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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00011725

Enrollment

104

Registered

2017-02-27

Start date

2017-05-01

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension ,coronary artery disease, myocardial infarction, sleep disorders, cardiac arrhythmia I10-I15 I20-I25 G47

Interventions

Group 1: 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 u

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

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.

Exclusion criteria

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 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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Germany

Contacts

Public ContactHannelore Seiler

Universitätsmedizin Mainz, Zentrum für Kardiologie, Kardiologie I

bahnlaerm@unimedizin-mainz.de06131 172476

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026