Automate Detection of Sleep Apnea by ApneascanTM

Phase 4

Completed

• Conditions: Sleep Apnea; Arrhythmias
• Interventions: Other: Apneascan TM; Device: Polysomnography/polygraphy

• Registration Number: NCT02045173
• Lead Sponsor: University Hospital, Grenoble

Brief 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.

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-01-22
• Study First Submitted QC: 2014-01-22
• Study First Posted: 2014-01-24
• Status Verified: 2016-10
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Last Update Submitted: 2016-10-19
• Last Update Posted: 2016-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Apneascan TM	Apneascan TM	autoscoring algorithms of the Apneascan TM compared to the polysomnography or polygraphy
Apneascan TM	Polysomnography/polygraphy	autoscoring algorithms of the Apneascan TM compared to the polysomnography or polygraphy

Primary Outcome Measures

Name	Time	Method
Apnea-hypopnea index obtained from polysomnography or polygraphy and from autoscoring algorithms of the ApneaScan™ implantable impedance respiration sensor	Prior the ICD or CRT-D implantation and up to 3 months

Secondary Outcome Measures

Name	Time	Method
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	baseline and up to 3 months
Weekly weight readings automatically and wirelessly sent to the LATITUDE(C)	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	Prior the ICD or CRT-D implantation and up to 3 months

Trial Locations

Locations (5)

Hôpital Arnaud de Villeneuve; 🇫🇷 Montpellier, France

CHU de Grenoble; 🇫🇷 Grenoble, France

Hopital Barbois; 🇫🇷 Nancy, France

Clinique Pasteur; 🇫🇷 Toulouse, France

Hôpital Trousseau; 🇫🇷 Tours, France