An interventional study of pacemaker diagnostic algorithm and Attended cardiorespiratory sleep study in Sleep Apnea, Arrhythmias, Cardiac and Cardiac Diastolic Function, sponsored by University Hospital, Caen. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-02.
Sponsored by University Hospital, Caen · Not applicable, Interventional, and Diagnostic
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.
2,162 studies on the registry are indexed under Sleep Apnea Syndromes; 290 are open to participants now.
This study's enrollment of 66 is above the median of 53 across 1,386 interventional studies indexed under Sleep Apnea Syndromes.
Browse Sleep Apnea Syndromes studies →University Hospital, Caen is the lead sponsor of 505 studies on the registry; 80 are open to participants now.
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Exclusion Criteria:
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
evaluation of the respiratory disturbance index by measurement of transthoracic impedance variation, to detect sleep apnea
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
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
Time frame: 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
Time frame: 2 months after pacemaker implantation
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
Plan to share: No
This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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University Hospital, Caen