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NCT Number: NCT02751021

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

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.

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Key information

Conditions

Sleep Apnea Adrenal Gland Diseases Adrenocortical Hyperfunction Apnea Arrhythmias, Cardiac Cardiac Diastolic Function Cardiovascular Diseases Dyssomnias Endocrine System Diseases Heart Diseases Hyperaldosteronism Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Caen University Hospital

Caen, Normandy, 14000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pacemaker diagnostic algorithm

Other

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

Attended cardiorespiratory sleep study

Other

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

Primary outcomes

  1. Comparison between respiratory disturbance index recorded the sleep study night and Apnea hypopnea index

    Time frame: 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

  2. Comparison between the mean respiratory disturbance index of the last month and Apnea hypopnea index

    Time frame: 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 outcomes

  1. Measurement of plasmatic aldosterone and correlation with apnea hypopnea index

    Time frame: 2 months after pacemaker implantation and one month after the beginning of continuous positive airway pressure (CPAP) therapy in apneic patients

Sponsors and collaborators

Lead sponsor

University Hospital, Caen

Other

Collaborators

  • LivaNova

Registry information

Official study title

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

Acronym: SAPAAD

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Apr 26, 2016
Registry last updated
Apr 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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