by day and daily energy expenditure over the 8 week period
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Continuously over a 8-week period (2 weeks before the use of the device, over the 4-week period usinf the device and 2 weeks after the use of the device
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change of Baseline Dyspnea Index (BDI) score
大体时间：baseline and post use of the Vitabreath device at 4th weeks
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The BDI represents importance and impact of dyspnea in daily life of COPD patients.
The BDI is one of dyspnea parameters (questionnaire).
Three dimension questions include; 1.effect of daily function on dyspnea, 2. effect of magnitude of task on dyspnea and 3. effect of magnitude off effort on dyspnea.
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baseline and post use of the Vitabreath device at 4th weeks
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Change of Modified Medical Research Council Questionnaire (mMRC) score
大体时间：baseline and post use of the Vitabreath device at 4th weeks
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The mMRC is one of dyspnea parameters
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baseline and post use of the Vitabreath device at 4th weeks
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Change of Transition Dyspnea Index (TDI)
大体时间：baseline and post use of the Vitabreath device at 4th weeks
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The TDI assesses change of dyspnea perception from the BDI in each dimensions.
Patient will rate score from -6 to +6 (positive score reflect improve of dyspnea and negative score reflect worse dyspnea).
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baseline and post use of the Vitabreath device at 4th weeks
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Subjective appréciation of the device
大体时间：post use of the Vitabreath device at 4th weeks
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Patients will rate their appreciation of the device using 3 scale relatives to ease of use, helps recovery shortness of breath, helps to be more active in daily life
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post use of the Vitabreath device at 4th weeks
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Change of Visual Simplified Respiratory Questionnaire (VSRQ) score
大体时间：baseline and post use of the Vitabreath device at 4th weeks
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The VRSQ represents health related quality of life of COPD patients
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baseline and post use of the Vitabreath device at 4th weeks
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Change of Chronic Obstructive Pulmonary Disease Assessment Test (CAT)score
大体时间：Continuously over a 8-week period (2 weeks before the use of the device, over the 4-week period usinf the device and 2 weeks after the use of the device
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The CAT represents health related quality of life of COPD patients
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Continuously over a 8-week period (2 weeks before the use of the device, over the 4-week period usinf the device and 2 weeks after the use of the device
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Compliance to the device
大体时间：Every week over the 4-week period
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During a weekly phone call, patients will indicate the daily duration and conditions of use of the device
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Every week over the 4-week period
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Number of acute exacerbation
大体时间：Up to 12 months before the date of inclusion
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Exacerbation is defined as changing the respiratory status of the patient relative to the patient's usual state, which requires acute hospitalisation.
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Up to 12 months before the date of inclusion
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Weight
大体时间：baseline and post use of the Vitabreath device at 4th weeks
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Patient will indicate their weight
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baseline and post use of the Vitabreath device at 4th weeks
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
调查人员
- 首席研究员：Jean-Louis PEPIN, Pr、Laboratoire du sommeil - Centre hospitalier Universitaire Michallon - 38043 GRENOBLE
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2017年1月12日
初级完成 (实际的)
2018年1月10日
研究完成 (实际的)
2018年1月10日
研究注册日期
首次提交
2016年8月16日
首先提交符合 QC 标准的
2017年4月21日
首次发布 (实际的)
2017年4月26日
研究记录更新
最后更新发布 (实际的)
2018年10月3日
上次提交的符合 QC 标准的更新
2018年10月1日
最后验证
2018年10月1日
更多信息
与本研究相关的术语
其他研究编号
- 2016-A01297-44
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
未定
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
无创通气的临床试验
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Rutgers, The State University of New Jersey完全的
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Taichung Veterans General Hospital完全的心脏毒性 | 非小细胞肺癌（MeSH术语：Carcinoma, Non-Small-Cell Lung） | 药物相关副作用和不良反应（MeSH术语） | 表皮生长因子受体酪氨酸激酶抑制剂台湾
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Fondazione del Piemonte per l'Oncologia招聘中乳腺癌 | 卵巢癌 | 结直肠癌 | 黑色素瘤（皮肤癌） | 非小细胞肺癌（MeSH术语：Carcinoma, Non-Small-Cell Lung）意大利
Non-Invasive Ventilation的临床试验
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Sheffield Hallam UniversitySheffield Teaching Hospitals NHS Foundation Trust完全的
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Charite University, Berlin, Germany招聘中