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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Obstructive Sleep Apnea; Positive Airway Pressure
• Intervention / Treatment: Other: patients diagnosed with OSA

• Study Type: Observational
• Enrollment (Anticipated): 2500

Contacts and Locations

• Study Contact: Name: monica Gonzalez; Phone Number: +34942203389; Email: monica.gonzalezm@scsalud.es
• Study Contact Backup: Name: Lucía Lavin; Phone Number: +34942203389; Email: eclinicos5@idival.org

Study Locations

• Spain
  • Cantabria
    • Santander, Cantabria, Spain, 39008
      • Recruiting
      • Hospital Universitario Marques de Valdecilla
      • Contact: Monica Gonzalez; Email: monica.gonzalezm@scsalud.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with Obstructive Sleep Apnea (OSA)

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Registry of patients	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Characterize the phenotypes involved	Determine the emergent CSA appearance in relation to PAP treatment.	pandemic start date March 2020 until December 2022.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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	Number of modifications required and their relationship with patient subgroups.	pandemic start date March 2020 until December 2022.
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.

Collaborators and Investigators

• Sponsor: Instituto de Investigación Marqués de Valdecilla

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: August 5, 2022
• First Submitted That Met QC Criteria: August 8, 2022
• First Posted (Actual): August 10, 2022

Study Record Updates

• Last Update Posted (Actual): August 10, 2022
• Last Update Submitted That Met QC Criteria: August 8, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: telemonitoring; big data
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
• Other Study ID Numbers: TeleVAL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No