Big Data Analysis of OSA Patients on Positive Airway Pressure (PAP) Treatment: Real-life Monitoring (TeleVAL)
Big Data Analysis of OSA Patients on Positive Airway Pressure (PAP) Treatment: Real-life Monitoring: TeleVAL Study
The present study aims to determine to what extent remote monitoring of PAP related to patients' clinical parameters is able to provide relevant data on predictors of compliance, subgroups of patients who may benefit from this technological tool, variations in AHI over time, occurrence of central events at the start of therapy and, in short, to shed new light on this disease and its treatment, all within the application of continuous positive pressure therapy in the real world.
Among the intended objectives is the identification of phenotypes involved in the use and efficacy of PAP therapy: development of a predictive model, as well as the evaluation of the impact of long-term telemonitoring of patients with Obstructive Sleep Apnea (OSA).
The study initially arose from the need to diagnose, treat and follow up patients with suspected OSA in compliance with the social distancing rules imposed by the COVID-19 pandemic.
It is an ambispective cohort study, with retrospective data collection from the start date of the pandemic (March 2020) to December 2021, and prospective data collection from the approval of the protocol to December 2022.
研究概览
研究类型
注册 (预期的)
联系人和位置
学习联系方式
- 姓名：monica Gonzalez
- 电话号码：+34942203389
- 邮箱：monica.gonzalezm@scsalud.es
研究联系人备份
- 姓名：Lucía Lavin
- 电话号码：+34942203389
- 邮箱：eclinicos5@idival.org
学习地点
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Cantabria
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Santander、Cantabria、西班牙、39008
- 招聘中
- Hospital Universitario Marqués de Valdecilla
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接触：
- Monica Gonzalez
- 邮箱：monica.gonzalezm@scsalud.es
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参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- All patients diagnosed with OSA since March 2020 with indication for treatment with PAP have been telemonitored on an ongoing basis since initiation of therapy continuing to be telemonitored at the current time.
Exclusion Criteria:
- Undiagnosed OSA patients
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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Registry of patients
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All patients diagnosed with OSA since March 2020 with an indication for treatment with PAP have been telemonitored permanently since the start of therapy and continue to be telemonitored at the present time.
Data are sent remotely daily to the telemonitoring platform.
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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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Characterize the phenotypes involved
大体时间：pandemic start date March 2020 until December 2022.
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Determine the emergent CSA appearance in relation to PAP treatment.
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pandemic start date March 2020 until December 2022.
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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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Establish the percentage of patients who at the first connection to the TM achieved the optimal therapeutic pressure
大体时间：pandemic start date March 2020 until December 2022.
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According to Built in software (BIS) of the equipment
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pandemic start date March 2020 until December 2022.
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Establish the Profile of patients who at the first connection to the TM achieved the optimal therapeutic pressure
大体时间：pandemic start date March 2020 until December 2022.
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According to Built in software (BIS) of the equipment
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pandemic start date March 2020 until December 2022.
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Variations in AHI during the first year of follow-up and their relationship with patient characteristics.
大体时间：pandemic start date March 2020 until December 2022.
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pandemic start date March 2020 until December 2022.
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Time to achieve the optimal therapeutic pressure described after the first connection
大体时间：pandemic start date March 2020 until December 2022.
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Number of modifications required and their relationship with patient subgroups.
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pandemic start date March 2020 until December 2022.
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Evaluation of the impact of long-term telemonitoring of patients with OSA
大体时间：pandemic start date March 2020 until December 2022.
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Number of acesses and interventions made to the telemonitoring platform/year and time invested
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pandemic start date March 2020 until December 2022.
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
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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