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

I

Instituto de Investigación Marqués de Valdecilla

Status

Enrolling

Conditions

Obstructive Sleep Apnea
Positive Airway Pressure

Treatments

Other: patients diagnosed with OSA

Study type

Observational

Funder types

Other

Identifiers

NCT05495347
TeleVAL

Details and patient eligibility

About

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.

Enrollment

2,500 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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

Trial design

2,500 participants in 1 patient group

Registry of patients
Treatment:
Other: patients diagnosed with OSA

Trial contacts and locations

1

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Central trial contact

monica Gonzalez; Lucía Lavin

Data sourced from clinicaltrials.gov

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