NCT01848509已完成不适用
A Telemedicine System for the Follow-up of Patients With SAS
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 201
- 试验地点
- 1
- 主要终点
- CPAP adherence measured by the number of hours of nightly use
研究概览
简要总结
Objective: Set up an interoperable telemedicine system for the follow-up of patients with sleep apnea syndrome.
详细描述
The medico-economics protocol will use the MAST (Methodology for Assessment of Telemedicine) criteria. 200 patients will be randomized into 2 arms (telemedicine with GPRS transmission of CPAP data from patients' home and classical follow-up) during the 3 first months of the follow-up. The main end-point is CPAP compliance with the aim of detecting a mean increase of at least 1hr in the use of CPAP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •AHI > 30/hr
- •hypersomnolence
- •agreement for the use of CPAP
- •internet and GSM connection
排除标准
- •central apnea >20%,
- •pneumothorax,
- •severe nasal obstruction,
- •previous pharyngeal surgery,
- •severe COPD,
- •heart failure,
- •previous use of CPAP,
- •no social security coverage,
- •unavailability,
- •no GSM and internet network
研究组 & 干预措施
Without telemonitoring
No Intervention
Without teletransmission of alerts
With telemonitoring
Experimental
With teletransmission of alerts
干预措施: With teletransmission (Device)
结局指标
主要结局
CPAP adherence measured by the number of hours of nightly use
时间窗: 3 Months
次要结局
- Organizational changes of home care providers and medical structures(9 months after the first patient inclusion)
- Perception of healthcare professionals (autoquestionnaire RENEWING HEALTH)(3 months)
- economics: cost estimation: investment and running costs(3 months)
- Quality of life(3 months)
- Patients satisfaction(3 months)
研究者
研究点 (1)
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