Cloud Based Follow up of CPAP Treatment in Sleep Apnea Patients - a Multi Center Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 403
- 试验地点
- 2
- 主要终点
- CPAP treatment compliance at 3 months
研究概览
简要总结
Obstructive sleep apnea (OSA) is treated with a continuous positive airway pressure, so called CPAP. A new technology that enables telemetric monitoring of CPAP therapy. This study randomizes 560 patients to A) conventional follow up procedures or B to a telemedicine based follow up procedure. Main endpoint parameter is CPAP treatment compliance at 3 months after start of treatment.
详细描述
Background:
Obstructive sleep apnea (OSA) is treated with a continuous positive airway pressure, so called CPAP, during sleep. CPAP startup and follow-up is performed at four sleep clinics in the West Swedish Region (SU / S, SÄS, SkaS, NÄL). Patient volumes are high, waiting times are long and long-term follow-up is inconsistent. A new technology that enables telemetric monitoring of CPAP therapy based on transfer of therapy data to a data cloud has been introduced. Healthcare personnel can identify patients with therapy problems.
Data from minor studies suggest several benefits of this telemedicine solution (increased therapeutic capacity, lower patient and community costs and a time benefit for the sleep medicine unit). Today, the sleep Clinical in the region use different procedures for monitoring CPAP treatment.
Scientific question:
Is telemedicine monitoring of CPAP treatment an adequate solution for follow up in all patients ? Is the additional cost of a telemedicine solution balanced by a better outcome after therapy?
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Verified sleep apnea diagnosis according to ICSD II criteria
- •Indication for CPAP treatment according to Swedish national guidelines
- •Capacity to read and understand the Swedish language
- •Willingness to test CPAP treatment
排除标准
- •Instable concomitant disease requiring frequent hospitalization
- •Alcohol and drug abuse
- •Non-availability during the follow up during 3 months (e.g. frequent or long-term travelling)
- •Hypoventilation syndrome with PCO2>7kpa
结局指标
主要结局
CPAP treatment compliance at 3 months
时间窗: 3 months
Mean nightly use of CPAP treatment (h/night) according to the built in time counter of the CPAP device, between group difference
次要结局
- Reduction of daytime sleepiness(3 months)
- Reduction of the degree of sleep apnea(3 months)
- Non Acceptance Rate of CPAP therapy(3 months)
- Health care utilization during follow up(3 months)
- Patient satisfaction regarding the follow up procedure(3 months)
研究者
Ludger Grote
MD, Senior Consultant, Professor
Vastra Gotaland Region