Trial document





This trial has been registered retrospectively.
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  DRKS00006050

Trial Description

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Title

Effect of nocturnal aircraft noise on vascular function in patients with cardiovascular disease o at increased risk thereof

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The study aims to evaluate the effects of simulated night time aircraft noise exposure on endothelial function of persons with cardiac risk and thereby elucidate the possible physiological mechanisms behind the associations between noise and myocardial infarction seen in epidemiological studies.

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Brief Summary in Scientific Language

randomised-blinded study comparing flow-mediated dilatation after noise exposure with control nights in a crossover design.

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Organizational Data

  •   DRKS00006050
  •   2014/04/04
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  •   yes
  •   Approved
  •   837.190.12(8291), Ethik-Kommission bei der Landesärztekammer Rheinland-Pfalz
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Secondary IDs

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Health Condition or Problem studied

  •   Coronary heart disease
  •   I25 -  Chronic ischaemic heart disease
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Interventions/Observational Groups

  •   Control nights without noise
  •   simulated nighttime aircraft noise with 60 events
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist, assessor
  •   Other
  •   Basic research/physiological study
  •   Crossover
  •   N/A
  •   N/A
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Primary Outcome

difference % absolute of flow-mediated-dilatation (FMD) on the morning after noise and control nights. The measurement is performed by determining the vessel diameter of the brachial artery with linear probe ultrasound before and after 5 minutes of proximal occlusion with a pressure cuff.


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Secondary Outcome

systolic blood pressure(continous),
sleep quality (VAS and Evening-Morning protocol of the German societey of sleep medicine DGSM)
Pulse transit time (Somnowatch during study nights)
adrenaline (concentration on the morning after study nights)
HRV (contiously Somnowatch)
HF (continously Somnowatch)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2013/03/20
  •   100
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   30   Years
  •   75   Years
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Additional Inclusion Criteria

Men and women between 30 and 75 years with established cardiovascular diseas or at a Framingham Risk > 10 % (Framingham Heart General CVD Risk , D'Agostino et. al), , who are not exposed to nighttime aircraft noise or other traffic noise exposure > 45 dB at their homes

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Exclusion Criteria

stroke
Nitrates in medication
medication changes in last 4 weeks
unstable cardiovascular disease (specified in study protocol)
hospitalization in the preceding 4 weeks
uncontrolled hypertension > 160/100 mmHg
severe cardiac valve stenosis or regurgitation
severely depresse LVEF < 30 %
renal insufficiency needing dialysis
exposure to traffic noise > Leq 45 dB at place of residence
sleep disorders (PSQI > 10)
positive Screening for obstructive sleep apnea (OSAS)
regular sleep duration < 6 hours
shift work
regular sedative use
Epilepsy or psychiatric disorders
shift workers
Pregnancy
hearing loss > 30 dB
employees of airports, airline and anti-noise activists

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Univesitätsmedizin Mainz
    • Mr.  Univ.-Prof. Dr. med.  Thomas  Münzel 
    • Langenbeckstr. 1
    • 55131  Mainz
    • Germany
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    • Universitätsmedizin Mainz
    • Mr.  Dr. med.  Frank  Schmidt 
    • Langenbeckstr. 1
    • 55131  Mainz
    • Germany
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    • Universitätsmedizin Mainz
    • Ms.  Hannelore  Seiler 
    • Langebeckstr. 1
    • 55131  Mainz
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsmedizin Mainz, II. Medizinische Klinik
    • Langenbeckstr. 1
    • 55131  Mainz
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.