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

• Conditions: Obstructive Sleep Apnea; Positive Airway Pressure
• Interventions: Other: patients diagnosed with OSA

• Registration Number: NCT05495347
• Lead Sponsor: Instituto de Investigación Marqués de Valdecilla

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-01
• Status Verified: 2022-08
• Study First Submitted: 2022-08-05
• Study First Submitted QC: 2022-08-08
• Last Update Submitted: 2022-08-08
• Study First Posted: 2022-08-10
• Last Update Posted: 2022-08-10
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Registry of patients	patients diagnosed with OSA	-

Primary Outcome Measures

Name	Time	Method
Characterize the phenotypes involved	pandemic start date March 2020 until December 2022.	Determine the emergent CSA appearance in relation to PAP treatment.

Secondary Outcome Measures

Name	Time	Method
Variations in AHI during the first year of follow-up and their relationship with patient characteristics.	pandemic start date March 2020 until December 2022.
Establish the percentage of patients who at the first connection to the TM achieved the optimal therapeutic pressure	pandemic 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 pressure	pandemic start date March 2020 until December 2022.	According to Built in software (BIS) of the equipment
Time to achieve the optimal therapeutic pressure described after the first connection	pandemic 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 OSA	pandemic start date March 2020 until December 2022.	Number of acesses and interventions made to the telemonitoring platform/year and time invested

Trial Locations

Locations (1)

Hospital Universitario Marques de Valdecilla; 🇪🇸 Santander, Cantabria, Spain