NCT02116686

ECG Derived Respiration for Automated Screening of Sleep Disordered Breathing in Chronic Heart Failure Patients

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 100 (actual)
• Sponsor: Centre Hospitalier Universitaire de Saint Etienne · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The prevalence of sleep disordered breathing (SDB) reaches more than 50% in chronic heart failure patients (CHF). The main consequence is an increase risk of fatal and non-fatal cardiovascular events. A treatment by continuous positive airway pressure (CPAP) or adaptative servo-ventilation (ASV) reduces this risk. Nevertheless, 75% of severe SDB cases remains undiagnosed and untreated especially due to cost and time delay for polysomnography examination which is the gold standard for SDB diagnosis. Indeed, alternative methods are developed. Some methods, based on nocturnal ECG analysis showed promising results but they are not validated and adapted for cardiac population. Thus, the goal of present study is to test the accuracy of ECG derived respiration signal to screen SDB in a CHF population.

Conditions

• Heart Failure
• Sleep Apnea Syndromes
• Polysomnography

Interventions

Type	Name	Description
DEVICE	ventilatory polygraphic recordings	Standard nocturnal in-home ventilatory polygraphic recordings were performed using an Embla device (Embla®, Broomfield, USA) and scored according to the AASM recommendations (RemLogic® software, Broomfield, USA).

Timeline

• Start date: 2013-06-01
• Primary completion: 2014-11-01
• Completion: 2014-11-01
• First posted: 2014-04-17
• Last updated: 2015-03-31

Locations

2 sites across 1 country: France