Noise, Oxidative Stress and Cardiovascular System

Not yet recruiting

• Conditions: Noise; Adverse Effect; Noise Exposure
• Interventions: Other: Exposure to loud pre-recorded road traffic noise

• Registration Number: NCT06294340
• Lead Sponsor: University of Belgrade

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-02
• Study First Submitted: 2024-02-19
• Study First Submitted QC: 2024-02-27
• Last Update Submitted: 2024-02-27
• Study First Posted: 2024-03-05
• Last Update Posted: 2024-03-05
• Study Start: 2025-01
• Primary Completion: 2027-12
• Study Completion: 2028-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Overweight / obese participants	Exposure to loud pre-recorded road traffic noise	The effects of noise exposure on blood pressure, cardiovascular and hemodynamic parameters, stress hormones, and markers of oxidative stress and inflammation in individuals with overweight/obesity.
Participants with normal body weight	Exposure to loud pre-recorded road traffic noise	The effects of noise exposure on blood pressure, cardiovascular and hemodynamic parameters, stress hormones, and markers of oxidative stress and inflammation in individuals with normal body weight.

Primary Outcome Measures

Name	Time	Method
Systolic blood pressure	10, 40, and 50 minutes	Systolic blood pressure in mmHg, higher values indicate high risk
Concentration of stress hormone	10, 40, and 50 minutes	Cortisol level in mcg/dL, higher values indicate high risk

Secondary Outcome Measures

Name	Time	Method
Concentration of inflammation parameters	10, 40, and 50 minutes	Interleukin-1-Beta levels in pg/mL, higher values indicate high risk
Diastolic blood pressure	10, 40, and 50 minutes	Diastolic blood pressure in mmHg, higher values indicate high risk

Trial Locations

Locations (1)

Faculty of Medicine, University of Belgrade; 🇷🇸 Belgrade, Beograd, Serbia