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.
연구 개요
연구 유형
등록 (예상)
연락처 및 위치
연구 연락처
- 이름: monica Gonzalez
- 전화번호: +34942203389
- 이메일: monica.gonzalezm@scsalud.es
연구 연락처 백업
- 이름: Lucía Lavin
- 전화번호: +34942203389
- 이메일: eclinicos5@idival.org
연구 장소
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Cantabria
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Santander, Cantabria, 스페인, 39008
- 모병
- Hospital Universitario Marques de Valdecilla
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연락하다:
- Monica Gonzalez
- 이메일: monica.gonzalezm@scsalud.es
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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Registry of patients
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Characterize the phenotypes involved
기간: pandemic start date March 2020 until December 2022.
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Determine the emergent CSA appearance in relation to PAP treatment.
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pandemic start date March 2020 until December 2022.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Establish the percentage of patients who at the first connection to the TM achieved the optimal therapeutic pressure
기간: pandemic start date March 2020 until December 2022.
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According to Built in software (BIS) of the equipment
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pandemic start date March 2020 until December 2022.
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Establish the Profile of patients who at the first connection to the TM achieved the optimal therapeutic pressure
기간: pandemic start date March 2020 until December 2022.
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According to Built in software (BIS) of the equipment
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pandemic start date March 2020 until December 2022.
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Variations in AHI during the first year of follow-up and their relationship with patient characteristics.
기간: pandemic start date March 2020 until December 2022.
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pandemic start date March 2020 until December 2022.
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Time to achieve the optimal therapeutic pressure described after the first connection
기간: pandemic start date March 2020 until December 2022.
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Number of modifications required and their relationship with patient subgroups.
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pandemic start date March 2020 until December 2022.
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Evaluation of the impact of long-term telemonitoring of patients with OSA
기간: pandemic start date March 2020 until December 2022.
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Number of acesses and interventions made to the telemonitoring platform/year and time invested
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pandemic start date March 2020 until December 2022.
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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폐쇄성 수면 무호흡증에 대한 임상 시험
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Fujian Shengdi Pharmaceutical Co., Ltd.모병Bstructive sleep apnea (OSA) 및 비만중국