Clinical trial NCT02751021: Sleep Apnea Diagnosis Using a Novel Pacemaker Algorithm and Link With Aldosterone Plasma Level in Patients Presenting With Diastolic Dysfunction
Official title: Sleep Apnea Diagnosis Using a Novel Pacemaker Algorithm and Link With Aldosterone Plasma Level in Patients Presenting With Diastolic Dysfunction: SAPAAD Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Apnea
Arrhythmias, Cardiac
Cardiac Diastolic Function
Hyperaldosteronism
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
Collaborators: name: LivaNova
First posted: 2016-04-26
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: Comparison between respiratory disturbance index recorded the sleep study night and Apnea hypopnea index
timeFrame: 2 months after pacemaker implantation
measure: Comparison between the mean respiratory disturbance index of the last month and Apnea hypopnea index
timeFrame: 2 months after pacemaker implantation
Secondary outcomes:
measure: Measurement of plasmatic aldosterone and correlation with apnea hypopnea index
timeFrame: 2 months after pacemaker implantation and one month after the beginning of continuous positive airway pressure (CPAP) therapy in apneic patients
Other outcomes:
Locations:
city: Caen
country: France
facility: Caen University Hospital
state: Normandy
Study officials:
affiliation: University Hospital, Caen
name: Laure CHAMP-RIGOT, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Champ-Rigot L, Ferchaud V, Prevost JN, Moirot P, Pellissier A, Legallois D, Alexandre J, Scanu P, Morello R, Saloux E, Milliez PU. Rationale and Design for a Monocentric Prospective Study: Sleep Apnea Diagnosis Using a Novel Pacemaker Algorithm and Link With Aldosterone Plasma Level in Patients Presenting With Diastolic Dysfunction (SAPAAD Study). Clin Med Insights Cardiol. 2018 Jan 8;12:1179546817751628. doi: 10.1177/1179546817751628. eCollection 2018.