Efficacy and Cost-Effectiveness of a Super Simplified System for the Management of Patients With Sleep Apneas in Primary Healthcare.
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
- 1
- 主要终点
- Efficacy of the extra- and intra-hospital programs using DNP or PSG, taking as primary variable the Epworth scale.
研究概览
简要总结
Primary objectives: To determine the efficacy and cost-effectiveness of a management program for patients with obstructive sleep apnea syndrome (OSAS) carried out in primary or specialist healthcare. In the primary arm, the diagnosis and therapeutic decision will be made by means of a domiciliary nasal pressure (DNP) channel and oximetry while the specialist healthcare arm will use polysomnography (PSG) in a hospital. Patients with an intermediate-high suspicion of OSAS will be included, taking as primary variables the Epworth scale, for efficacy, and the Epworth scale and EuroQol 5D, for cost-effectiveness.
Secondary objectives: efficacy of the two SAHS management programs according to the following secondary variables: a) quality-of-life tests: FOSQ questionnaire, SF36 and analogical wellbeing scale, b) adherence to and compliance with the treatment.
详细描述
Design: prospective, randomized, controlled, open, parallel, non-inferiority. A total of 280 patients will be randomized for management on the basis of DNP (primary) or PSG (specialist), thereby giving rise to 4 groups: two treated and two not treated with CPAP. The former will undergo a home auto-titration. The follow-up will last 6 months and include 4 evaluations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Snoring or apneas objectively observed during sleep by a partner;
- •Symptoms that are potentially secondary to apneas/hypopneas with an intermediate-high probability of being treated with CPAP. In operative terms, Epworth scale ≥12 or previous cardiovascular disease;
- •Age between 18 and 70 years;
- •Absence of any clinical suspicion of any other sleep pathology susceptible to coinciding with daytime sleepiness.
排除标准
- •Psycho-physical incapacity to complete questionnaires;
- •Documented structural or coronary heart disease uncontrolled by any medical treatment;
- •Cheyne-Stokes syndrome;
- •Patients subjected to uvulopalatopharyngoplasty;
- •Significant nasal obstruction impeding the use of CPAP;
- •Lack of informed consent.
研究组 & 干预措施
Primary.
Diagnosis, autoCPAP, follow up.
干预措施: Diagnosis, autoCPAP, follow up. (Device)
Hospital
Diagnosis, autoCPAP, follow up
干预措施: Diagnosis, autoCPAP, follow up. (Device)
结局指标
主要结局
Efficacy of the extra- and intra-hospital programs using DNP or PSG, taking as primary variable the Epworth scale.
时间窗: Before and after 6 months of follow-up
次要结局
- Cost-effectiveness of the exta- and intra-hospital management programs using DNP or PSG, evaluated by means of the Epworth scale and EuroQol 5D.(Before and after 6 months of follow-up)
研究者
Juan F. Masa
MD
Sociedad Española de Neumología y Cirugía Torácica