跳至主要内容
临床试验/NCT02234765
NCT02234765已完成不适用

Management of Patients With Suspected Sleep Apnea Syndrome From Primary Care: Territorial Assistance Network.

Sociedad Española de Neumología y Cirugía Torácica2 个研究点 分布在 1 个国家目标入组 280 人开始时间: 2014年5月1日最近更新:
适应症

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

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

发起方
Sociedad Española de Neumología y Cirugía Torácica
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ferran Barbe

MD

Sociedad Española de Neumología y Cirugía Torácica

研究点 (2)

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