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

NCT ID: NCT05495347

Last Updated: 2022-08-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

2500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-07-01

Study Completion Date

2022-12-31

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.

Detailed Description

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Conditions

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Obstructive Sleep Apnea Positive Airway Pressure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Registry of patients

patients diagnosed with OSA

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Instituto de Investigación Marqués de Valdecilla

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hospital Universitario Marques de Valdecilla

Santander, Cantabria, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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monica Gonzalez

Role: CONTACT

+34942203389

Lucía Lavin

Role: CONTACT

+34942203389

Facility Contacts

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Monica Gonzalez

Role: primary

Other Identifiers

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TeleVAL

Identifier Type: -

Identifier Source: org_study_id

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