Automate Detection of Sleep Apnea by ApneascanTM

Sleep Apnea Clinical Trial

— AIRLESS  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02045173
• Other study ID #: 1332
• Status: Completed
• Phase: Phase 4
• First received: January 22, 2014
• Last updated: October 19, 2016
• Start date: January 2014
• Est. completion date: October 2016

Study information

• Verified date: October 2016
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Apnea
• Arrhythmias
• Sleep Apnea
• Sleep Apnea Syndromes

Intervention

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

Device:
• Polysomnography/polygraphy
1 night polysomnography/polygraphy

Locations

Country	Name	City	State
France	CHU de Grenoble	Grenoble
France	Hôpital Arnaud de Villeneuve	Montpellier
France	Hopital Barbois	Nancy
France	Clinique Pasteur	Toulouse
France	Hôpital Trousseau	Tours

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Evolution night by night of AHI obtained from autoscoring algorithms of the ApneaScan™ implantable impedance respiration sensor		From ICD or CRT-D implantation and up to 3 months	No
Primary	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	No
Secondary	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	No
Secondary	Weekly weight readings automatically and wirelessly sent to the LATITUDE(C)		Baseline and Up to 3 months	No
Secondary	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	No