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

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

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.

Study Overview

• Status: Completed
• Conditions: Arrhythmias, Cardiac; Sleep Apnea; Hyperaldosteronism; Cardiac Diastolic Function
• Intervention / Treatment: Other: pacemaker diagnostic algorithm; Other: Attended cardiorespiratory sleep study

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Normandy
    • Caen, Normandy, France, 14000
      • CAEN University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	Other: pacemaker diagnostic algorithm; evaluation of the respiratory disturbance index by measurement of transthoracic impedance variation, to detect sleep apnea; Other: Attended cardiorespiratory sleep study; sleep study with portable monitor resulting in the apnea hypopnea index, to confirm sleep apnea diagnosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital, Caen
• Collaborators: LivaNova
• Investigators: Principal Investigator: Laure CHAMP-RIGOT, MD, University Hospital, Caen

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 22, 2016
• Primary Completion (Actual): June 1, 2019
• Study Completion (Actual): June 1, 2019

Study Registration Dates

• First Submitted: April 11, 2016
• First Submitted That Met QC Criteria: April 21, 2016
• First Posted (Estimate): April 26, 2016

Study Record Updates

• Last Update Posted (Actual): August 7, 2019
• Last Update Submitted That Met QC Criteria: August 5, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Endocrine System Diseases; Signs and Symptoms, Respiratory; Adrenocortical Hyperfunction; Adrenal Gland Diseases; Sleep Apnea Syndromes; Apnea; Arrhythmias, Cardiac; Hyperaldosteronism
• Other Study ID Numbers: 2016-A00034-47

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO