Big Data Analysis of OSA Patients on Positive Airway Pressure (PAP) Treatment: Real-life Monitoring

Study Overview
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Brief Summary
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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.

Official Title
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Big Data Analysis of OSA Patients on Positive Airway Pressure (PAP) Treatment: Real-life Monitoring: TeleVAL Study

Conditions
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Obstructive Sleep Apnea, Positive Airway Pressure

Intervention / Treatment
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* Other: patients diagnosed with OSA


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Registry of patients<br> | Other: patients diagnosed with OSA<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characterize the phenotypes involved | Determine the emergent CSA appearance in relation to PAP treatment. | pandemic start date March 2020 until December 2022. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Establish the percentage of patients who at the first connection to the TM achieved the optimal therapeutic pressure | According to Built in software (BIS) of the equipment | 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 | According to Built in software (BIS) of the equipment | pandemic start date March 2020 until December 2022. | 
| Variations in AHI during the first year of follow-up and their relationship with patient characteristics. |  | pandemic start date March 2020 until December 2022. | 
| Time to achieve the optimal therapeutic pressure described after the first connection | Number of modifications required and their relationship with patient subgroups. | pandemic start date March 2020 until December 2022. | 
| Evaluation of the impact of long-term telemonitoring of patients with OSA | Number of acesses and interventions made to the telemonitoring platform/year and time invested | pandemic start date March 2020 until December 2022. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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telemonitoring, big data