Applicability, Efficacy and Cost Effectiveness of Sleep Apnoea Hypopnea Syndrome (SAHS) Management by an Information and Communication Based Technology (ICT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 151
- 试验地点
- 2
- 主要终点
- Evaluation of the two SAHS management programs
研究概览
简要总结
This project develops a new form of management of subjects with suspected SAHS and different sleep disorders by applying Information and communications technologies (ICT).
详细描述
Sleep apnea hypopnea syndrome (SAHS) is a prevalent disease with significant morbidity resulting in long waiting lists and high health care costs. Therefore, alternative cost-effective approaches are urgently needed. A possible procedure is telemedicine based on ICT.
The design of the study is prospective, randomized, controlled, open and parallel.
A ICT-based out of hospital management of SAHS is implemented to be compared with the classical in-hospital management.
The main objectives were the evaluation of both groups and the analysis of efficacy and cost effectiveness of two SAHS management programs.
This is a 3 month randomized, with parallel groups study. Participants will be patients with suspicion of SAHS derived to the Investigators' Sleep Unit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Clinical suspicion of SAHS
- •Use of Smartphone and internet
排除标准
- •Severe hypersomnia
- •Central apneas or other sleep disorder
- •Previous CPAP treatment
- •Unstable diseases
- •Profession of risk
- •Not able to complete questionnaires
- •No written informed consent
研究组 & 干预措施
Hospital group
Patients referred to the sleep unit and randomized to Hospital group. Participants will be diagnosed in the hospital either by Polysomnography , Respiratory Polygraphy or one night Home Respiratory Polygraphy. In case of requiring CPAP treatment, the titration and adjustment of patient's will be accomplished at the hospital. This patient's will be monitored during 3 months of the study at the hospital.
ICT group
Patients referred to the sleep unit and randomized to intervention group. Participants will be diagnosed at home by 3 night Home Respiratory Polygraphy. In case of requiring CPAP treatment, the adjustment will be performed at the CPAP supplier center, titration will be performed at home and patient's compliance and treatment will be controlled via remote. During the 3 months of the study patient's will be controlled via phono/video conferences and with a platform designed for the study.
干预措施: Remote control of patients (Other)
结局指标
主要结局
Evaluation of the two SAHS management programs
时间窗: 3 months
Quebec sleep questionnaire
次要结局
- Cost-effectiveness of the two SAHS management programs(3 months)
研究者
Jose M. Montserrat
Principal investigator
Hospital Clinic of Barcelona