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慢性心不全における睡眠時無呼吸の検出のための「ApneaScan」アルゴリズムの検証

基本情報

NCT ID
NCT01979120
ステータス
不明
試験のフェーズ
-
試験タイプ
観察
目標被験者数
200
治験依頼者名
Medical University of Vienna

概要

A prospective observational multi-centre study for the validation of the ApneaScan algorithm (integrated in ICD devices (with or without cardiac resynchronization therapy function) of the "Incepta" series for the screening of sleep disordered breathing in patients with stable symptomatic chronic heart failure, using portable polygraphy monitoring device ("Embletta Gold") as reference for the Apnea-Hypopnea-Index (AHI). Secondary objectives are the detection of severe sleep disordered breathing in patients with clinically indicated in-laboratory polysomnography, as well as correlations of the AHI detected by ApneaScan with other clinical endpoints like mortality, hospitalization, atrial fibrillation and ventricular arrhythmia.

対象疾患

Sleep-disordered BreathingChronic Heart Failure

依頼者(Sponsor)

実施施設 (4)

Juntendo University School of Medicine

Urayasu, Japan(NOT_YET_RECRUITING)

Tottori University

Tottori, Japan(NOT_YET_RECRUITING)

東京医科大学病院

Tokyo, Japan(NOT_YET_RECRUITING)

Kyushu University

Kyushu, Japan(NOT_YET_RECRUITING)