Non-inferiority Randomized Control Trial About Efficacy and Cost-effectiveness of Home Respiratory Polygraphy Management in Sleep Apneas/Hypopneas Syndrome
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 440
- 试验地点
- 2
- 主要终点
- Determine the efficacy of diagnosis and therapeutic decision-making evaluated using Epworth sleepiness scale as primary variable in patients managed by home RP and by PSG after six months of follow-up.
研究概览
简要总结
Primary objectives:
The efficacy of the therapeutic decision taken by respiratory polygraphy (RP) against polysomnography (PSG) using the Epworth scale;
Secondary Objective:
- the cost-effectiveness of diagnosis and therapeutic decision valued using the Epworth Scale and EuroQol 5D.
- effectiveness of the therapeutic decision by means of: 1) quality of life tests, 2) adherence and compliance to treatment, 3) blood pressure MAP, 4) biochemistry determinations. Design: prospective, randomized, controlled, open, parallel of non-inferiority. 440 patients will be randomized to diagnose and follow treatment based on the RP or the PSG. The follow-up will last 6 months with 4 assessments. Statistical analysis: We will compare the change in the Epworth scale between both arms of treatment through analysis of covariance. The premise of non-inferiority is -2 at the lower limit of 95% IC. Secondary variables will be analyzed using differences in independent means (or non-parametric equivalent) or Chi2 for dichotomous variables. Cost-effectiveness: costs generated by one and another method will be evaluated against the effectiveness of the primary variable using Bayesian techniques
详细描述
Design: Prospective, randomized, controlled, open, parallel noninferiority. 440 patients will be randomized to diagnose and follow treatment based on the PR or PSG generating four groups: two treated and two untreated with CPAP. The latter did not undergo self-certification home. The monitoring will be 6 months and 4 assessments. Statistical analysis: compare the change of the scale Epworth before and after the intervention between both treatment arms using analysis of covariance. The premise is non-inferiority of -1.6 at the lower limit of 95%. Secondary variables were analyzed by independent means differences (or nonparametric equivalent) or Chi2 for dichotomous variables. Cost-effectiveness: the costs generated by the two methods will be measured against the effectiveness of the primary endpoint using Bayesian techniques
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 sleep apneas observed by partner
- •Symptoms that may be secondary to the apneas/hypopneas - concretely, an ESS ≥10
- •Age between 18 and 70
- •Absence of clinical suspicion of any other sleep pathology which could cause daytime sleepiness
排除标准
- •Psycho-physical inability to complete questionnaires
- •documented structural or coronary cardiopathy not controlled by medical treatment
- •Cheyennes-Stokes Syndrome
- •Patient has undergone an uvulopalatopharyngoplasty
- •Unable to provide informed consent
结局指标
主要结局
Determine the efficacy of diagnosis and therapeutic decision-making evaluated using Epworth sleepiness scale as primary variable in patients managed by home RP and by PSG after six months of follow-up.
时间窗: Six months
次要结局
- the cost-effectiveness of diagnosis and therapeutic decision valued using the Epworth Scale and EuroQol 5D.(Six months)
研究者
Juan F. Masa
MD
Sociedad Española de Neumología y Cirugía Torácica