Cost-effectiveness Analysis of Home Polysomnography Made by Primary Care - (SONOPC Study) (SONOPC)
Cost-effectiveness Analysis of Home Polysomnography Made by Primary Care Compared to Standard Protocol in Health Public System in Brazil
The goal of this randomized clinical trial is to assess the cost-effectiveness of a home polyssomnography made by primary care compared to standard protocol for diagnosing obstructive sleep apnea in both genders. Researchers will compare if a polyssomnography made by primary care is more cost-effective than standard protocol to see if this strategy decrease the wait time to get this exam in public health system in Brazil .
Participants will undergo diagnostic screening using the STOP-BANG and Epworth questionnaires; following the identification of apnea risk, they will be randomized into two groups: one group will undergo the examination via the health department's scheduling system, while the other will do so through primary health care services at the unit closest to their residence.
研究概览
地位
详细说明
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Vinicius Maldaner Vincius Maldaner, PhD
- 电话号码：+ 55 6131078443
- 邮箱：vinicius.silva@unb.br
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- aged 18 years or older;
- present clinical suspicion of OSA, confirmed by screening using the STOP-BANG and Epworth Sleepiness Scale questionnaires;
- be receiving care at Basic Health Units (UBS), or be registered on the Central Regulation waiting list system for polysomnography (PSG);
Exclusion Criteria:
- use of home oxygen therapy;
- use of invasive or non-invasive mechanical ventilation;
- use of a tracheostomy;
- change of residence during the data collection period;
- known allergy to materials used in sleep monitoring equipment.
学习计划
研究是如何设计的？
设计细节
- 主要用途：诊断
- 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 care
The home polysomnography made by health professionals in primary care, and patients diagnosed with moderate to severe sleep apnea will be delivered to the unit closer to your house.
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Participants will undergo diagnostic screening using the STOP-BANG and Epworth questionnaires; following the identification of apnea risk will undergo a home polysomnography through primary health care services at the unit closest to their residence.
其他名称：
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有源比较器：Standard protocol
The polysomnography made by a reference center in a public hospital, when the patients have to sleep in a hospital ward after they are invited by the regulatory system fo the health system
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The patients undergo the polysomnography via the health department's scheduling system
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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incremental cost-effectiveness ratio (ICER)
大体时间：baseline from 6 months
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The ICER will be calculated by: Costs of primary care - Cost of the standard intervention)/(Effect of primary care - Effect of the standard intervention, where the effect be assessed by the time to the patients get the full diagnosis.
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baseline from 6 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Satisfaction level
大体时间：6 months
|
Satisfaction level of each participant enrolled to do polysomnography evaluated by PCAtool in primary care or standard protocol
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6 months
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Apnea-hypopnea Index (AHI)
大体时间：6 months
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To assess the diagnostic validity of a primary care home polysomnography compared with the standard polysomnography (PSG) in adults with clinically suspected Obstructive Sleep Apnea (OSA), based on the results of the Apnea-hypopnea Index (AHI).
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6 months
|
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Time to full diagnosis
大体时间：Baseline to 6 months
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the spent time for the patients to get the full diagnosis of obstructive sleep apnea
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Baseline to 6 months
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合作者和调查者
调查人员
- 首席研究员：Vinicius Maldaner, PhD、University of Brasilia
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
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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