MyOSA : Management and Treatment of Patients With Obstructive Sleep Apnea Syndrome(OSAS) Through a Telemedicine System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- CPAP compliance
研究概览
简要总结
The purpose of this study is to improve CPAP treatment compliance of Obstructive Sleep Apnea Syndrome using an integrated telemedicine platform (MyOSA system)
详细描述
Obstructive Sleep Apnea (OSA) is defined by the presence of repetitive episodes of upper airways collapse during sleep, leading to nocturnal hypoxemia, sleep fragmentation and daytime sleepiness. When untreated, OSA is a risk factor for arterial hypertension , cardiovascular and cerebrovascular diseases, road accidents and a worse quality of life. The application of a continuous positive airways pressure (CPAP) represents the first line therapy in patients with moderate to severe OSA. CPAP treatment improves daytime sleepiness and oxygen saturation, reduces cardiovascular risk, ameliorates neurobehavioral performance, improves quality of life and reduces road accidents. Despite its demonstrated efficacy, CPAP effectiveness is significantly limited by poor adherence. A closer follow up could improve CPAP adherence but it would take up more work and additional costs for sleep units.
So, on that account, the investigators propose a study to evaluate the effect of adding a telemedicine approach to traditional follow up on CPAP treatment compliance, patients' satisfaction and follow-up costs.
Telemedicine will be provided by an integrated platform composed by a web site (https://www.myosa.net/menu/login.aspx) and a smartphone application.
Methods:
Design: Prospective randomised clinical study. Follow up: 6 months. Participants: 60 patients diagnosed as OSA at St. Maria's Hospital (Sleep Unit) and requiring CPAP treatment.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and Women over 18 years old
- •Diagnosed as OSA and requiring CPAP treatment
- •Good knowledge of the use of a smartphone
- •Written informed consent form signed
排除标准
- •Patients with impaired lung function (overlap syndrome, obesity hypoventilation syndrome, and restrictive disorders)
- •Severe heart failure
- •Severe chronic pathology associated
- •Psychiatric disorder
- •Periodic leg movements
- •Pregnancy
- •Other dyssomnias or parasomnias
- •Patients already treated with CPAP
研究组 & 干预措施
Standard care
Patients diagnosed as OSA, treated with CPAP and followed up in sleep unit as per usual care.
Patients will be fitted with a mask and given a CPAP and instructed on how to use the device. Each CPAP machine will be provided with a modem sending daily compliance and adherence information to MyOSA web site but no intervention based on these data is planned in this group. All patients will be visited at 1,3 and 6 months at sleep unit. Patients will be checked about progress and adherence to therapy and any problems with their machine. Information will be downloaded from their machines (CPAP adherence, applied CPAP pressure, mask leak, and residual respiratory events...).
干预措施: CPAP + Standard care (Device)
Telemedicine
Patients diagnosed as OSA and treated with CPAP, followed up in sleep unit, adding a telemedicine integrated system.
Patients will be fitted with a mask , given a CPAP, and instructed on how to use the device. Using patients' baseline and initial follow-up data a software will provide a prediction of CPAP compliance at 6 months, and propose personalized interventions to increase compliance (smartphone app). All patients will be visited at 3 and 6 months at sleep unit. Patients will be checked about progress and adherence to therapy and any problems with their machine.
干预措施: CPAP + Telemedicine (Device)
结局指标
主要结局
CPAP compliance
时间窗: 6 months
Number of hours of use per day of CPAP according to the internal clock of the CPAP device
次要结局
- Change in weight (in kg) at 6 months(at baseline and 6 months)
- Change in body mass index (in kg/m^2) at 6 months(at baseline and 6 months)
- Patients' perceived ease of use of the telemedicine system(6 months)
- Patients' perceived useful of the telemedicine system(6 months)
- Change from baseline in quality of life at 6 months(at baseline and 6 months)
- CPAP adherence(6 months)
- Cost effectiveness at 6 months(6 months)
- Abandons at 6 months(6 months)
- Change from baseline in daytime sleepiness at 6 months(at baseline and 6 months)
- Change in blood pressure at 6 months(at baseline and 6 months)
- Change from baseline in Visual analogue scale for quality of life at 6 months(at baseline and 6 months)
- Changes in treatment side effects(6 months)
- Patients' follow-up satisfaction(6 months)
研究者
Ferran Barbe
Head of Respiratory department at Hospital Universitari Arnau de Vilanova
Sociedad Española de Neumología y Cirugía Torácica