Trial document




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  DRKS00011725

Trial Description

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Title

Effects of exposition to simulated nocturnal railway noise on endothelial function in healthy adults

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The ZuG-trial investigates if exposition to nighttime railway noise effects the cardiovascular system in healthy adults. Therefore the endothelial function is studied.
The study is intended to elucidate whether the exposure to railway noise is associated with an increase in cardiovascular risk.

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Brief Summary in Scientific Language

The ZuG-trial investigates cardiovascular effects of railway noise patterns with different intensity during nighttime sleep.
During 3 study nights participants will be exposed to 2 noise patterns and 1 control pattern in a random and blinded fashion. During the nights polygraphic data is being collected. In the morning after each study night, endothelial and cardiac function are measured using ultrasound techniques. Through blood sampling different lab markers can be evaluated.

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Organizational Data

  •   DRKS00011725
  •   2017/02/27
  •   [---]*
  •   yes
  •   Approved
  •   837.265.16. (10584), Ethik-Kommission bei der Landesärztekammer Rheinland-Pfalz
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Secondary IDs

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Health Condition or Problem studied

  •   Hypertension ,coronary artery disease, myocardial infarction, sleep disorders, cardiac arrhythmia
  •   I10-I15 -  Hypertensive diseases
  •   I20-I25 -  Ischaemic heart diseases
  •   G47 -  Sleep disorders
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Interventions/Observational Groups

  •   Study night: Control pattern without noise events.
    During the night polygraphic data is being collected. In the morning after the study night, endothelial and cardiac function are measured using ultrasound techniques.
  •   Study night: During nighttime simulated railway noise with 30 noise events is played back.
    During the night polygraphic data is being collected. In the morning after the study night, endothelial and cardiac function are measured using ultrasound techniques.
  •   Study night: During nighttime simulated railway noise with 60 noise events is played back.
    During the night polygraphic data is being collected. In the morning after the study night, endothelial and cardiac function are measured using ultrasound techniques.
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Characteristics

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

Edothelial function messured as FMD % (via ultrasound) of arteria brachialis after study night

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Secondary Outcome

During study nights:
- blood pressure (PTT derived)
- Heart rate & heart rate variability and derived parameters
- Oxygen pulse and derived parameters
- actimetry
After study nights (in the morning)
- myocardial strain (Echokardiography) and derived parameters
- myocardial markers (hs Troponin)
-Stresshormons in blood
- Inflammation in blood (hs CRP, MCP-1, flow cytometrie in selected patients)
- coagulation activation (d-dimer, PAI-1, coagulation factors etc.)
-oxidative stress (MDA, TBARS, 3 nitrotyrosine)
- effect of p.o. vit C on endothelial function

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2017/05/01
  •   104
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   60   Years
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Additional Inclusion Criteria

- Physically and mentally healthy adults
- non-smokers
- no exposition to nocturnal railway noise at primary place of residence
-no nighttime noise exposure greater than Leq >45 dB, as determined by municipal noise maps.

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Exclusion Criteria

Any regular drug treatment within the last two months, except for oral contraceptives;
Place of residence with nocturnal road traffic noise Leq> 45 dB;
Pathologic Pittsburgh-Sleep quality-Index (PSQI) (>10) denoting sleep disorders;
Evidence of obstructive sleep apnea in screening questionnaire;
Average daily sleep duration < 6 hours;
Current shiftwork;
Sedative use;
Known epilepsy or other neurological or mental disorder for which sleep restriction is contraindicated;
pregnancy;
Hearing loss > 30 dB audiometry (age adjusted);
persons actively involved in anti-railway noise groups are excluded as are employees of railway companies or other companies with major financial interest in railway traffic

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Addresses

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    • Universitätsmedizin Mainz, Zentrum für Kardiologie, Kardiologie I
    • Langenbeckstr. 1
    • 55131  Mainz
    • Germany
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    • Universitätsmedizin Mainz, Zentrum für Kardiologie, Kardiologie I
    • Mr.  Johannes  Herzog 
    • Langenbeckstr. 1
    • 55131  Mainz
    • Germany
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    • Universitätsmedizin Mainz, Zentrum für Kardiologie, Kardiologie I
    • Ms.  Hannelore  Seiler 
    • Langenbeckstr. 1
    • 55131  Mainz
    • Germany
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Sources of Monetary or Material Support

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    • Stiftung Mainzer Herz
    • Niklas-Vogt-Straße 14
    • 55131  Mainz
    • Germany
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Status

  •   Recruiting complete, follow-up continuing
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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.