Efficacy of Telemonitoring on CPAP Treatment Compliance in Obstructive Sleep Apnea (OSA) Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- CPAP adherence at 3 months
研究概览
简要总结
The purpose of this study is to compare the effectiveness of telemonitoring versus standard follow-up on CPAP treatment compliance in Obstructive Sleep Apnea Syndrome (OSAS).
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 demonstrate that automatic home treatment monitoring of patients with OSA is a cost-effectiveness alternative approach to patient's management. Moreover, the investigators believe that telemonitoring could improve CPAP compliance and patient's satisfaction and reduce follow-up costs.
Methods:
Prospective and randomized study during three months. Patients diagnosed as OSA in St. Maria's Hospital (Sleep Unit) and requiring CPAP treatment, will be randomized into two groups differing in CPAP compliance monitoring and management .
Group 1 Standard care Patients will be fitted with a mask and given a CPAP and instructed on how to use the device. Patients will follow the standard treatment management. All patients will be visited at 1 month 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...).
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
- •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
结局指标
主要结局
CPAP adherence at 3 months
时间窗: 3 months
Number of hours of use per day of CPAP according to the internal clock of the CPAP device
次要结局
- Patients' satisfaction at 3 months(3 months)
- Change in body mass index at 3 months(3 months)
- Change from baseline in quality of life at 3 months(3 months)
- Fast detection of the non-adherent patient with telemonitoring(3 months)
- Change from baseline in snoring at 3 months(3 months)
- Changes in sleep fragmentation at 3 months(3 months)
- Changes in nocturnal gasping at 3 months(3 months)
- Abandons at 3 months(3 months)
- Adverse events at 3 months(3 months)
- Change from baseline in witnessed apneas at 3 months(3 months)
- Presence of symptoms of restlees leg syndrome at 3 months(3 months)
- Cost effectiveness at 3 months(3 months)
- Change in blood pressure at 3 months(3 months)
- Change from baseline in nocturia at 3 months(3 months)
- Change from baseline in daytime sleepiness at 3 months(3 months)
研究者
Ferran Barbe
MD
Sociedad Española de Neumología y Cirugía Torácica