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
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||66 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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
- 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
- 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 ]
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
|Caen University Hospital|
|Caen, Normandy, France, 14000|
|Principal Investigator:||Laure CHAMP-RIGOT, MD||University Hospital, Caen|