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
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)