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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-22

Study Completion Date

2019-06-30

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.

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Detailed Description

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Conditions

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Sleep Apnea Arrhythmias, Cardiac Cardiac Diastolic Function Hyperaldosteronism

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Sleep apnea diagnosis

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.

Group Type OTHER

pacemaker diagnostic algorithm

Intervention Type OTHER

evaluation of the respiratory disturbance index by measurement of transthoracic impedance variation, to detect sleep apnea

Attended cardiorespiratory sleep study

Intervention Type OTHER

sleep study with portable monitor resulting in the apnea hypopnea index, to confirm sleep apnea diagnosis

Interventions

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pacemaker diagnostic algorithm

evaluation of the respiratory disturbance index by measurement of transthoracic impedance variation, to detect sleep apnea

Intervention Type OTHER

Attended cardiorespiratory sleep study

sleep study with portable monitor resulting in the apnea hypopnea index, to confirm sleep apnea diagnosis

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No