Noise, Oxidative Stress and Cardiovascular System

NCT06294340 | Not Yet Recruiting

• 1 other identifier: 1322-IX/42
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Noise; Adverse Effect; Noise Exposure

Outcome Measures

Primary Outcomes (2)

• Systolic blood pressure

  Systolic blood pressure in mmHg, higher values indicate high risk

  10, 40, and 50 minutes

• Concentration of stress hormone

  Cortisol level in mcg/dL, higher values indicate high risk

  10, 40, and 50 minutes

Secondary Outcomes (2)

• Diastolic blood pressure

  10, 40, and 50 minutes

• Concentration of inflammation parameters

  10, 40, and 50 minutes

Study Arms (2)

Participants with normal body weight

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.

Other: Exposure to loud pre-recorded road traffic noise

Overweight / obese participants

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.

Other: Exposure to loud pre-recorded road traffic noise

Interventions

Exposure to loud pre-recorded road traffic noise OTHER

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

Overweight / obese participants; Participants with normal body weight

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All persons who visit the Nutrition Counselling Unit of the Institute of Hygiene and Medical Ecology, located at the Faculty of Medicine, University of Belgrade will be eligible to participate in the study. The study population will include 75 participants with normal weight and 75 overweight/obese participants who meet the inclusion criteria for the survey. Participants will be informed of the protocol and sign an informed consent form.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Belgrade: lead

Study Sites (1)

Faculty of Medicine, University of Belgrade

Belgrade, Beograd, 11040, Serbia

Location

Related 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.

  PMID: 29459307 RESULT

• 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 25.

  PMID: 24529003 RESULT

Study Officials

• Katarina Paunovic, MD, PhD

  University of Belgrade

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Branko Jakovljevic, MD, PhD

CONTACT

+381113612762; jakovljevic@dr.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 19, 2024
• First Posted: March 5, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: March 5, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)