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

Obstructive Sleep Apnea Clinical Trial

— TeleVAL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05495347
• Other study ID #: TeleVAL
• Status: Recruiting
• Start date: July 1, 2022
• Est. completion date: December 31, 2022

Study information

• Verified date: August 2022
• Source: Instituto de Investigación Marqués de Valdecilla
• Contact: monica Gonzalez
• Phone: +34942203389
• Email: monica.gonzalezm[@]scsalud.es
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2500
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Positive Airway Pressure
• Sleep Apnea, Obstructive

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Spain	Hospital Universitario Marques de Valdecilla	Santander	Cantabria

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Investigación Marqués de Valdecilla

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Characterize the phenotypes involved	Determine the emergent CSA appearance in relation to PAP treatment.	pandemic start date March 2020 until December 2022.
Secondary	Establish the percentage of patients who at the first connection to the TM achieved the optimal therapeutic pressure	According to Built in software (BIS) of the equipment	pandemic start date March 2020 until December 2022.
Secondary	Establish the Profile of patients who at the first connection to the TM achieved the optimal therapeutic pressure	According to Built in software (BIS) of the equipment	pandemic start date March 2020 until December 2022.
Secondary	Variations in AHI during the first year of follow-up and their relationship with patient characteristics.		pandemic start date March 2020 until December 2022.
Secondary	Time to achieve the optimal therapeutic pressure described after the first connection	Number of modifications required and their relationship with patient subgroups.	pandemic start date March 2020 until December 2022.
Secondary	Evaluation of the impact of long-term telemonitoring of patients with OSA	Number of acesses and interventions made to the telemonitoring platform/year and time invested	pandemic start date March 2020 until December 2022.