Evaluation of the Performances of the Sleep Disordered Breathing Monitoring Function in Pacemaker (DREAM)

July 16, 2013 updated by: LivaNova
The IBSY04 clinical investigation is an European, prospective, multi-centre, non-randomized, longitudinal study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to assess the performance of Sleep Disordered Breathing Monitoring function (SDB) in pacemakers by comparing device diagnostic data to the results of in-lab PolySomnoGraphy (PSG) recording during the same night

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Creteil, France
      • Grenoble, France
      • La Rochelle, France
  • Spain
      • Barcelona, Spain
      • Sevilla, Spain

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria: Any patient enrolled in the study must fulfil all of the following criteria:

  • Patients eligible for implantation of a single or dual-chamber pacemaker according to current available guidelines
  • Patients who are scheduled for implant of a REPLY 200 SR; or REPLY 200 DR pacemaker
  • Patients who provide signed and dated informed consent

Exclusion Criteria:

  • Inability to understand the purpose of the study or refusal to co-operate
  • Unavailability for scheduled follow-ups at the implanting centre
  • Already included in another clinical study that could affect the results of this study
  • Inability or refusal to provide informed consent
  • Patient is minor (less than 18-years old)
  • Patient is pregnant (women of childbearing potential should have a negative pregnancy test prior to enrolment)
  • Patient is forfeiture of freedom or under guardianship

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: REPLY 200 implanted patients
Device: REPLY 200
REPLY 200 pacemaker

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Event-based sensitivity of breathing troubles
Time Frame: 1 day
Evaluation of this outcome requires measuring the number of ventilation pauses and ventilation reductions detected during the same night using SDB Monitoring function or the reference in-lab PSG (clinical assessment).
1 day
Event-based Positive Predictive Value of breathing troubles
Time Frame: 1 day
The Event-based Positive Predictive Value (PPV)of breathing troubles is complementary to Sensitivity. It is the proportion of abnormal events appropriately detected by SDB Monitoring function compared to the total number of abnormal events detected by SDB Monitoring function.
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Apnea Index-based Positive Predictive Value
Time Frame: 1 day
The objective is to assess the Positive Prédictive Value of the SDB Monitoring function based on RDI stored in the pacemaker and the AHI derived from in-lab Polysomnography during the same night.
1 day
Apnea Index-based Negative Predictive Value
Time Frame: 1 day
The objective is to assess the NPV of the SDB Monitoring function based on RDI stored in the pacemaker or the AHI derived from in-lab Polysomnography during the same night.
1 day
Safety based on Adverse events
Time Frame: 3 months
The objective will allow to assess the safety with the summarize all adverse events through 3-month follow-up related to the implant procedure and pacing system or related to any other cause.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LivaNova

Investigators

  • Principal Investigator: PASCAL DEFAYE, Dr, CHU Grenoble, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

February 17, 2012

First Submitted That Met QC Criteria

February 17, 2012

First Posted (Estimate)

February 23, 2012

Study Record Updates

Last Update Posted (Estimate)

July 17, 2013

Last Update Submitted That Met QC Criteria

July 16, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IBSY04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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