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NCT Number: NCT06294340

Noise, Oxidative Stress and Cardiovascular System

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.

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Key information

Conditions

Noise; Adverse Effect Noise Exposure

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Faculty of Medicine, University of Belgrade

Belgrade, Beograd, 11040, Serbia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Systolic blood pressure

    Time frame: 10, 40, and 50 minutes

    Systolic blood pressure in mmHg, higher values indicate high risk

  2. Concentration of stress hormone

    Time frame: 10, 40, and 50 minutes

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

Secondary outcomes

  1. Diastolic blood pressure

    Time frame: 10, 40, and 50 minutes

    Diastolic blood pressure in mmHg, higher values indicate high risk

  2. Concentration of inflammation parameters

    Time frame: 10, 40, and 50 minutes

    Interleukin-1-Beta levels in pg/mL, higher values indicate high risk

Study contacts

Contact information is provided by the study sponsor or research team.

Branko Jakovljevic, MD, PhD

CONTACT

[email protected]

+381113612762

Sponsors and collaborators

Lead sponsor

University of Belgrade

Other

Registry information

Acronym: NOXYCARD

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Mar 5, 2024
Registry last updated
Mar 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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