- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07556666
Effect of High-Level Headphone Sound Exposure on Exercise Responses in Young Healthy Individuals
The Effect of High-Level Headphone Sound Exposure on Cardiorespiratory Responses and Perceived Exertion
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Esra Pehlivan
- Phone Number: 02167778777
- Email: esra.pehlivan@sbu.edu.tr
Study Contact Backup
- Name: Duygu Doğanay
- Phone Number: 2867 02167778777
- Email: duygudoganay.mail@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Healthy adults aged 18 to 30 years
- Male or female participants
- No regular exercise habit
- Voluntary participation with written informed consent
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
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 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline (pre-exercise), at the end of each exercise stage, and immediately post-exercise
|
|
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.
|
Baseline (pre-exercise), at the end of each exercise stage, and immediately post-exercise
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Oxygen Saturation
Time Frame: Baseline (pre-exercise), at the end of each exercise stage, and immediately post-exercise
|
Oxygen saturation recorded under zero-sound and high-level sound conditions during submaximal treadmill exercise.
|
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
|
Systolic and diastolic blood pressure measured under zero-sound and high-level sound conditions.
|
Baseline (pre-exercise), at the end of each exercise stage, and immediately post-exercise
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Noise&Exercise1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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