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

Caen University Hospital

Status: Completed

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

Treatments: Other: Attended cardiorespiratory sleep study; Other: pacemaker diagnostic algorithm

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02751021

2016-A00034-47

Details and patient eligibility

About

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.

Enrollment: 66 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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66 participants in 1 patient group

Sleep apnea diagnosis

Other group

Description:

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.

Treatment:

Other: Attended cardiorespiratory sleep study

Other: pacemaker diagnostic algorithm