An observational study in Obstructive Sleep Apnea and Positive Airway Pressure, sponsored by Instituto de Investigación Marqués de Valdecilla. Status unknown at 1 site in Spain. Per ClinicalTrials.gov, last updated 2022-08-10.
Sponsored by Instituto de Investigación Marqués de Valdecilla · Observational
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.
2,198 studies on the registry are indexed under Sleep Apnea, Obstructive; 469 are open to participants now.
This study's planned enrollment of 2,500 is above the median of 104 across 648 observational studies indexed under Sleep Apnea, Obstructive.
Browse Sleep Apnea, Obstructive studies →Instituto de Investigación Marqués de Valdecilla is the lead sponsor of 32 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients diagnosed with Obstructive Sleep Apnea (OSA)
Exclusion Criteria:
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.
Characterize the phenotypes involved
Determine the emergent CSA appearance in relation to PAP treatment.
Time frame: 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
According to Built in software (BIS) of the equipment
Time frame: 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
Time frame: pandemic start date March 2020 until December 2022.
Variations in AHI during the first year of follow-up and their relationship with patient characteristics.
Time frame: 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.
Time frame: 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
Time frame: pandemic start date March 2020 until December 2022.
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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Instituto de Investigación Marqués de Valdecilla