Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2026-02-20 @ 2:16 AM
Study NCT ID:
NCT02783456
Status:
COMPLETED
Last Update Posted:
2018-02-26
First Post:
2016-04-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Influence of Aircraft Noise Exposure on Renal Hemodynamic in Healthy Individuals
Sponsor:
University of Erlangen-Nürnberg Medical School
Organization:
Study Overview
Official Title:
The Influence of Aircraft Noise Exposure on Renal Hemodynamic in Healthy Individuals
Status:
COMPLETED
Status Verified Date:
2018-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LÄRM
Brief Summary:
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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: