Evaluation of the Performances of the Sleep Disordered Breathing Monitoring Function in Pacemaker (DREAM)
|ClinicalTrials.gov Identifier: NCT01537718|
Recruitment Status : Completed
First Posted : February 23, 2012
Last Update Posted : July 17, 2013
|Condition or disease||Intervention/treatment||Phase|
|Bradycardia||Device: REPLY 200||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of the Performances of the Sleep Disordered Breathing Monitoring Function in Pacemaker|
|Study Start Date :||March 2012|
|Actual Primary Completion Date :||November 2012|
|Actual Study Completion Date :||November 2012|
Experimental: REPLY 200 implanted patients
REPLY 200 implanted patients
Device: REPLY 200
REPLY 200 pacemaker
- 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).
- 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.
- 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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01537718
|La Rochelle, France|
|Principal Investigator:||PASCAL DEFAYE, Dr||CHU Grenoble, France|