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

NCT02751021 | Completed

• 1 other identifier: 2016-A00034-47
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Apnea; Arrhythmias, Cardiac; Hyperaldosteronism; Cardiac Diastolic Function

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• 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

Study Arms (1)

Sleep apnea diagnosis

OTHER

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; Other: Attended cardiorespiratory sleep study

Interventions

pacemaker diagnostic algorithm OTHER

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

Sleep apnea diagnosis

Attended cardiorespiratory sleep study OTHER

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

Sleep apnea diagnosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Caen: lead
• LivaNova: collaborator

Study Sites (1)

Caen University Hospital

Caen, Normandy, 14000, France

Location

Related Publications (1)

• 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.

  PMID: 29343998 BACKGROUND

MeSH Terms

Conditions

Sleep Apnea Syndromes; Arrhythmias, Cardiac; Hyperaldosteronism

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases

Study Officials

• Laure CHAMP-RIGOT, MD

  University Hospital, Caen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2016
• First Posted: April 26, 2016
• Study Start: June 22, 2016
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: April 2, 2026

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)