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Automate Detection of Sleep Apnea by ApneascanTM — AIRLESS  

Sleep Apnea Clinical Trial

Official title:
Screening for Sleep-disordered Breathing in Routine Cardiology Practice: Validation of the Apnea + Hypopnea Detection by an Implantable Cardioverter Defibrillator (ICD) or Cardiac Resynchronization Therapy-defibrillator (CRT-D) With Impedance-based Respiration Sensor (ApneaScanTM)

Clinical Trial 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).

Clinical Trial 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. ;

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02045173
Study type Interventional
Source University Hospital, Grenoble
Contact
Status Completed
Phase Phase 4
Start date January 2014
Completion date October 2016
View Details
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