An interventional study of Noise and Silence in Healthy Individuals and Arterial Hypertension, sponsored by University of Erlangen-Nürnberg Medical School. Completed at 1 site in Germany. Open to male participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-02-26.
Sponsored by University of Erlangen-Nürnberg Medical School · Not applicable, Interventional, and Diagnostic
Epidemiological studies have found a link between aircraft noise exposure and increased incidence of arterial hypertension and thus cardiovascular disease. The underlying pathophysiological mechanisms are not yet fully understood. The kidney acts as a long-term regulator of blood pressure and controls the extracellular sodium and water balance. Significant renal mechanisms of blood pressure regulation are the renin angiotensin system, renal sympathetic activity and sodium excretion. Animal work and clinical studies show that mental stress affects the renal plasma flow and urinary sodium excretion. The investigators observed a lower sodium excretion in situations of mental stress in subjects at risk for developing arterial hypertension. In healthy volunteers, a 30-minute mental stress test resulted in increased glomerular filtration rate, filtration fraction and an increase in urinary sodium excretion. In this pilot study the investigators analyzed the influence of 30 minutes standardized aircraft noise on renal and central hemodynamics.
The World Health Organisation (WHO) estimates that (about 340 million population) 1 million annually health life years are lost by environmental noise exposure in high-income countries of Western Europe. Aircraft noise is thereby assessed at comparable volume as unpleasant as road and rail noise. Epidemiological studies have found a link between aircraft noise exposure and increased incidence of arterial hypertension and thus cardiovascular disease. The underlying pathophysiological mechanisms are not yet fully understood.
The kidney acts as a long-term regulator of blood pressure and controls the extracellular sodium and water balance. Significant renal mechanisms of blood pressure regulation are the renin angiotensin system, renal sympathetic activity and sodium excretion. Animal work and clinical studies show that mental stress affects the renal plasma flow and urinary sodium excretion. In spontaneously hypertensive rats environmental stress resulted in sodium retention, triggered by increased renal sympathetic nerve activity, which is the development of arterial hypertension. In a pilot study in subjects at risk for developing arterial hypertension, the investigator observed a lower sodium excretion by mental stress. In healthy volunteers, a 30-minute mental stress test resulted in increased glomerular filtration rate, filtration fraction and an increase in urinary sodium excretion.
In the rabbit noise exposure leads to an increase of frequency and amplitude of discharges of renal sympathetic nerve activity and accompanied by a reduction of renal plasma flow. The impact of aircraft noise on renal plasma flow and urinary sodium excretion has, to our knowledge, so far not been studied in humans.
In this pilot study the Clinical Research Center investigate the influence of 30 minutes standardized aircraft noise on renal hemodynamics.
Hemodynamic renal changes should be considered in the context of the systemic circulation. Therefore, the central hemodynamics is determined in the present pilot study by bioimpedance cardiography.
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This study's enrollment of 86 is close to the median of 90 across 4,995 interventional studies indexed under Hypertension.
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Minor deviations of laboratory values, ECG, and vital sign parameters from the normal range may be accepted, if judged by the Investigator to have no clinical relevance.
Additional inclusion criteria for the cohort with arterial hypertension:
Exclusion Criteria for healthy individuals:
Exclusion criteria for patients with arterial hypertension:
Exposition of 80dB flight noise for 30 minutes and 30 minutes silence.
Procedure: Noise · Procedure: Silence
Exposition of 30 minutes silence.and 80dB flight noise for 30 minutes
Procedure: Noise · Procedure: Silence
The patient is exposed 30 min to the first sound pattern and during the renal hemodynamics will be measured. The following is a 1-hour break.
The patient is exposed 30 min to the second sound pattern and during the renal hemodynamics will be measured.
change in renal plasma flow (l/min)
Time frame: through study completion, an average of 1 year
Plan to share: No
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University of Erlangen-Nürnberg Medical School