Arrhythmias, Sleep Apnea
Conditions
Keywords
Sleep apnea, Arrhythmias, Heart Failure, ICD, CRT-D, Apneascan
Brief summary
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).
Detailed description
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.
Interventions
OTHERApneascan TM
Autoscoring algorithms with automatical detection of sleep apnea by the Apneascan TM
DEVICEPolysomnography/polygraphy
1 night polysomnography/polygraphy
Sponsors
University Hospital, Grenoble
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male and female aged \> 18 years old * Current ICD or CRT-D device-based guidelines indication (for primo-implantation) * patients with optimal recommended medical therapy * Patient willing and able of undergoing the device implant procedure * Patient willing and able of undergoing the LATITUDE® NXT Patient Management system procedure * Patient willing and able to complete the requirements of the study including the signature of the Informed Consent after full explanation of the study by the investigator prior to participation.
Exclusion criteria
* Obstructive lung disease as defined by a FEV1/FVC less than 70% * Obesity hypoventilation syndrome * Treated sleep disorders breathing * Cardiac surgery scheduled or strong likelihood of cardiac surgery 4 months after enrollment * Life expectancy less than 1 year * Inability to complete overnight PSG as defined by the protocol * Patient who are or suspected to be pregnant and or plan to become pregnant * Patient protected by the Law, under guardianship or curators * Concomitant participation in an interventional biomedical research trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Apnea-hypopnea index obtained from polysomnography or polygraphy and from autoscoring algorithms of the ApneaScan™ implantable impedance respiration sensor | Prior the ICD or CRT-D implantation and up to 3 months |
Secondary
| Measure | Time frame |
|---|---|
| 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 | baseline and up to 3 months |
| Weekly weight readings automatically and wirelessly sent to the LATITUDE(C) | 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 | Prior the ICD or CRT-D implantation and up to 3 months |
Other
| Measure | Time frame |
|---|---|
| Evolution night by night of AHI obtained from autoscoring algorithms of the ApneaScan™ implantable impedance respiration sensor | From ICD or CRT-D implantation and up to 3 months |
Countries
France
Outcome results
None listed