The purpose of the study is to compare, three months after implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy-defibrillator (CRT-D), the apnea-hypopnea index (AHI) obtained from conventional in-lab NPSG/NPG (AHIPSG) with similar indices obtained from autoscoring algorithms of the ApneaScan™, an implantable impedance-based respiration sensor (AHIAS).
This is a prospective, multi center, phase-IV with blinded analysis and central reading of polysomnography trial. The study is performed in patients with a standard CRT-D or Implantable Cardioverter Defibrillator (ICD) devices indication. A total of 160 subjects will be recruited in France. The study duration is 03 months for each subject.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
41
Autoscoring algorithms with automatical detection of sleep apnea by the Apneascan TM
1 night polysomnography/polygraphy
CHU de Grenoble
Grenoble, France
Hôpital Arnaud de Villeneuve
Montpellier, France
Hopital Barbois
Nancy, France
Clinique Pasteur
Toulouse, France
Hôpital Trousseau
Tours, France
Apnea-hypopnea index obtained from polysomnography or polygraphy and from autoscoring algorithms of the ApneaScan™ implantable impedance respiration sensor
Time frame: Prior the ICD or CRT-D implantation and up to 3 months
Malignant arrhythmogenic events detected daily by the ICD / CRT-D (AF, ES, supraventricular tachycardia, sustained and non sustained ventricular tachycardia, VF) and night by night AHI assessed by the ApneascanTM
Time frame: baseline and up to 3 months
Weekly weight readings automatically and wirelessly sent to the LATITUDE(C)
Time frame: Baseline and Up to 3 months
Apnea and Hypopnea index measured 3 months after ICR or CRT-D implantation compared to the Apnea and Hypopnea index measured at baseline by the polysomnography or polygraphy
Time frame: Prior the ICD or CRT-D implantation and up to 3 months
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