Home Nasal Pressure for Sleep Apnea Management in Primary Case (Primary)
Efficacy and Cost-Effectiveness of a Super Simplified System for the Management of Patients With Sleep Apneas in Primary Healthcare.
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.
研究概览
详细说明
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Cáceres、西班牙、10005
- Juan Fernando Masa Jiménez
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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;
- Pregnancy;
- Lack of informed consent.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Primary.
Diagnosis, autoCPAP, follow up.
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comparison between the efficacy of two protocol
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有源比较器：Hospital
Diagnosis, autoCPAP, follow up
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comparison between the efficacy of two protocol
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Efficacy of the extra- and intra-hospital programs using DNP or PSG, taking as primary variable the Epworth scale.
大体时间：Before and after 6 months of follow-up
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Before and after 6 months of follow-up
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Cost-effectiveness of the exta- and intra-hospital management programs using DNP or PSG, evaluated by means of the Epworth scale and EuroQol 5D.
大体时间：Before and after 6 months of follow-up
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Before and after 6 months of follow-up
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合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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