Noise, a Risk for Heart in Airplane Pilots

Pericarditis Clinical Trial

Official title:

Noise of Airplanes a Factor of Risk for the Health of the Heart in Pilots and Crew in Operations of the F16 Airplane

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01063582
• Other study ID #: FMendezV001
• Status: Enrolling by invitation
• Phase: N/A
• First received: February 4, 2010
• Last updated: February 4, 2010
• Start date: February 2005
• Est. completion date: December 2010

Study information

• Verified date: January 2007
• Source: Universidad Politecnica de Madrid
• Contact: n/a
• Is FDA regulated: No
• Health authority: España: Universidad Politecnica de Madrid.
• Study type: Observational

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 16
• Est. completion date: December 2010
• Est. primary completion date: September 2005
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 26 Years to 37 Years

Eligibility

Inclusion Criteria:

• exposure to noise from military aircraft

Exclusion Criteria:

• inactive personal or vacation

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Pericarditis

Intervention

Other:
• exposure to occupational noise
We performed the measurement of occupational noise exposure through sound level meter and Dosimeter during flight operations of F-16 fighter plane.

Procedure:
• cardiovascular valuation
Cardiovascular valuation was performed via electrocardiogram and echocardiographic techniques to correlate the changes observed during exposure to occupational noise

Locations

Country	Name	City	State
Spain	Universidad Politécnica de Madrid	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Politecnica de Madrid

Country where clinical trial is conducted

Spain, 

References & Publications (7)

Andrén L, Lindstedt G, Björkman M, Borg KO, Hansson L. Effect of noise on blood pressure and 'stress' hormones. Clin Sci (Lond). 1982 Feb;62(2):137-41. — View Citation

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.

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

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	left ventricular systolic function		one year	No
Secondary	electrical disturbance of the heart		15 days	No
Secondary	study of the dimensions of cavities of the heart		15 days	No
Secondary	haemodynamic study of the conditions		15 days	No
Secondary	characterization of ambient sound military aero by Sound Level Meter		15 days	No
Secondary	sensitivity analysis of noise dosimetry		15 days	No
Secondary	subjective perception of noise		15 days	No
Secondary	analysis of clinical background for selection of sample subjects		3 months	No