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Completed

NCT Number: NCT02045173

Automate Detection of Sleep Apnea by ApneascanTM

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).

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Key information

Conditions

Sleep Apnea Apnea Arrhythmias Arrhythmias, Cardiac Cardiovascular Diseases Dyssomnias Heart Diseases Heart Failure Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

CHU de Grenoble, Grenoble, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Apneascan TM

Other

Autoscoring algorithms with automatical detection of sleep apnea by the Apneascan TM

Polysomnography/polygraphy

Device

1 night polysomnography/polygraphy

Primary outcomes

  1. 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 outcomes

  1. 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

  2. Weekly weight readings automatically and wirelessly sent to the LATITUDE(C)

    Time frame: Baseline and Up to 3 months

  3. 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

Other outcomes

  1. Evolution night by night of AHI obtained from autoscoring algorithms of the ApneaScan™ implantable impedance respiration sensor

    Time frame: From ICD or CRT-D implantation and up to 3 months

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Official study 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)

Acronym: AIRLESS

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jan 24, 2014
Registry last updated
Oct 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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