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Not yet recruiting NCT06294340

Noise, Oxidative Stress and Cardiovascular System

Observational Noise; Adverse Effect Noise Exposure

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Exposure to loud pre-recorded road traffic noise.
Who it may be relevant to
Registry conditions: Noise; Adverse Effect, Noise Exposure. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Serbia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Systolic blood pressure [Time frame: 10, 40, and 50 minutes]
  • Concentration of stress hormone [Time frame: 10, 40, and 50 minutes]
Secondary outcome measures (2)
  • Diastolic blood pressure [Time frame: 10, 40, and 50 minutes]
  • Concentration of inflammation parameters [Time frame: 10, 40, and 50 minutes]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

Serbia · 1 center
  • Faculty of Medicine, University of Belgrade — Belgrade

Publications

  • 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
  • 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

Identifiers

NCT: NCT06294340 · 1322-IX/42

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗