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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05495347
Acronym
TeleVAL
Enrollment
2500
Registered
2022-08-10
Start date
2022-07-01
Completion date
2022-12-31
Last updated
2022-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea, Positive Airway Pressure

Keywords

telemonitoring, big data

Brief 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.

Interventions

OTHERpatients 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.

Sponsors

Instituto de Investigación Marqués de Valdecilla
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL

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

Design outcomes

Primary

MeasureTime frameDescription
Characterize the phenotypes involvedpandemic start date March 2020 until December 2022.Determine the emergent CSA appearance in relation to PAP treatment.

Secondary

MeasureTime frameDescription
Establish the percentage of patients who at the first connection to the TM achieved the optimal therapeutic pressurepandemic start date March 2020 until December 2022.According to Built in software (BIS) of the equipment
Establish the Profile of patients who at the first connection to the TM achieved the optimal therapeutic pressurepandemic start date March 2020 until December 2022.According to Built in software (BIS) of the equipment
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 connectionpandemic start date March 2020 until December 2022.Number of modifications required and their relationship with patient subgroups.
Evaluation of the impact of long-term telemonitoring of patients with OSApandemic start date March 2020 until December 2022.Number of acesses and interventions made to the telemonitoring platform/year and time invested

Countries

Spain

Contacts

Primary Contactmonica Gonzalez
monica.gonzalezm@scsalud.es+34942203389
Backup ContactLucía Lavin
eclinicos5@idival.org+34942203389

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026