Sound ExposureNCT07556666
Effect of High-Level Headphone Sound Exposure on Exercise Responses in Young Healthy Individuals
An observational study of Sound Exposure and Exercise Performance, run by Saglik Bilimleri Universitesi.
Trial summary
This study will investigate the effect of high-level headphone sound exposure on cardiorespiratory responses and perceived exertion during a submaximal treadmill exercise test in young healthy individuals. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Sound Exposure, Exercise Performance
- What is being tested?
- High-Level Headphone Sound Exposure and No-Sound Headphone Condition
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2026to 1 May 2027
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy young adults aged 18 to 30 years without known disease and without a regular exercise habit.
Who may be able to join
- Healthy adults aged 18 to 30 years
- Male or female participants
- No regular exercise habit
- Voluntary participation with written informed consent
Who cannot join
- Any cardiopulmonary, neurological, or musculoskeletal disease
- Any acute cardiovascular, respiratory, or musculoskeletal complaint
- Infection, fever, dizziness, fatigue, or similar temporary health problem on the test day
- Alcohol consumption within 12 hours before testing
- Caffeine consumption within 3 hours before testing
- Vigorous physical activity within 24 hours before testing
- Inability to complete the exercise protocol or withdrawal from the study
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effect of High-Level Headphone Sound Exposure on Cardiorespiratory Responses and Perceived Exertion
This study will investigate the effect of high-level headphone sound exposure on cardiorespiratory responses and perceived exertion during a submaximal treadmill exercise test in young healthy individuals. Healthy volunteers aged 18 to 30 years will complete two exercise sessions under two different conditions: zero-sound and high-level sound exposure. Heart rate, oxygen saturation, blood pressure, and perceived exertion will be evaluated before, during, and after exercise.
Read the detailed description
Portable audio devices and headphones are widely used in daily life, especially by young individuals. High-level sound exposure may affect not only the auditory system but also cardiovascular and respiratory responses. During exercise, auditory stimuli may also influence perceived exertion.
The aim of this study is to examine the effect of high-level headphone sound exposure on cardiorespiratory responses and perceived exertion during submaximal treadmill exercise in young healthy individuals. The study will be conducted in the laboratory of the Department of Physiotherapy and Rehabilitation, Hamidiye Faculty of Health Sciences, University of Health Sciences. A total of 38 healthy volunteers aged 18 to 30 years will be included. Each participant will complete both study conditions in random order. In the zero-sound condition, participants will wear headphones without music playback. In the high-level sound condition, participants will listen to the same music file at approximately 80-82 dB using the same headphone model and playback device.
Exercise testing will be performed according to the Ebbeling Single-Stage Submaximal Treadmill Walking Test. The two sessions will be performed on the same day with a 30-minute washout period between conditions. Outcome measures will include heart rate, oxygen saturation, blood pressure, and perceived exertion assessed with the Modified Borg Scale.
- Conditions
- Sound Exposure, Exercise Performance
- Being tested
- High-Level Headphone Sound Exposure, No-Sound Headphone Condition
- Keywords
- Noise, Exercise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Level Headphone Sound ExposureBehavioural
Participants will listen to music at a predefined high sound level via headphones during the submaximal treadmill walking test. Sound intensity will be controlled using a decibel meter to ensure consistency across participants.(approximately 80 dB LAeq).
No-Sound Headphone ConditionBehavioural
Participants will wear headphones without any sound during the submaximal treadmill walking test. This condition serves as the control for comparison with the high sound exposure condition.
| Study group | Role | What they receive |
|---|---|---|
| High-Level Headphone Sound Group | Participants perform the submaximal treadmill exercise test under high-level headphone sound exposure (approximately 80 dB LAeq). Cardiopulmonary responses and perceived exertion are assessed during exercise. Receives: Behavioral: High-Level Headphone Sound Exposure | |
| No-Sound Control Group | Participants perform the same submaximal treadmill exercise test under a no-sound headphone condition serving as the control. Cardiopulmonary responses and perceived exertion are assessed during exercise. Receives: Behavioral: No-Sound Headphone Condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived Exertion
Perceived exertion will be assessed using the Modified Borg Scale (Borg Category Ratio Scale, CR10) under zero-sound and high-level sound conditions during submaximal treadmill exercise. The scale ranges from 0 to 10, where higher scores indicate greater perceived exertion.
Measured: Baseline (pre-exercise), at the end of each exercise stage, and immediately post-exercise
Heart Rate
Heart rate recorded under zero-sound and high-level sound conditions during submaximal treadmill exercise.
Measured: Baseline (pre-exercise), at the end of each exercise stage, and immediately post-exercise
Secondary outcomes (2)
Oxygen Saturation
Oxygen saturation recorded under zero-sound and high-level sound conditions during submaximal treadmill exercise.
Measured: Baseline (pre-exercise), at the end of each exercise stage, and immediately post-exercise
Blood Pressure
Systolic and diastolic blood pressure measured under zero-sound and high-level sound conditions.
Measured: Baseline (pre-exercise), at the end of each exercise stage, and immediately post-exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study start1 May 2026 (estimated)
- Primary completion1 May 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sound ExposureStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ESRA PEHLIVAN, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07556666
- Sponsor's protocol ID
- Noise&Exercise1
- Status last verified
- Apr 2026
- First submitted
- 13 Apr 2026
- Last updated
- 29 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of High-Level Headphone Sound Exposure on Cardiorespiratory Responses and Perceived Exertion
- ClinicalTrials.gov ID
- NCT07556666
- Acronym / sponsor ID
- Noise&Exercise1
- Conditions
- Sound Exposure, Exercise Performance
- Keywords
- Noise, Exercise
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 29 Apr 2026 (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.
This study will investigate the effect of high-level headphone sound exposure on cardiorespiratory responses and perceived exertion during a submaximal treadmill exercise test in young healthy individuals. Healthy volunteers aged 18 to 30 years will complete two exercise sessions under two different conditions: zero-sound and high-level sound exposure. Heart rate, oxygen saturation, blood pressure, and perceived exertion will be evaluated before, during, and after exercise.
Detailed description
Portable audio devices and headphones are widely used in daily life, especially by young individuals. High-level sound exposure may affect not only the auditory system but also cardiovascular and respiratory responses. During exercise, auditory stimuli may also influence perceived exertion.
The aim of this study is to examine the effect of high-level headphone sound exposure on cardiorespiratory responses and perceived exertion during submaximal treadmill exercise in young healthy individuals. The study will be conducted in the laboratory of the Department of Physiotherapy and Rehabilitation, Hamidiye Faculty of Health Sciences, University of Health Sciences. A total of 38 healthy volunteers aged 18 to 30 years will be included. Each participant will complete both study conditions in random order. In the zero-sound condition, participants will wear headphones without music playback. In the high-level sound condition, participants will listen to the same music file at approximately 80-82 dB using the same headphone model and playback device.
Exercise testing will be performed according to the Ebbeling Single-Stage Submaximal Treadmill Walking Test. The two sessions will be performed on the same day with a 30-minute washout period between conditions. Outcome measures will include heart rate, oxygen saturation, blood pressure, and perceived exertion assessed with the Modified Borg Scale.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-Level Headphone Sound Group | – | Behavioral: High-Level Headphone Sound ExposureParticipants perform the submaximal treadmill exercise test under high-level headphone sound exposure (approximately 80 dB LAeq). Cardiopulmonary responses and perceived exertion are assessed during exercise. |
| No-Sound Control Group | – | Behavioral: No-Sound Headphone ConditionParticipants perform the same submaximal treadmill exercise test under a no-sound headphone condition serving as the control. Cardiopulmonary responses and perceived exertion are assessed during exercise. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy young adults aged 18 to 30 years without known disease and without a regular exercise habit.
Key inclusion criteria (4 listed)
- Healthy adults aged 18 to 30 years
- Male or female participants
- No regular exercise habit
- Voluntary participation with written informed consent
Key exclusion criteria (7 listed)
- Any cardiopulmonary, neurological, or musculoskeletal disease
- Any acute cardiovascular, respiratory, or musculoskeletal complaint
- Infection, fever, dizziness, fatigue, or similar temporary health problem on the test day
- Alcohol consumption within 12 hours before testing
- Caffeine consumption within 3 hours before testing
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 |
|---|---|---|
| High-Level Headphone Sound ExposureParticipants will listen to music at a predefined high sound level via headphones during the submaximal treadmill walking test. Sound intensity will be controlled using a decibel meter to ensure consistency across participants.(approximately 80 dB LAeq). | Behavioural | High-Level Headphone Sound Group |
| No-Sound Headphone ConditionParticipants will wear headphones without any sound during the submaximal treadmill walking test. This condition serves as the control for comparison with the high sound exposure condition. | Behavioural | No-Sound Control Group |
Primary outcome
Perceived Exertion
Time frame: Baseline (pre-exercise), at the end of each exercise stage, and immediately post-exercise
Perceived exertion will be assessed using the Modified Borg Scale (Borg Category Ratio Scale, CR10) under zero-sound and high-level sound conditions during submaximal treadmill exercise. The scale ranges from 0 to 10, where higher scores indicate greater perceived exertion.
Heart Rate
Time frame: Baseline (pre-exercise), at the end of each exercise stage, and immediately post-exercise
Heart rate recorded under zero-sound and high-level sound conditions during submaximal treadmill exercise.
2 secondary outcomes
Oxygen Saturation
Time frame: Baseline (pre-exercise), at the end of each exercise stage, and immediately post-exercise
Blood Pressure
Time frame: Baseline (pre-exercise), at the end of each exercise stage, and immediately post-exercise
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 29 Apr 2026.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Sound Exposure and Exercise Performance, run by Saglik Bilimleri Universitesi.
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 4 inclusion and 7 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 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Esra Pehlivan (02167778777, esra.pehlivan@sbu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived Exertion (time frame: Baseline (pre-exercise), at the end of each exercise stage, and immediately post-exercise). 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?
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 29 Apr 2026.