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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 ApneaScanâ„¢, 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Apneascan TM | Other | autoscoring algorithms of the Apneascan TM compared to the polysomnography or polygraphy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apneascan TM | Other | Autoscoring algorithms with automatical detection of sleep apnea by the Apneascan TM |
|
| Measure | Description | Time Frame |
|---|---|---|
| Apnea-hypopnea index obtained from polysomnography or polygraphy and from autoscoring algorithms of the ApneaScanâ„¢ implantable impedance respiration sensor | Prior the ICD or CRT-D implantation and up to 3 months |
| Measure | Description | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Evolution night by night of AHI obtained from autoscoring algorithms of the ApneaScanâ„¢ implantable impedance respiration sensor | From ICD or CRT-D implantation and up to 3 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean Louis PEPIN, MD, PhD | Grenoble Hospital University | Principal Investigator |
| Pascal DEFAYE, MD | Grenoble Hospital University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Grenoble | Grenoble | France | ||||
| Hôpital Arnaud de Villeneuve |
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| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001145 | Arrhythmias, Cardiac |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
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| ID | Term |
|---|---|
| D017286 | Polysomnography |
| ID | Term |
|---|---|
| D008991 | Monitoring, Physiologic |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Polysomnography/polygraphy | Device | 1 night polysomnography/polygraphy |
|
| 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 |
| Montpellier |
| France |
| Hopital Barbois | Nancy | France |
| Clinique Pasteur | Toulouse | France |
| Hôpital Trousseau | Tours | France |
| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |