Automate Detection of Sleep Apnea by ApneascanTM

Overview

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).

Full Title of Study: “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)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 2016

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

  • Other: Apneascan TM
    • Autoscoring algorithms with automatical detection of sleep apnea by the Apneascan TM
  • Device: Polysomnography/polygraphy
    • 1 night polysomnography/polygraphy

Arms, Groups and Cohorts

  • Other: Apneascan TM
    • autoscoring algorithms of the Apneascan TM compared to the polysomnography or polygraphy

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital, Grenoble
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Jean Louis PEPIN, MD, PhD, Principal Investigator, Grenoble Hospital University
    • Pascal DEFAYE, MD, Principal Investigator, Grenoble Hospital University

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