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Automate Detection of Sleep Apnea by ApneascanTM (AIRLESS)

Primary Purpose

Sleep Apnea, Arrhythmias

Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Apneascan TM
Polysomnography/polygraphy
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Sleep Apnea focused on measuring Sleep apnea, Arrhythmias, Heart Failure, ICD, CRT-D, Apneascan

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • CHU de Grenoble
  • Hôpital Arnaud de Villeneuve
  • Hopital Barbois
  • Clinique Pasteur
  • Hôpital Trousseau

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Apneascan TM

Arm Description

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

Outcomes

Primary Outcome Measures

Apnea-hypopnea index obtained from polysomnography or polygraphy and from autoscoring algorithms of the ApneaScan™ implantable impedance respiration sensor

Secondary Outcome Measures

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

Full Information

First Posted
January 22, 2014
Last Updated
October 19, 2016
Sponsor
University Hospital, Grenoble
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1. Study Identification

Unique Protocol Identification Number
NCT02045173
Brief Title
Automate Detection of Sleep Apnea by ApneascanTM
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea, Arrhythmias
Keywords
Sleep apnea, Arrhythmias, Heart Failure, ICD, CRT-D, Apneascan

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Apneascan TM
Arm Type
Other
Arm Description
autoscoring algorithms of the Apneascan TM compared to the polysomnography or polygraphy
Intervention Type
Other
Intervention Name(s)
Apneascan TM
Intervention Description
Autoscoring algorithms with automatical detection of sleep apnea by the Apneascan TM
Intervention Type
Device
Intervention Name(s)
Polysomnography/polygraphy
Intervention Description
1 night polysomnography/polygraphy
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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
Title
Weekly weight readings automatically and wirelessly sent to the LATITUDE(C)
Time Frame
Baseline and Up to 3 months
Title
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 Pre-specified Outcome Measures:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean Louis PEPIN, MD, PhD
Organizational Affiliation
Grenoble Hospital University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pascal DEFAYE, MD
Organizational Affiliation
Grenoble Hospital University
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Grenoble
City
Grenoble
Country
France
Facility Name
Hôpital Arnaud de Villeneuve
City
Montpellier
Country
France
Facility Name
Hopital Barbois
City
Nancy
Country
France
Facility Name
Clinique Pasteur
City
Toulouse
Country
France
Facility Name
Hôpital Trousseau
City
Tours
Country
France

12. IPD Sharing Statement

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Automate Detection of Sleep Apnea by ApneascanTM

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