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

NCT02751021 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2026-04-02

No results posted yet for this study

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

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

Sponsors & Collaborators

  • LivaNova

    collaborator INDUSTRY

  • University Hospital, Caen

    lead OTHER

Principal Investigators

  • Laure CHAMP-RIGOT, MD · University Hospital, Caen

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-22
Primary Completion
2019-06-30
Completion
2019-06-30

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02751021 on ClinicalTrials.gov