NCT02751021

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: University Hospital, Caen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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
• Cardiac Diastolic Function
• Hyperaldosteronism

Interventions

Type	Name	Description
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

Timeline

• Start date: 2016-06-22
• Primary completion: 2019-06-01
• Completion: 2019-06-01
• First posted: 2016-04-26
• Last updated: 2026-04-02

Locations

1 site across 1 country: France