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Usefulness of a Telemedicine System for OSA Patients Follow-up With High Cardiovascular Risk (TELESAS)

2013年1月16日 更新者：Initiative Pour la Sante
The aim of this study is to determine the usefulness of a telemedicine system for the follow-up of OSA patients with a high cardiovascular risk. Our hypothesis is that the telemedicine system will enhance compliance and thus reduce self-measured blood pressure.

研究概览

地位

终止

条件

干预/治疗

详细说明

The obstructive sleep apnea syndrome (OSAS) corresponds to repeated epochs of complete or incomplete pharynx collapses occurring during sleep. The Continuous Positive Airway Pressure is the gold standard treatment for OSAS. It consists of air insufflation in upper airways with a pressure of about 5 to 15 cm of water with a facial or nasal mask. CPAP treatment reduces cardiovascular morbi-mortality.

OSAS is associated with cardiovascular mortality. A dose response effect exists between severity and arterial blood pressure. A recent meta-analysis has shown in unselected OSAS patients with or without hypertension, treated or non-treated for hypertension, CPAP reduces 24 h ambulatory blood pressure of approximately 2 mmHg. This decrease corresponds to a significant reduction in cardiovascular risk.

The aim of the present study is to include OSAS patients with a high cardiovascular risk and to measure the effect of CPAP on home measurements of arterial blood pressure. This controlled randomized trial will compare the effect CPAP on arterial blood pressure in a group with a telemedicine system versus a group with standard home care CPAP treatment.

An interim analysis will be carried out when 100 patients have been included in the study.

研究类型

介入性

注册 (实际的)

107

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

  • 法国
      • Boulogne Billancourt、法国、92100
        • Liberal Office
      • Brest、法国、29200
        • Clermont Tonerre military hospital
      • Chambery、法国、73000
        • Liberal Office
      • Grenoble、法国、38000
        • University Hospital
      • Grenoble、法国、38000
        • Liberal Office
      • Montigny les Metz、法国、57950
        • Liberal Office
      • Nancy、法国、54000
        • Liberal Office
      • Quimper、法国、29107
        • Cornouaille Hospital
      • St Andre les Vergers、法国、10120
        • Montier Polyclinic
      • St Avold、法国、57500
        • Hospitalor Hospital
      • St Jean de Maurienne、法国、73300
        • Liberal Office
      • St Martin les Boulogne、法国、62280
        • Liberal Office
      • StIsmier、法国、38330
        • Liberal Office
      • Strasbourg、法国、67000
        • Liberal Office

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

18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:

  • 18 to 85 years old men and women
  • stable patient
  • BMI<40kg/m²
  • OSA patients diagnosed with polysomnography or polygraphy
  • SCORE>5% and/or cardiovascular disease pas history :
  • transient ischemic attack, stroke, cerebral haemorrhagy
  • myocardial infraction, angor, coronary revascularization, arteriopathy, aortic aneurism

Exclusion Criteria:

  • central sleep apnea syndrome
  • SCORE<5%
  • cardiac failure
  • past history of hypercapnic chronic respiratory failure
  • past history of severe or intercurrent pathology which can not allow the patient follow-up
  • Incapacitated patients in accordance with article L 1121-6 of the public health code
  • patients taking part in another clinical trial

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：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Telemedecine
CPAP treatment with telemedicine system
设备：Telemedicine
CPAP treatment with telemedicine system
有源比较器：Standard Care
Standard care, including CPAP
设备：Standard care
Standard care, including CPAP

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
Home Arterial Blood Pressure
大体时间：Home arterial Blood Pressure is assessed at week 1
the primary outcome is assessed at weeks 1 and 16 for the both groups, moreover home arterial blood pressure is assessed each day, 2 times : morning and afternoon in the telemedicine group.
Home arterial Blood Pressure is assessed at week 1
Home Arterial Blood Pressure
大体时间：Home arterial Blood Pressure is assessed at week 16
the primary outcome is assessed at weeks 1 and 16 for the both groups, moreover home arterial blood pressure is assessed each day, 2 times : morning and afternoon in the telemedicine group.
Home arterial Blood Pressure is assessed at week 16

次要结果测量

结果测量
措施说明
大体时间
CPAP compliance
大体时间：week 16
the CPAP compliance is assessed in the two groups at week 16
week 16
Sleepiness
大体时间：weeks 1 and 16
Sleepiness is assessed with Epworth Sleepiness Scale at weeks 1 and 16 for the two groups
weeks 1 and 16
Physical Activity
大体时间：week 1
Daily Physical Activity is assessed with an accelerometer (Sensewear Armband, Bodymedia) at weeks 1 and 16 in the two groups. Daily expenditure, steps number, daily METs are assessed.
week 1
Quality of Life
大体时间：week 16
Quality of life is assessed with SF-12 questionnaire at weeks 1 and 16 in the two groups.
week 16
Cardiovascular risk SCORE
大体时间：Week 1
The cardiovascular risk SCORE is assessed at weeks 1 and 16 in the two groups.
Week 1
Sleepiness
大体时间：week 16
Sleepiness is assessed with Epworth Sleepiness Scale at weeks 1 and 16 for the two groups
week 16
Physical Activity
大体时间：week 16
Daily Physical Activity is assessed with an accelerometer (Sensewear Armband, Bodymedia) at weeks 1 and 16 in the two groups. Daily expenditure, steps number, daily METs are assessed.
week 16
Quality of Life
大体时间：week 1
Quality of life is assessed with SF-12 questionnaire at weeks 1 and 16 in the two groups.
week 1
Cardiovascular risk SCORE
大体时间：Week 16
The cardiovascular risk SCORE is assessed at weeks 1 and 16 in the two groups.
Week 16

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

Initiative Pour la Sante

调查人员

  • 首席研究员：Jean Louis PEPIN, Prof, PhD、University Hospital, Grenoble

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

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

2009年7月1日

初级完成 (实际的)

2012年1月1日

研究完成 (实际的)

2012年1月1日

研究注册日期

首次提交

2010年10月20日

首先提交符合 QC 标准的

2010年10月21日

首次发布 (估计)

2010年10月22日

研究记录更新

最后更新发布 (估计)

2013年1月17日

上次提交的符合 QC 标准的更新

2013年1月16日

最后验证

2013年1月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • InitiativePS-TELESAS

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.

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