Big Data Analysis of OSA Patients on Positive Airway Pressure (PAP) Treatment: Real-life Monitoring (TeleVAL)
Big Data Analysis of OSA Patients on Positive Airway Pressure (PAP) Treatment: Real-life Monitoring: TeleVAL Study
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.
Studie Overzicht
Toestand
Interventie / Behandeling
Studietype
Inschrijving (Verwacht)
Contacten en locaties
Studiecontact
- Naam: monica Gonzalez
- Telefoonnummer: +34942203389
- E-mail: monica.gonzalezm@scsalud.es
Studie Contact Back-up
- Naam: Lucía Lavin
- Telefoonnummer: +34942203389
- E-mail: eclinicos5@idival.org
Studie Locaties
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Cantabria
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Santander, Cantabria, Spanje, 39008
- Werving
- Hospital Universitario Marques de Valdecilla
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Contact:
- Monica Gonzalez
- E-mail: monica.gonzalezm@scsalud.es
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
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Registry of patients
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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.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Characterize the phenotypes involved
Tijdsspanne: pandemic start date March 2020 until December 2022.
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Determine the emergent CSA appearance in relation to PAP treatment.
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pandemic start date March 2020 until December 2022.
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Establish the percentage of patients who at the first connection to the TM achieved the optimal therapeutic pressure
Tijdsspanne: pandemic start date March 2020 until December 2022.
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According to Built in software (BIS) of the equipment
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pandemic start date March 2020 until December 2022.
|
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Establish the Profile of patients who at the first connection to the TM achieved the optimal therapeutic pressure
Tijdsspanne: pandemic start date March 2020 until December 2022.
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According to Built in software (BIS) of the equipment
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pandemic start date March 2020 until December 2022.
|
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Variations in AHI during the first year of follow-up and their relationship with patient characteristics.
Tijdsspanne: pandemic start date March 2020 until December 2022.
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pandemic start date March 2020 until December 2022.
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Time to achieve the optimal therapeutic pressure described after the first connection
Tijdsspanne: pandemic start date March 2020 until December 2022.
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Number of modifications required and their relationship with patient subgroups.
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pandemic start date March 2020 until December 2022.
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Evaluation of the impact of long-term telemonitoring of patients with OSA
Tijdsspanne: pandemic start date March 2020 until December 2022.
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Number of acesses and interventions made to the telemonitoring platform/year and time invested
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pandemic start date March 2020 until December 2022.
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Medewerkers en onderzoekers
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- TeleVAL
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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