Clinical trial NCT02045173: Automate Detection of Sleep Apnea by ApneascanTM
Official 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Sleep Apnea
Arrhythmias
Keywords: Sleep apnea, Arrhythmias, Heart Failure, ICD, CRT-D, Apneascan
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2014-01-24
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Apnea-hypopnea index obtained from polysomnography or polygraphy and from autoscoring algorithms of the ApneaScan™ implantable impedance respiration sensor
timeFrame: Prior the ICD or CRT-D implantation and up to 3 months
Secondary outcomes:
measure: 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
timeFrame: baseline and up to 3 months
measure: Weekly weight readings automatically and wirelessly sent to the LATITUDE(C)
timeFrame: Baseline and Up to 3 months
measure: 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
timeFrame: Prior the ICD or CRT-D implantation and up to 3 months
Other outcomes:
measure: Evolution night by night of AHI obtained from autoscoring algorithms of the ApneaScan™ implantable impedance respiration sensor
timeFrame: From ICD or CRT-D implantation and up to 3 months
Locations:
city: Grenoble
country: France
facility: CHU de Grenoble
city: Montpellier
country: France
facility: Hôpital Arnaud de Villeneuve
city: Nancy
country: France
facility: Hopital Barbois
city: Toulouse
country: France
facility: Clinique Pasteur
city: Tours
country: France
facility: Hôpital Trousseau
Study officials:
affiliation: Grenoble Hospital University
name: Jean Louis PEPIN, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Grenoble Hospital University
name: Pascal DEFAYE, MD
role: PRINCIPAL_INVESTIGATOR
References: