PericarditisNCT01063582
Noise, a Risk for Heart in Airplane Pilots
An observational study of Pericarditis, run by Universidad Politecnica de Madrid at 1 site in Spain.
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… Read more about this study
- Who is it for?
- Ages 26 to 37 years, men only
- Conditions the study is for
- Pericarditis
- What is being tested?
- exposure to occupational noise and cardiovascular valuation
- Type of treatment
- Surgery or procedure
- How many people
- 16 participants
- Where
- 1 siteSpain
- Study dates
- Feb 2005to Dec 2010
- Phase
- Observational
- 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 26 to 37 years
- Men only
- No healthy volunteers
- Adult
Study population: Group of subjects directly exposed to noise from military aircraft F-16 during its operation and maintenance at the airbase Vicente Landaeta Gil de Barquisimeto. Lara. Venezuela
Who may be able to join
- exposure to noise from military aircraft
Who cannot join
- inactive personal or vacation
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Conditions
- Pericarditis
- Being tested
- exposure to occupational noise, cardiovascular valuation
- Keywords
- echocardiogram, electrocardiographic, risk factors, noise
- Medical subject headings
- Pericarditis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exposure to occupational noiseOther
Also called occupational noise generated by aircraft miliary
We performed the measurement of occupational noise exposure through sound level meter and Dosimeter during flight operations of F-16 fighter plane.
cardiovascular valuationProcedure or surgery
Also called cardiovascular study
Cardiovascular valuation was performed via electrocardiogram and echocardiographic techniques to correlate the changes observed during exposure to occupational noise
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: exposure to occupational noise; Procedure: cardiovascular valuation | |
| 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 Receives: Other: exposure to occupational noise; Procedure: cardiovascular valuation |
What is being measured
The primary outcome is the main question the study is designed to answer.
left ventricular systolic function
Measured: one year
Secondary outcomes (7)
electrical disturbance of the heart
Measured: 15 days
study of the dimensions of cavities of the heart
Measured: 15 days
haemodynamic study of the conditions
Measured: 15 days
characterization of ambient sound military aero by Sound Level Meter
Measured: 15 days
sensitivity analysis of noise dosimetry
Measured: 15 days
subjective perception of noise
Measured: 15 days
analysis of clinical background for selection of sample subjects
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2010 (estimated)
- Study startFeb 2005
- Primary completionSep 2005 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for PericarditisStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Politecnica de Madrid
- Sponsor type
- University, hospital or other
- Investigators
- Fredesvinda M Méndez, MSc, Principal investigator, Universidad Politecnica de MadridManuel Recuero, PhD, Study director, Universidad Politecnica de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01063582
- Sponsor's protocol ID
- FMendezV001
- Status last verified
- Jan 2007
- First submitted
- 4 Feb 2010
- Last updated
- 5 Feb 2010
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 18335099Andren 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.
PubMed 7053913ISO 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.
PubMed 16026021Tomei 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.
PubMed 9045028
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01063582
- Acronym / sponsor ID
- FMendezV001
- Conditions
- Pericarditis
- Keywords
- echocardiogram, electrocardiographic, risk factors, noise
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Universidad Politecnica de MadridUniversity, hospital or other
- Study start
- Feb 2005
- Primary completion
- Sep 2005 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 5 Feb 2010 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fighter pilots f-16 | – | Other: exposure to occupational noise, Procedure: cardiovascular valuationThis 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. |
| aircraft maintenance personnel f-16 | – | Other: exposure to occupational noise, Procedure: cardiovascular valuationStaff responsible for the preparation of aircraft for the flight and maintenance in the hangar at the airbase Vicente Landaeta Gil de Barquisimeto, Lara. Venezuela |
Who may qualify
- Ages
- 26 to 37 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Group of subjects directly exposed to noise from military aircraft F-16 during its operation and maintenance at the airbase Vicente Landaeta Gil de Barquisimeto. Lara. Venezuela
Key inclusion criteria (1 listed)
- exposure to noise from military aircraft
Key exclusion criteria (1 listed)
- inactive personal or vacation
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 |
|---|---|---|
| exposure to occupational noiseAlso: occupational noise generated by aircraft miliaryWe performed the measurement of occupational noise exposure through sound level meter and Dosimeter during flight operations of F-16 fighter plane. | Other | aircraft maintenance personnel f-16, fighter pilots f-16 |
| cardiovascular valuationAlso: cardiovascular studyCardiovascular valuation was performed via electrocardiogram and echocardiographic techniques to correlate the changes observed during exposure to occupational noise | Procedure or surgery | aircraft maintenance personnel f-16, fighter pilots f-16 |
Primary outcome
left ventricular systolic function
Time frame: one year
7 secondary outcomes
electrical disturbance of the heart
Time frame: 15 days
study of the dimensions of cavities of the heart
Time frame: 15 days
haemodynamic study of the conditions
Time frame: 15 days
characterization of ambient sound military aero by Sound Level Meter
Time frame: 15 days
sensitivity analysis of noise dosimetry
Time frame: 15 days
subjective perception of noise
Time frame: 15 days
analysis of clinical background for selection of sample subjects
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2010.
- Background: PubMed 18335099Jarup 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.
- Background: PubMed 7053913Andren 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.
- BackgroundISO 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
- BackgroundISO 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.
- BackgroundRosenstock, L. Criteria for a recommended standard: occupational noise exposure. National Institute for Occupational Safety and Health. NIOSH, publication June 1998. 98-126.
- Results publication: PubMed 16026021Tomei 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.
- Results publication: PubMed 9045028Tomei 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.
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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.
Fredesvinda M Méndez, MSc principal investigator
Universidad Politecnica de Madrid
Manuel Recuero, PhD study director
Universidad Politecnica de Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pericarditis, run by Universidad Politecnica de Madrid at 1 site in Spain.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 5 Feb 2010. 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 Spain. 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?
Results are not available in the source record.
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?
left ventricular systolic function (time frame: one 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 NCT01063582, which also lists 7 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 5 Feb 2010.