Clinical trial NCT05495347: Big Data Analysis of OSA Patients on Positive Airway Pressure (PAP) Treatment: Real-life Monitoring
Official title: Big Data Analysis of OSA Patients on Positive Airway Pressure (PAP) Treatment: Real-life Monitoring: TeleVAL Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Obstructive Sleep Apnea
Positive Airway Pressure
Keywords: telemonitoring
big data
Lead sponsor: Instituto de Investigación Marqués de Valdecilla
Sponsor class: OTHER
First posted: 2022-08-10
Enrollment: 2500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with Obstructive Sleep Apnea (OSA)

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.


Eligibility criteria: 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

Primary outcomes:
measure: Characterize the phenotypes involved
timeFrame: pandemic start date March 2020 until December 2022.
Secondary outcomes:
measure: Establish the percentage of patients who at the first connection to the TM achieved the optimal therapeutic pressure
timeFrame: pandemic start date March 2020 until December 2022.
measure: Establish the Profile of patients who at the first connection to the TM achieved the optimal therapeutic pressure
timeFrame: pandemic start date March 2020 until December 2022.
measure: Variations in AHI during the first year of follow-up and their relationship with patient characteristics.
timeFrame: pandemic start date March 2020 until December 2022.
measure: Time to achieve the optimal therapeutic pressure described after the first connection
timeFrame: pandemic start date March 2020 until December 2022.
measure: Evaluation of the impact of long-term telemonitoring of patients with OSA
timeFrame: pandemic start date March 2020 until December 2022.
Other outcomes:
Locations:
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla
state: Cantabria
Study officials:
References: