Differential effects of aircraft noise patterns with comparable averaged sound pressure levels on endothelial function in persons at increased cardiovascular risk
- Conditions
- Hypertensionmyocardial infarctionsleep disorderscardiac arrhythmia
- Registration Number
- DRKS00010670
- Lead Sponsor
- niversitätsmedizin Mainz, Zentrum für Kardiologie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 105
• Men and women with ages ranging from 30 to 75 years with established cardiovascular disease or persons at an increased 10 year risk above 10 % as determined by the Fram-ingham Heart General CVD Risk (D'Agostino et. al), who are not exposed to relevant nocturnal aircraft noise exposure at their primary place of residence. Also they do not have any nighttime noise exposure greater than Leq >45 dB, as determined by municipal noise maps
• Vascular abnormalities or conditions that preclude FMD measurement on arm (dialysis shunt, lypmphedema etc.)
• History of stroke
• Patients taking long acting nitrated
• Any medication changes within the preceding 4 weeks
• Hearing loss > 30 dB audiometry (age adjusted)
• Unstable cardiovascular disease (myocardial infarction in the last 3 months, hospitalization within the last 4 weeks, uncontrolled hypertension, history of hypertensive emergency, uncontrolled supraventricular tachycardia (> 120 bpm in case of AF), history of sustained VT, history of sudden cardiac death, severe valvular stenosis or regurgitation, severely reduced left ventricular ejection fraction)
• Place of residence with nocturnal road traffic noise Leq> 45 dB (municipal noise map city of Mainz)
• Place of residence with maximum nocturnal aircraft noise Leq3 > 45 dB continuous sound pressure level independent of flight direction (on the basis of data from state of Hessia; www.laermkarten.de)
• Pathologic PSQI (>10) denoting sleep disorders
• Evidence of obstructive sleep apnea in screening questionnaire
• Average daily sleep duration below 6 hours.
• Current shift work
• Sedative use (>= 1 dose/ week)
• Known epilepsy or other neurological or mental disorder for which sleep restriction is contraindicated.
• pregnancy
• persons actively involved in anti-aircraft groups are excluded as are employees of air-ports, airlines or other companies with major financial interest in air traffic.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method endothelial function measured as FMD % (by ultrasonography) of the brachial artery the morning after each 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 markerss (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