Healthy IndividualsLÄRMNCT02783456
The Influence of Aircraft Noise Exposure on Renal Hemodynamic in Healthy Individuals
A study testing Noise and Silence in people with Healthy Individuals and Arterial Hypertension, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Individuals, Arterial Hypertension
- What is being tested?
- Noise and Silence
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2016to Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with mild-moderate arterial hypertension (grade 1-2)
- Informed consent in writing available
- Willing and able to comply with all requirements of the study
- Male, between 18 and 50 years (inclusive)
- Body Mass Index (BMI) 18-27 kg/m2
- Non-smoker
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- Good general health as judged by the Investigator, as determined by medical history, physical examination, vital signs (systolic and diastolic blood pressure and pulse rate) and clinical laboratory parameters (clinical chemistry, hematology, and urinalysis).
- 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:
- uncomplicated arterial hypertension WHO grade 1-2, office blood pressure 140-179/90-109 mmHg
Who cannot join
- Clinically significant abnormalities in physical examination, vital signs or clinical laboratory parameters (according to the Investigator's judgement).
- S-GOT or S-GPT levels > 2-times above the upper limit of normal range.
- eGFR < 60 ml/min/1,73m2 or kidney stones
- Clinically significant history of cardiovascular disease or any known present cardiovascular disease.
- History of clinically significant neurological, gastrointestinal, renal, hepatic, psychological, pulmonary, metabolic, endocrine, hematological, or other major disorders.
- Office blood pressure at screening higher than 140/100 mmHg
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- Office heart rate at screening outside the range of 50-99 beats per minute (inclusive).
- Regular intake of medication within 1 month prior to study inclusion
- Participation in any other clinical study within 30 days prior to inclusion in this study.
- Clinically significant diseases (as judged by the investigator) within four weeks prior to screening
- History of alcohol or drug abuse.
- Regular intake of medication within 1 month prior to study inclusion
- office blood pressure at screening visit > 180/110 mmHg
- secondary hypertension application of
- antihypertensive medication within 14 days prior to study inclusion
- of "other" medication
- Clinically significant abnormalities in physical examination, vital signs or clinical laboratory parameters (according to the Investigator's judgement).
- S-GOT or S-GPT levels > 2-times above the upper limit of normal range.
- eGFR < 60 ml/min/1,73m2 or kidney stones
- Clinically significant history of cardiovascular disease or any known present cardiovascular disease other than arterial hypertension.
- History of clinically significant neurological, gastrointestinal, renal, hepatic, psychological, pulmonary, metabolic, endocrine, hematological, or other major disorders, other than arterial hypertension.
- Office heart rate at screening outside the range of 50-99 beats per minute (inclusive).
- Regular intake of medication within 1 month prior to study inclusion
- Participation in any other clinical study within 30 days prior to inclusion in this study.
- Clinically significant diseases (as judged by the investigator) within four weeks prior to screening, other than arterial hypertension.
- History of alcohol or drug abuse.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Healthy Individuals, Arterial Hypertension
- Being tested
- Noise, Silence
- Keywords
- renal hemodynamic, central hemodynamic, pilot study, flight noise, healthy participant, renal plasma flow, filtration fraction, renal vascular resistance, calculated intra glomerular pressure
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NoiseProcedure or surgery
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.
SilenceProcedure or surgery
The patient is exposed 30 min to the second sound pattern and during the renal hemodynamics will be measured.
| Study group | Role | What they receive |
|---|---|---|
| Noise and silence | Active comparator | Exposition of 80dB flight noise for 30 minutes and 30 minutes silence. Receives: Procedure: Noise; Procedure: Silence |
| silence and noise | Active comparator | Exposition of 30 minutes silence.and 80dB flight noise for 30 minutes Receives: Procedure: Noise; Procedure: Silence |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in renal plasma flow (l/min)
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2016 (estimated)
- Study startMar 2016
- Primary completionJan 2018
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Healthy IndividualsStudies of the same condition, open and under way.
- More trials run by University of Erlangen-Nürnberg Medical SchoolThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roland E. Schmieder, Prof. Dr., Principal investigator, University of Erlangen-Nürnberg Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02783456
- Sponsor's protocol ID
- CRCLÄRM2016
- Acronym
- LÄRM
- Status last verified
- Feb 2018
- First submitted
- 27 Apr 2016
- Last updated
- 26 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
A. Jumar, C. Ott, J.M. Harazny, K. Striepe, M.V. Karg, R.E. Schmieder. NEW MODEL TO INVESTIGATE THE INFLUENCE OF AIRCRAFT NOISE IN THE PATHOPHYSIOLOGICAL CONCEPT OF HYPERTENSION J Hypertens 2017;35, e-Supplement 2:e214 PP.15.32
Bosch A, Rauh M, Striepe K, Schiffer M, Schmieder RE, Kannenkeril D. Renal adaptation in pre-obesity patients with hypertension. J Hypertens. 2024 Nov 1;42(11):1958-1965. doi: 10.1097/HJH.0000000000003821. Epub 2024 Jul 19.
PubMed 39248112
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Aircraft Noise Exposure on Renal Hemodynamic in Healthy Individuals
- ClinicalTrials.gov ID
- NCT02783456
- Acronym / sponsor ID
- LÄRM / CRCLÄRM2016
- Conditions
- Healthy Individuals, Arterial Hypertension
- Keywords
- renal hemodynamic, central hemodynamic, pilot study, flight noise, healthy participant, renal plasma flow, filtration fraction, renal vascular resistance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 26 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Noise and silence | Active comparator | Procedure: Noise, Procedure: SilenceExposition of 80dB flight noise for 30 minutes and 30 minutes silence. |
| silence and noise | Active comparator | Procedure: Noise, Procedure: SilenceExposition of 30 minutes silence.and 80dB flight noise for 30 minutes |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Patients with mild-moderate arterial hypertension (grade 1-2)
- Informed consent in writing available
- Willing and able to comply with all requirements of the study
- Male, between 18 and 50 years (inclusive)
- Body Mass Index (BMI) 18-27 kg/m2
Key exclusion criteria (26 listed)
- Clinically significant abnormalities in physical examination, vital signs or clinical laboratory parameters (according to the Investigator's judgement).
- S-GOT or S-GPT levels > 2-times above the upper limit of normal range.
- eGFR < 60 ml/min/1,73m2 or kidney stones
- Clinically significant history of cardiovascular disease or any known present cardiovascular disease.
- History of clinically significant neurological, gastrointestinal, renal, hepatic, psychological, pulmonary, metabolic, endocrine, hematological, or other major disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NoiseThe 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. | Procedure or surgery | Noise and silence, silence and noise |
| SilenceThe patient is exposed 30 min to the second sound pattern and during the renal hemodynamics will be measured. | Procedure or surgery | Noise and silence, silence and noise |
Primary outcome
change in renal plasma flow (l/min)
Time frame: through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2018.
- Results publicationA. Jumar, C. Ott, J.M. Harazny, K. Striepe, M.V. Karg, R.E. Schmieder. NEW MODEL TO INVESTIGATE THE INFLUENCE OF AIRCRAFT NOISE IN THE PATHOPHYSIOLOGICAL CONCEPT OF HYPERTENSION J Hypertens 2017;35, e-Supplement 2:e214 PP.15.32
- Derived from this study: PubMed 39248112Bosch A, Rauh M, Striepe K, Schiffer M, Schmieder RE, Kannenkeril D. Renal adaptation in pre-obesity patients with hypertension. J Hypertens. 2024 Nov 1;42(11):1958-1965. doi: 10.1097/HJH.0000000000003821. Epub 2024 Jul 19.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roland E. Schmieder, Prof. Dr. principal investigator
University of Erlangen-Nürnberg Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Noise and Silence in people with Healthy Individuals and Arterial Hypertension, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in renal plasma flow (l/min) (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02783456, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2018.