Automate Detection of Sleep Apnea by ApneascanTM (AIRLESS)

Grenoble Alpes University Hospital Center (CHU)

Status and phase: Completed; Phase 4

Conditions: Arrhythmias; Sleep Apnea

Treatments: Other: Apneascan TM; Device: Polysomnography/polygraphy

Study type: Interventional

Funder types: Other

Identifiers

NCT02045173

1332

Details and patient eligibility

About

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 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.

Enrollment: 41 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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41 participants in 1 patient group

Apneascan TM

Other group

Description:

autoscoring algorithms of the Apneascan TM compared to the polysomnography or polygraphy

Treatment:

Device: Polysomnography/polygraphy

Other: Apneascan TM