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| Name | Class |
|---|---|
| LivaNova | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sleep apnea diagnosis | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pacemaker diagnostic algorithm | Other | evaluation of the respiratory disturbance index by measurement of transthoracic impedance variation, to detect sleep apnea |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 2 months after pacemaker implantation |
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of plasmatic aldosterone and correlation with apnea hypopnea index | 2 months after pacemaker implantation and one month after the beginning of continuous positive airway pressure (CPAP) therapy in apneic patients |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laure CHAMP-RIGOT, MD | University Hospital, Caen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Caen University Hospital | Caen | Normandy | 14000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29343998 | Background | Champ-Rigot L, Ferchaud V, Prevost JN, Moirot P, Pellissier A, Legallois D, Alexandre J, Scanu P, Morello R, Saloux E, Milliez PU. Rationale and Design for a Monocentric Prospective Study: Sleep Apnea Diagnosis Using a Novel Pacemaker Algorithm and Link With Aldosterone Plasma Level in Patients Presenting With Diastolic Dysfunction (SAPAAD Study). Clin Med Insights Cardiol. 2018 Jan 8;12:1179546817751628. doi: 10.1177/1179546817751628. eCollection 2018. |
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| Attended cardiorespiratory sleep study | Other | sleep study with portable monitor resulting in the apnea hypopnea index, to confirm sleep apnea diagnosis |
|
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001145 | Arrhythmias, Cardiac |
| D006929 | Hyperaldosteronism |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000308 | Adrenocortical Hyperfunction |
| D000307 | Adrenal Gland Diseases |
| D004700 | Endocrine System Diseases |
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