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

Sleep Apnea Clinical Trial

— SAPAAD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02751021
• Other study ID #: 2016-A00034-47
• Status: Completed
• Phase: N/A
• Start date: June 22, 2016
• Est. completion date: June 2019

Study information

• Verified date: August 2019
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: June 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Arrhythmias, Cardiac
• Cardiac Diastolic Function
• Hyperaldosteronism
• Sleep Apnea
• Sleep Apnea Syndromes

Intervention

Other:
• pacemaker diagnostic algorithm
evaluation of the respiratory disturbance index by measurement of transthoracic impedance variation, to detect sleep apnea
• Attended cardiorespiratory sleep study
sleep study with portable monitor resulting in the apnea hypopnea index, to confirm sleep apnea diagnosis

Locations

Country	Name	City	State
France	Caen University Hospital	Caen	Normandy

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Caen	LivaNova

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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