Arrhythmias, Cardiac, Cardiac Diastolic Function, Hyperaldosteronism, Sleep Apnea
Conditions
Brief summary
Little is known about potential relationships between sleep apnea, plasma aldosterone and diastolic dysfunction which is a very frequent finding among patients requiring permanent cardiac pacing. Sleep apnea is often under diagnosed by clinical examination. Confirmation tests are expensive and access is limited. A specific algorithm available in a recent pacemaker allows assessing breathing variations using minute ventilation sensor, with a good agreement between the respiratory disturbance index and polysomnography results for the diagnosis of severe sleep apnea. The purpose of the study is to examine the diagnostic accuracy of a new pacemaker algorithm for the diagnosis of obstructive sleep apnea in patients presenting with diastolic dysfunction. The investigators also aim to highlight a correlation between plasma aldosterone levels and the severity of sleep apnea, with a reversal effect of ventilation therapy in this specific population.
Interventions
OTHERpacemaker diagnostic algorithm
evaluation of the respiratory disturbance index by measurement of transthoracic impedance variation, to detect sleep apnea
OTHERAttended cardiorespiratory sleep study
sleep study with portable monitor resulting in the apnea hypopnea index, to confirm sleep apnea diagnosis
Sponsors
University Hospital, Caen
LivaNova
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* indication for permanent cardiac pacing (third degree atrioventricular block, second degree atrioventricular block mobitz 2 type, symptomatic sinus node dysfunction including brady-tachy form of sick sinus syndrome or bradyarrhythmia) * Diastolic dysfunction diagnosed at the transthoracic echocardiography
Exclusion criteria
* younger than 18 years old * lack of informed consent form * impossibility to fit in the scheduled study plan * indication for cardiac resynchronization or left ventricular ejection fraction lower than 45% * indication for epicardial pacemaker, known severe sleep apnea treated by continuous positive airway pressure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison between respiratory disturbance index recorded the sleep study night and Apnea hypopnea index | 2 months after pacemaker implantation | number of apneas and hypopneas per hour (5 hours recorded by night) evaluated by the pacemaker algorithm during the night of the attended cardiorespiratory sleep study compared to the apnea hypopnea index evaluated by the portable monitor during the attended cardiorespiratory sleep study |
| Comparison between the mean respiratory disturbance index of the last month and Apnea hypopnea index | 2 months after pacemaker implantation | Average value of respiratory disturbance index recorded each night during the last month compared to the apnea hypopnea index evaluated by the portable monitor during the attended cardiorespiratory sleep study |
Secondary
| Measure | Time frame |
|---|---|
| Measurement of plasmatic aldosterone and correlation with apnea hypopnea index | 2 months after pacemaker implantation and one month after the beginning of continuous positive airway pressure (CPAP) therapy in apneic patients |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORLaure CHAMP-RIGOT, MD
University Hospital, Caen
Outcome results
None listed