NCT02045173

Automate Detection of Sleep Apnea by ApneascanTM

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)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: University Hospital, Grenoble · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sleep Apnea
• Arrhythmias

Interventions

Type	Name	Description
OTHER	Apneascan TM	Autoscoring algorithms with automatical detection of sleep apnea by the Apneascan TM
DEVICE	Polysomnography/polygraphy	1 night polysomnography/polygraphy

Timeline

• Start date: 2014-01-01
• Primary completion: 2016-10-01
• Completion: 2016-10-01
• First posted: 2014-01-24
• Last updated: 2016-10-21

Locations

5 sites across 1 country: France