NCT02045173

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2014

Typical duration for phase_4

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

January 22, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 24, 2014

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

October 21, 2016

Status Verified

October 1, 2016

Enrollment Period

2.8 years

First QC Date

January 22, 2014

Last Update Submit

October 19, 2016

Conditions

Sleep ApneaArrhythmias

Keywords

Sleep apnea, Arrhythmias, Heart Failure, ICD, CRT-D, Apneascan

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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

Other Outcomes (1)

  • 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

Study Arms (1)

Apneascan TM

OTHER

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

Other: Apneascan TMDevice: Polysomnography/polygraphy

Interventions

Apneascan TMOTHER

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

Apneascan TM
Polysomnography/polygraphyDEVICE

1 night polysomnography/polygraphy

Apneascan TM

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

CHU de Grenoble

Grenoble, France

Location

Hôpital Arnaud de Villeneuve

Montpellier, France

Location

Hopital Barbois

Nancy, France

Location

Clinique Pasteur

Toulouse, France

Location

Hôpital Trousseau

Tours, France

Location

MeSH Terms

Conditions

Sleep Apnea SyndromesArrhythmias, CardiacHeart Failure

Interventions

Polysomnography

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Monitoring, PhysiologicDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Jean Louis PEPIN, MD, PhD

    Grenoble Hospital University

    PRINCIPAL INVESTIGATOR

  • Pascal DEFAYE, MD

    Grenoble Hospital University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2014

First Posted

January 24, 2014

Study Start

January 1, 2014

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

October 21, 2016

Record last verified: 2016-10

Locations

FR(5)