Hypertension myocardial infarction sleep disorders cardiac arrhythmia
Conditions
Interventions
Group 1: Study night Control without noise
Group 2: study night with 60 simulated noise events with Lmax ca. 60 dB(A)
Group 3: study night with 120 simulated noise events with Lmax ca. 57 dB(A)
Sponsors
Universitätsmedizin Mainz, Zentrum für Kardiologie
Eligibility
Sex/Gender
All
Age
30 Years to 75 Years
Inclusion criteria
Inclusion criteria: • 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
Exclusion criteria
Exclusion criteria: • 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| endothelial function measured as FMD % (by ultrasonography) of the brachial artery the morning after each 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 markerss (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
Outcome results
None listed