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The aim of this prospective single-center study is to evaluate sympathetic nervous system directly measured by microneurography, 24-hour blood pressure, endothelial function, vascular compliance, quality of life and platelet adhesion in patients with sleep apnea syndrome (defined by a complaint of excessive daytime sleepiness, an Epworth sleepiness score>8[10], and an apnea/hypopnea index (AHI>15/h) before and after catheter-based radiofrequency ablation of renal nerve. If the selected patients are treated with CPAP, this therapy should be stable during the whole study time. Primary and secondary end-point will be measured before and 1, 3, 6 and 12 months after renal sympathetic denervation.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention will be done. The study is observational | Other |
| Measure | Description | Time Frame |
|---|---|---|
| Change in sympathetic nervous system activity (burst/min and burst/100 HB) before and after catheter-based radiofrequency ablation | The primary objective of this study is to evaluate sympathetic nervous system activity in patients with sleep apnea syndrome before and 6 and 12 months after catheter-based radiofrequency ablation therapy of the renal sympathetic-nerve system | 6 and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in 24-hour blood pressure (24 hour, day and night mean) before and after catheter-based renal denervation | Change in 24-hour blood pressure (24 hour, day and night mean) before and after catheter-based renal denervation | 1, 3, 6 12 months |
| Change in renal function (creatinin plasma level and GFR CKD-EPI Formula) before and after catheter-based renal denervation |
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Inclusion criteria: We plan to include male or female subjects, age 18-80 with a diagnosis of medium-severe sleep apnea syndrome (defined by symptoms, a complaint of excessive daytime sleepiness, an Epworth sleepiness score >8, and an apnea / hypopnea index >15/h) and a resistant hypertension (systolic blood pressure >140 mmHg or >130 mmHg in patients with type II diabetes or chronic kidney disease, under treatment with three antihypertensive drugs including a diuretic).
If the selected patients are treated with CPAP, this therapy should be stable during the whole study time.
Every patient will be asked for a written informed consent.
Exclusion criteria: - Heart failure (normal ejection fractions on echocardiography and no clinical signs and symptoms of heart failure).
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patients with therapy-resistant arterial hypertension and sleep apnea syndrome
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Luescher, Professor, MD | University Hospital Zurich, Division of Cardiology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Zurich, Division of Cardiology | Zurich | Canton of Zurich | 8091 | Switzerland |
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Change in creatinin plasma level and GFR CKD-EPI Formula before and after catheter-based renal denervation |
| 1, 3, 6, 12 |
| Change in sleep quality, pulse-oximetry, AHI, quality of life and subjective sleepiness with the Epworth sleepiness score before after catheter-based renal denervation | 1, 3, 6 and 12 months |
| Change in 24-hour Holter and heart rate variability, echocardiogramm before and after catheter-based renal denervation | 6 and 12 months |
| Change in vascular function and oxidative stress and inflammation parameters before and after catheter-based renal denervation | Change in vascular function (endothelial function as flow mediated dilatation, arterial stiffness by pulse wave velocity) and oxidative stress and inflammation parameters before and after catheter-based renal denervation | 1, 3, 6, and 12 months |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| 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 |
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