NCT05495347

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 2,500 (estimated)
• Sponsor: Instituto de Investigación Marqués de Valdecilla · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: —

Summary

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.

Conditions

• Obstructive Sleep Apnea
• Positive Airway Pressure

Interventions

Type	Name	Description
OTHER	patients diagnosed with OSA	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.

Timeline

• Start date: 2022-07-01
• Primary completion: 2022-12-31
• Completion: 2022-12-31
• First posted: 2022-08-10
• Last updated: 2022-08-10

Locations

1 site across 1 country: Spain