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

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ClinicalTrials.gov Identifier: NCT02751021
Recruitment Status : Completed
First Posted : April 26, 2016
Last Update Posted : August 7, 2019
Sponsor:
Collaborator:
LivaNova
Information provided by (Responsible Party):
University Hospital, Caen

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.


Condition or disease Intervention/treatment Phase
Sleep Apnea Arrhythmias, Cardiac Cardiac Diastolic Function Hyperaldosteronism Other: pacemaker diagnostic algorithm Other: Attended cardiorespiratory sleep study Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Sleep Apnea Diagnosis Using a Novel Pacemaker Algorithm and Link With Aldosterone Plasma Level in Patients Presenting With Diastolic Dysfunction: SAPAAD Study
Actual Study Start Date : June 22, 2016
Actual Primary Completion Date : June 2019
Actual Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea
Drug Information available for: Aldosterone

Arm Intervention/treatment
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




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02751021


Locations
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France
Caen University Hospital
Caen, Normandy, France, 14000
Sponsors and Collaborators
University Hospital, Caen
LivaNova
Investigators
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Principal Investigator: Laure CHAMP-RIGOT, MD University Hospital, Caen

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital, Caen
ClinicalTrials.gov Identifier: NCT02751021     History of Changes
Other Study ID Numbers: 2016-A00034-47
First Posted: April 26, 2016    Key Record Dates
Last Update Posted: August 7, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Arrhythmias, Cardiac
Hyperaldosteronism
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Adrenocortical Hyperfunction
Adrenal Gland Diseases
Endocrine System Diseases