Management of Patients With Suspected Sleep Apnea Syndrome From Primary Care: Territorial Assistance Network.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 280
- 试验地点
- 2
- 主要终点
- Change from baseline in daytime sleepiness (ESS score) at 6 months
研究概览
简要总结
Obstructive sleep apnea syndrome (OSA) is characterized by the manifestation of excessive sleepiness secondary to repeated obstruction of the upper airway during sleep and cognitive-behavioral, respiratory, cardiac, metabolic or inflammatory disorders. Epidemiological studies in our country have shown that OSA is a highly prevalent disease in the general population, affecting 2-4% of the adult population. The most important clinical manifestations of OSAS is a deterioration in the quality of life and an increase in cardiovascular disease. OSA is also associated with traffic accidents. Therefore, and considering the medical complications of OSA, as well as the sociolaboral impact and its negative impact on quality of life and survival; is stated that this disease is a public health problem that requires the physician to identify patients eligible to treatment. Moreover, it has been shown that undiagnosed patients, duplicate the consumption of health resources, comparing when the diagnosis and treatment has been established. Finally, we have a highly effective treatment using positive pressure in the upper airway (CPAP) that has been shown to be effective and cost-effective. The current situation in which all patients diagnosed with OSA and receiving different treatments are monitored and controlled by the Sleep Units (SU) is an oversized medicine specialist at the expense of primary care (PC). Our working hypothesis is: "By the coordination of actions at various levels including interactive training equipment AP, use the bilateral (SU-AP) of electronic medical records and the use of new technologies can be achieved in AP satisfactory management of the diagnostic and therapeutic process of patients with suspected OSA. Patients assisted in both areas have a level of clinical response, satisfaction, compliance and avoidance of complications, similar to that obtained with monitoring by SU. In addition, management by AP will be more cost-effective than in the SU."
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
- •Suspected OSA patients (chronic snoring, apneas, excessive daytime sleepiness) or resistant hypertension
- •Written informed consent signed
排除标准
- •Patients with impaired lung function (sd. overlap, obesity hypoventilation, 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
Change from baseline in daytime sleepiness (ESS score) at 6 months
时间窗: baseline and 6 months
Epworth Sleepiness Scale (ESS)
Cost-effectiveness at 6 months
时间窗: 6 months
QUALYS
次要结局
- Change from baseline in body mass index(Baseline and 6 months)
- Adverse events at 6 months(6 months)
- Change from baseline in blood pressure(Baseline and 6 months)
- Lost of follow up / Abandons at 6 months(6 months)
- Change from baseline in quality of life(baseline and 6 months)
- CPAP compliance at 6 months(6 months)
- Satisfaction at 6 months(6 months)
研究者
Ferran Barbe
MD
Sociedad Española de Neumología y Cirugía Torácica
