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

Not Applicable

• Conditions: Hypertension ,coronary artery disease, myocardial infarction, sleep disorders, cardiac arrhythmia; I10-I15; I20-I25; G47; Hypertensive diseases; Ischaemic heart diseases; Sleep disorders

• Registration Number: DRKS00011725
• Lead Sponsor: niversitätsmedizin Mainz, Zentrum für Kardiologie, Kardiologie I

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-02-27
• Study Completion: 2018-07-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 74

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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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