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

NCT05495347 | Unknown

• 1 other identifier: TeleVAL
• Study Type: observational
• Target: 2,500
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea; Positive Airway Pressure

Keywords

telemonitoring; big data

Outcome Measures

Primary Outcomes (1)

• Characterize the phenotypes involved

  Determine the emergent CSA appearance in relation to PAP treatment.

  pandemic start date March 2020 until December 2022.

Secondary Outcomes (5)

• 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.

• 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.

• 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 connection

  pandemic start date March 2020 until December 2022.

• Evaluation of the impact of long-term telemonitoring of patients with OSA

  pandemic start date March 2020 until December 2022.

Study Arms (1)

Registry of patients

Other: patients diagnosed with OSA

Interventions

patients diagnosed with OSA OTHER

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.

Registry of patients

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with Obstructive Sleep Apnea (OSA)

You may qualify if:

• 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.

You may not qualify if:

• Undiagnosed OSA patients

Sponsors & Collaborators

• Instituto de Investigación Marqués de Valdecilla: lead

Study Sites (1)

Hospital Universitario Marques de Valdecilla

Santander, Cantabria, 39008, Spain

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Central Study Contacts

monica Gonzalez

CONTACT

+34942203389; monica.gonzalezm@scsalud.es

Lucía Lavin

CONTACT

+34942203389; eclinicos5@idival.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2022
• First Posted: August 10, 2022
• Study Start: July 1, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: August 10, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)