Noise; Adverse EffectNOXYCARDNCT06294340
Noise, Oxidative Stress and Cardiovascular System
An observational study of Noise; Adverse Effect and Noise Exposure, run by University of Belgrade at 1 site in Serbia.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Noise; Adverse Effect, Noise Exposure
- What is being tested?
- Exposure to loud pre-recorded road traffic noise
- How many people
- 150 participants
- Where
- 1 siteSerbia
- Study dates
- Jan 2025to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- age 18-65
- both genders
- good self-reported health
Who cannot join
- diabetes mellitus
- arterial hypertension or other cardiovascular diseases
- kidney diseases
- pregnancy
- malignant diseases
- mental diseases
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Serbia1 site
Faculty of Medicine, University of Belgrade
Belgrade, Beograd, 11040
About this study
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
- Being tested
- Exposure to loud pre-recorded road traffic noise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure to loud pre-recorded road traffic noiseOther
Participants of both arms will be exposed to the same loud pre-recorded road traffic noise in a laboratory setting.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Exposure to loud pre-recorded road traffic noise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic blood pressure
Systolic blood pressure in mmHg, higher values indicate high risk
Measured: 10, 40, and 50 minutes
Concentration of stress hormone
Cortisol level in mcg/dL, higher values indicate high risk
Measured: 10, 40, and 50 minutes
Secondary outcomes (2)
Diastolic blood pressure
Diastolic blood pressure in mmHg, higher values indicate high risk
Measured: 10, 40, and 50 minutes
Concentration of inflammation parameters
Interleukin-1-Beta levels in pg/mL, higher values indicate high risk
Measured: 10, 40, and 50 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2024
- Study startJan 2025 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Noise; Adverse EffectStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Belgrade
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katarina Paunovic, University of Belgrade
- Investigators
- Katarina Paunovic, MD, PhD, Principal investigator, University of Belgrade
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06294340
- Sponsor's protocol ID
- 1322-IX/42
- Acronym
- NOXYCARD
- Status last verified
- Feb 2024
- First submitted
- 19 Feb 2024
- Last updated
- 5 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data will be shared. Data will be shared in cumulative form.
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.
PubMed 29459307Paunovic 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.
PubMed 24529003
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noise, Oxidative Stress and Cardiovascular System
- ClinicalTrials.gov ID
- NCT06294340
- Acronym / sponsor ID
- NOXYCARD / 1322-IX/42
- Conditions
- Noise; Adverse Effect, Noise Exposure
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of BelgradeUniversity, hospital or other
- Study start
- Jan 2025 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 5 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants with normal body weight | – | Other: Exposure to loud pre-recorded road traffic noiseThe 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. |
| Overweight / obese participants | – | Other: Exposure to loud pre-recorded road traffic noiseThe 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- age 18-65
- both genders
- good self-reported health
Key exclusion criteria (6 listed)
- diabetes mellitus
- arterial hypertension or other cardiovascular diseases
- kidney diseases
- pregnancy
- malignant diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exposure to loud pre-recorded road traffic noiseParticipants of both arms will be exposed to the same loud pre-recorded road traffic noise in a laboratory setting. | Other | Overweight / obese participants, Participants with normal body weight |
Primary outcome
Systolic blood pressure
Time frame: 10, 40, and 50 minutes
Systolic blood pressure in mmHg, higher values indicate high risk
Concentration of stress hormone
Time frame: 10, 40, and 50 minutes
Cortisol level in mcg/dL, higher values indicate high risk
2 secondary outcomes
Diastolic blood pressure
Time frame: 10, 40, and 50 minutes
Concentration of inflammation parameters
Time frame: 10, 40, and 50 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
- Results publication: PubMed 29459307Paunovic 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.
- Results publication: PubMed 24529003Paunovic 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.
- Individual participant dataSharing planned: No. No individual participant data will be shared. Data will be shared in cumulative form.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Katarina Paunovic, MD, PhD principal investigator
University of Belgrade
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Noise; Adverse Effect and Noise Exposure, run by University of Belgrade at 1 site in Serbia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Serbia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Branko Jakovljevic, MD, PhD (+381113612762, jakovljevic@dr.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic blood pressure (time frame: 10, 40, and 50 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06294340, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2024.