- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01063582
Noise, a Risk for Heart in Airplane Pilots
Noise of Airplanes a Factor of Risk for the Health of the Heart in Pilots and Crew in Operations of the F16 Airplane
Study of noise generated by military-type aircraft and equipment maintenance in relation to non-auditory effects that impact with the body of the crew and ground staff can cause cardiac pathologies
Hypothesis of work: The pilots and the technical personnel of maintenance that work before the exhibition of noise generated by planes hunt F-16, or equipments of maintenance of the same ones, present major risk of a cardiac affectation, which demonstrates in changes in the normal pace of the heart, in his function of bomb or in hemodynamic conditions.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The work area military airport is characterized by low frequency noise in sound pressure levels exceeding 100 dB, smashing into the body of pilots and ground staff.
It found variations in the thickness of the pericardium and deviation measures ejection fraction
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Madrid, Spain, 28006
- Universidad Politecnica de Madrid
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- exposure to noise from military aircraft
Exclusion Criteria:
- inactive personal or vacation
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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fighter pilots f-16
This group is made up of pilots from the F-16 Venezuelan military air force stationed in the Base Vicente Landaeta Gil de Barquisimeto, Lara State.
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We performed the measurement of occupational noise exposure through sound level meter and Dosimeter during flight operations of F-16 fighter plane.
Other Names:
Cardiovascular valuation was performed via electrocardiogram and echocardiographic techniques to correlate the changes observed during exposure to occupational noise
Other Names:
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aircraft maintenance personnel f-16
Staff responsible for the preparation of aircraft for the flight and maintenance in the hangar at the airbase Vicente Landaeta Gil de Barquisimeto, Lara.
Venezuela
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We performed the measurement of occupational noise exposure through sound level meter and Dosimeter during flight operations of F-16 fighter plane.
Other Names:
Cardiovascular valuation was performed via electrocardiogram and echocardiographic techniques to correlate the changes observed during exposure to occupational noise
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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left ventricular systolic function
Time Frame: one year
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one year
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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electrical disturbance of the heart
Time Frame: 15 days
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15 days
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study of the dimensions of cavities of the heart
Time Frame: 15 days
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15 days
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haemodynamic study of the conditions
Time Frame: 15 days
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15 days
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characterization of ambient sound military aero by Sound Level Meter
Time Frame: 15 days
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15 days
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sensitivity analysis of noise dosimetry
Time Frame: 15 days
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15 days
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subjective perception of noise
Time Frame: 15 days
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15 days
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analysis of clinical background for selection of sample subjects
Time Frame: 3 months
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3 months
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Collaborators and Investigators
Investigators
- Principal Investigator: Fredesvinda M Méndez, MSc, Universidad Politecnica de Madrid
- Study Director: Manuel Recuero, PhD, Universidad Politecnica de Madrid
Publications and helpful links
General Publications
- Jarup L, Babisch W, Houthuijs D, Pershagen G, Katsouyanni K, Cadum E, Dudley ML, Savigny P, Seiffert I, Swart W, Breugelmans O, Bluhm G, Selander J, Haralabidis A, Dimakopoulou K, Sourtzi P, Velonakis M, Vigna-Taglianti F; HYENA study team. Hypertension and exposure to noise near airports: the HYENA study. Environ Health Perspect. 2008 Mar;116(3):329-33. doi: 10.1289/ehp.10775. Erratum In: Environ Health Perspect. 2008 Jun;116(6):A241.
- Andren L, Lindstedt G, Bjorkman M, Borg KO, Hansson L. Effect of noise on blood pressure and 'stress' hormones. Clin Sci (Lond). 1982 Feb;62(2):137-41. doi: 10.1042/cs0620137.
- ISO 1990 - International Organization for Standardization. Acoustics-Determination of occupational noise exposure and estimation of noise-induced hearing impairment. ISO 1999:1990 (E) Geneva ISO 1990
- ISO 1970 -International Organization for Standardization. Acoustics- Guide to international standards on the measurement of airborne acoustical noise and evaluation of its effects on human beings. ISO 2204-70 (E) Geneva ISO 1970.
- Rosenstock, L. Criteria for a recommended standard: occupational noise exposure. National Institute for Occupational Safety and Health. NIOSH, publication June 1998. 98-126.
- Tomei F, De Sio S, Tomao E, Anzelmo V, Baccolo TP, Ciarrocca M, Cherubini E, Valentini V, Capozzella A, Rosati MV. Occupational exposure to noise and hypertension in pilots. Int J Environ Health Res. 2005 Apr;15(2):99-106. doi: 10.1080/09603120500061534.
- Tomei F, Papaleo B, Baccolo TP, Tomao E, Alfi P, Fantini S. [Chronic noise exposure and the cardiovascular system in aircraft pilots]. Med Lav. 1996 Sep-Oct;87(5):394-410. Italian.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FMendezV001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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