Sleep Apnea Diagnosis Using a Novel Pacemaker Algorithm and Link With Aldosterone Plasma Level in Patients Presenting With Diastolic Dysfunction

Study Overview
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Brief Summary
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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.

Official Title
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Sleep Apnea Diagnosis Using a Novel Pacemaker Algorithm and Link With Aldosterone Plasma Level in Patients Presenting With Diastolic Dysfunction: SAPAAD Study

Conditions
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Sleep Apnea, Arrhythmias, Cardiac, Cardiac Diastolic Function, Hyperaldosteronism

Intervention / Treatment
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* Other: pacemaker diagnostic algorithm
* Other: Attended cardiorespiratory sleep study


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Sleep apnea diagnosis<br>The intervention is the use of the pacemaker diagnostic algorithm named Sleep Apnea Monitoring to detect sleep apnea and the attended cardiorespiratory sleep study to confirm the diagnostic. | Other: pacemaker diagnostic algorithm<br>* evaluation of the respiratory disturbance index by measurement of transthoracic impedance variation, to detect sleep apnea<br>Other: Attended cardiorespiratory sleep study<br>* sleep study with portable monitor resulting in the apnea hypopnea index, to confirm sleep apnea diagnosis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison between respiratory disturbance index recorded the sleep study night and Apnea hypopnea index | 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 | 2 months after pacemaker implantation | 
| Comparison between the mean respiratory disturbance index of the last month and Apnea hypopnea index | 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 | 2 months after pacemaker implantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |