Telemonitoring for the Recuperation of Patients With CPAP
研究概览
详细说明
Given the prevalence of Obstructive Sleep Apnea (OSA), the symptoms it produces, which is a risk factor for various entities and that, in addition, its treatment clearly improves others; its control must be optimized in an effective and cost-effective manner. The use of information and communication technologies (ICT) in this context can be very beneficial.
The design of the study is prospective, randomized, controlled, open and parallel.
A ICT-based out of hospital management of OSA is implemented to be compared with the classical in-hospital management.
The main objectives were to evaluate the effectiveness of of two OSA management programs: the in-hospital classic management versus a telemedicine program based on the use of ICTs in the recovery of patients with OSA who who do not meet the minimum treatment (4 hours) or in those who do not comply with the optimal use (5.5 hours).
This is a 4-weeks management randomized, with parallel groups study. Participants will be patients from the Sleep Unit of Hospital Clinic Barcelona with OSA diagnosis and CPAP treatment indication, who after a follow-up between 3-months and up to 5 years have a CPAP compliance below 5,5 hours/night.
Two management programs will be compared:
- In-hospital classic management: Patients are followed regularly in the hospital with a face-to-face visit by the Sleep unit nurse.
- Telemedicine management: telemedicine support with mobile app, voicemail and CPAP remote monitoring.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Josep M Montserrat, Prof
- 电话号码：932275746
- 邮箱：jmmontserrat@ub.edu
学习地点
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Cataluña
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Barcelona、Cataluña、西班牙、08036
- 招聘中
- Josep M Montserrat Canal
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接触：
- Monique C Suarez Giron, MD PhD
- 电话号码：5746 932275746
- 邮箱：mcsuarez@clinic.cat
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接触：
- Onintza Garmendia, MsC
- 电话号码：5746 932275746
- 邮箱：garmendia@clinic.cat
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Age ≥ 18 years,
- CPAP treatment initiated ≥1 month and <12 months
- CPAP compliance below 5.5 hours per night,
- Regular use of Smartphone and mobile apps.
Exclusion Criteria:
- Clinical suspicion or other confirmed sleep pathology,
- Severe nasal obstruction that prevents the use of CPAP,
- Physical-psychological inability to follow questionnaires and the program,
- Patients undergoing uvulopalatopharyngoplasty,
- Cheyne-Stokes syndrome,
- Pregnancy,
- Rejection in the initial test with CPAP during the training and education session and
- Failure to obtain informed consent.
学习计划
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 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 |
|---|---|
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有源比较器：Hospital management
Patient's receive no intervention, the follow up is the usual for a patient following CPAP therapy.
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Face-to-face follow up
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实验性的：Telemedicine management
CPAP remote monitoring of patients, including a mobile application and a voicemail.
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Remote CPAP monitoring, mobile app and voice mail
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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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CPAP use
大体时间：4-weeks
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Compliance to CPAP treatment (Number of hours that the patient uses CPAP) will be taken as the main variable.
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4-weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Quality of life assessment
大体时间：4-weeks
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Functional Outcomes Sleep Questionnaire (FOSQ) and EuroQol-5D (EQ-5D)
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4-weeks
|
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Sleepiness assessment
大体时间：4 weeks
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Epworth sleepiness scale (ESS)
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4 weeks
|
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Satisfaction assessment
大体时间：4 weeks
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Satisfaction questionnaire
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4 weeks
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合作者和调查者
调查人员
- 研究主任：Josep M Montserrat, Prof、Hospital Clinic/Universitat de Barcelona
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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.
In Hospital的临床试验
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Maastricht University Medical CenterRadboud University Medical Center完全的
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BlueWillow BiologicsNational Institute of Allergy and Infectious Diseases (NIAID); University of Maryland, Baltimore主动，不招人