Big Data Analysis of OSA Patients on Positive Airway Pressure (PAP) Treatment: Real-life Monitoring: TeleVAL Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 2,500
- 试验地点
- 1
- 主要终点
- Characterize the phenotypes involved
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Undiagnosed OSA patients
结局指标
主要结局
Characterize the phenotypes involved
时间窗: pandemic start date March 2020 until December 2022.
Determine the emergent CSA appearance in relation to PAP treatment.
次要结局
- Variations in AHI during the first year of follow-up and their relationship with patient characteristics.(pandemic start date March 2020 until December 2022.)
- Establish the percentage of patients who at the first connection to the TM achieved the optimal therapeutic pressure(pandemic start date March 2020 until December 2022.)
- Establish the Profile of patients who at the first connection to the TM achieved the optimal therapeutic pressure(pandemic start date March 2020 until December 2022.)
- Time to achieve the optimal therapeutic pressure described after the first connection(pandemic start date March 2020 until December 2022.)
- Evaluation of the impact of long-term telemonitoring of patients with OSA(pandemic start date March 2020 until December 2022.)