Noise, Oxidative Stress and Cardiovascular System

Noise Exposure Clinical Trial

— NOXYCARD  

Official title:

Noise, Oxidative Stress and Cardiovascular System

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06294340
• Other study ID #: 1322-IX/42
• Status: Not yet recruiting
• Start date: January 2025
• Est. completion date: December 2028

Study information

• Verified date: February 2024
• Source: University of Belgrade
• Contact: Branko Jakovljevic, MD, PhD
• Phone: +381113612762
• Email: jakovljevic[@]dr.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Environmental noise represents a health problem for at least one in five citizens of the European Union. Noise exposure leads to the development of arterial hypertension, myocardial infarction, stroke, and obesity. Given the limited information on noise exposure and noise effects on humans in the Republic of Serbia, the overall objective of NOXYCARD is to collect environmental noise levels data; to identify long-term and short-term noise effects on the cardiovascular system; and to evaluate the levels of blood stress hormones, oxidative stress, and inflammation in individuals with normal body weight and individuals with obesity.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: December 2028
• Est. primary completion date: December 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• age 18-65
• both genders
• good self-reported health

Exclusion Criteria:

• diabetes mellitus
• arterial hypertension or other cardiovascular diseases
• kidney diseases
• pregnancy
• malignant diseases
• mental diseases

Related Conditions & MeSH terms

• Noise Exposure
• Noise; Adverse Effect

Intervention

Other:
• Exposure to loud pre-recorded road traffic noise
Participants of both arms will be exposed to the same loud pre-recorded road traffic noise in a laboratory setting.

Locations

Country	Name	City	State
Serbia	Faculty of Medicine, University of Belgrade	Belgrade	Beograd

Sponsors (1)

Lead Sponsor	Collaborator
University of Belgrade

Country where clinical trial is conducted

Serbia, 

References & Publications (2)

Paunovic K, Jakovljevic B, Stojanov V. The timeline of blood pressure changes and hemodynamic responses during an experimental noise exposure. Environ Res. 2018 May;163:249-262. doi: 10.1016/j.envres.2018.01.048. Epub 2018 Feb 22. — View Citation

Paunovic K, Stojanov V, Jakovljevic B, Belojevic G. Thoracic bioelectrical impedance assessment of the hemodynamic reactions to recorded road-traffic noise in young adults. Environ Res. 2014 Feb;129:52-8. doi: 10.1016/j.envres.2014.01.001. Epub 2014 Jan 2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Systolic blood pressure	Systolic blood pressure in mmHg, higher values indicate high risk	10, 40, and 50 minutes
Primary	Concentration of stress hormone	Cortisol level in mcg/dL, higher values indicate high risk	10, 40, and 50 minutes
Secondary	Diastolic blood pressure	Diastolic blood pressure in mmHg, higher values indicate high risk	10, 40, and 50 minutes
Secondary	Concentration of inflammation parameters	Interleukin-1-Beta levels in pg/mL, higher values indicate high risk	10, 40, and 50 minutes