Effect of nocturnal aircraft noise on vascular function in patients with cardiovascular disease o at increased risk thereof

Not Applicable

Recruiting

Conditions: Coronary heart disease
I25
Chronic ischaemic heart disease

Registration Number: DRKS00006050

Lead Sponsor: nivesitätsmedizin Mainz

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 100

Inclusion Criteria

Men and women between 30 and 75 years with established cardiovascular diseas or at a Framingham Risk > 10 % (Framingham Heart General CVD Risk , D'Agostino et. al), , who are not exposed to nighttime aircraft noise or other traffic noise exposure > 45 dB at their homes

Exclusion Criteria

stroke
Nitrates in medication
medication changes in last 4 weeks
unstable cardiovascular disease (specified in study protocol)
hospitalization in the preceding 4 weeks
uncontrolled hypertension > 160/100 mmHg
severe cardiac valve stenosis or regurgitation
severely depresse LVEF < 30 %
renal insufficiency needing dialysis
exposure to traffic noise > Leq 45 dB at place of residence
sleep disorders (PSQI > 10)
positive Screening for obstructive sleep apnea (OSAS)
regular sleep duration < 6 hours
shift work
regular sedative use
Epilepsy or psychiatric disorders
shift workers
Pregnancy
hearing loss > 30 dB
employees of airports, airline and anti-noise activists

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
difference % absolute of flow-mediated-dilatation (FMD) on the morning after noise and control nights. The measurement is performed by determining the vessel diameter of the brachial artery with linear probe ultrasound before and after 5 minutes of proximal occlusion with a pressure cuff. <br><br><br>

Secondary Outcome Measures

Name	Time	Method
systolic blood pressure(continous), <br>sleep quality (VAS and Evening-Morning protocol of the German societey of sleep medicine DGSM)<br>Pulse transit time (Somnowatch during study nights)<br>adrenaline (concentration on the morning after study nights)<br>HRV (contiously Somnowatch)<br>HF (continously Somnowatch)