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

Not Applicable

Completed

• Conditions: Sleep Apnea; Arrhythmias, Cardiac; Cardiac Diastolic Function; Hyperaldosteronism
• Interventions: Other: pacemaker diagnostic algorithm; Other: Attended cardiorespiratory sleep study

• Registration Number: NCT02751021
• Lead Sponsor: University Hospital, Caen

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-04-11
• Study First Submitted QC: 2016-04-21
• Study First Posted: 2016-04-26
• Study Start: 2016-06-22
• Primary Completion: 2019-06
• Study Completion: 2019-06
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-05
• Last Update Posted: 2019-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sleep apnea diagnosis	Attended cardiorespiratory sleep study	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.
Sleep apnea diagnosis	pacemaker diagnostic algorithm	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Caen University Hospital; 🇫🇷 Caen, Normandy, France