- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07932964
Listening Volume Adjustment in Bone and Air Conduction Headphones
Behavioral Comparison of Self-Adjusted Listening Volume in Bone Conduction Versus Air Conduction Headphones in Noise
Open-ear bone conduction headphones are increasingly used as an alternative to conventional in-ear air conduction headphones. Because bone conduction headphones do not block the ear canal, it is often assumed that users may be more affected by background noise and may increase their listening volume to hear music clearly. However, direct evidence supporting this assumption is limited.
This study aims to compare self-adjusted listening volumes between bone conduction and air conduction headphones under different background noise conditions. Approximately 32 healthy adults aged 18-35 years with normal hearing will participate in the study. Each participant will test three listening conditions: in-ear air conduction headphones, open-ear bone conduction headphones, and bone conduction headphones combined with ear occlusion. Each condition will be tested in a quiet environment and under four levels of background noise (30, 40, 50, and 60 dB(A)).
Participants will listen to the same music and adjust the volume themselves to a level they consider comfortable and clear for prolonged listening. The selected listening volume and adjustment behavior will be recorded and compared across headphone types and noise conditions.
The findings may provide behavioral evidence on whether open-ear bone conduction headphone users choose higher listening volumes in noisy environments compared with users of conventional in-ear air conduction headphones, helping to improve understanding of potential noise exposure and hearing safety.
Aperçu de l'étude
Statut
Les conditions
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Xiao Liu, M.D.
- Numéro de téléphone: +86 19550170533
- E-mail: 11618337@zju.edu.cn
Lieux d'étude
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Zhejiang
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Hangzhou, Zhejiang, Chine, 310000
- Recrutement
- The Second Affiliated Hospital, Zhejiang University, School of Medicine
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Contact:
- Xiao Liu
- Numéro de téléphone: +86 195 5017 0533
- E-mail: 11618337@zju.edu.cn
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Age 18-35 years.
- Type A, As, or Ad tympanogram in both ears.
- Normal hearing in both ears, defined as pure-tone hearing thresholds of ≤20 dB HL at each of the following frequencies: 0.25, 0.5, 1, 2, 4, and 8 kHz.
- Willingness to participate and ability to understand and provide written informed consent.
Exclusion Criteria:
- History of prolonged exposure to high-intensity noise.
- History of prolonged use of ototoxic medications.
- History of otologic diseases resulting in permanent changes in hearing thresholds.
- Previous diagnosis of hereditary hearing loss or a definite family history of 5. hearing loss.
- History of migraine or other neurological disorders that may affect sound tolerance, auditory perception, or study performance.
- History of epilepsy, sound-induced seizures, or unexplained episodes of loss of consciousness or convulsions.
- Current bothersome tinnitus or symptoms of hyperacusis.
- Any other condition that may make participation in the study inappropriate, including psychiatric disorders, cognitive impairment, substance or alcohol dependence, inability to comply with study procedures, or other medical or social factors considered relevant by the investigator.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Science basique
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: AC-BC
Participants will first use in-ear air conduction headphones (AC), followed by open-ear bone conduction headphones (BC), and then bone conduction headphones combined with ear occlusion (BC+Occlusion). Each listening condition will be tested in a quiet environment and under background noise levels of 30, 40, 50, and 60 dB(A). Participants will independently adjust the music volume to a level they consider comfortable and clear. |
Participants will wear in-ear air conduction headphones and independently adjust the music volume to a level they consider comfortable and clear for prolonged listening. Testing will be conducted in a quiet environment and under background noise levels of 30, 40, 50, and 60 dB(A). The final selected volume and adjustment behavior will be recorded. Participants will wear open-ear bone conduction headphones and independently adjust the music volume to a level they consider comfortable and clear for prolonged listening. Testing will be conducted in a quiet environment and under background noise levels of 30, 40, 50, and 60 dB(A). The final selected volume and adjustment behavior will be recorded. Participants will wear open-ear bone conduction headphones while simultaneously inserting in-ear air conduction headphones into both ear canals to create an ear occlusion condition. Music will be delivered exclusively through the bone conduction headphones. Participants will independently adjust the music volume to a level they consider comfortable and clear for prolonged listening. Testing will be conducted in a quiet environment and under background noise levels of 30, 40, 50, and 60 dB(A). The final selected volume and adjustment behavior will be recorded. |
|
Expérimental: BC-AC
Participants will first use open-ear bone conduction headphones (BC), followed by in-ear air conduction headphones (AC), and then bone conduction headphones combined with ear occlusion (BC+Occlusion). Each listening condition will be tested in a quiet environment and under background noise levels of 30, 40, 50, and 60 dB(A). Participants will independently adjust the music volume to a level they consider comfortable and clear. |
Participants will wear in-ear air conduction headphones and independently adjust the music volume to a level they consider comfortable and clear for prolonged listening. Testing will be conducted in a quiet environment and under background noise levels of 30, 40, 50, and 60 dB(A). The final selected volume and adjustment behavior will be recorded. Participants will wear open-ear bone conduction headphones and independently adjust the music volume to a level they consider comfortable and clear for prolonged listening. Testing will be conducted in a quiet environment and under background noise levels of 30, 40, 50, and 60 dB(A). The final selected volume and adjustment behavior will be recorded. Participants will wear open-ear bone conduction headphones while simultaneously inserting in-ear air conduction headphones into both ear canals to create an ear occlusion condition. Music will be delivered exclusively through the bone conduction headphones. Participants will independently adjust the music volume to a level they consider comfortable and clear for prolonged listening. Testing will be conducted in a quiet environment and under background noise levels of 30, 40, 50, and 60 dB(A). The final selected volume and adjustment behavior will be recorded. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Self-Adjusted Listening Volume From Quiet to 60 dB(A) Background Noise Levels
Délai: During the study visit (approximately 1-2 hours).
|
The change in final self-adjusted music volume from the quiet condition to the 60 dB(A) background noise condition will be calculated separately for each headphone condition (in-ear air conduction headphones [AC] and open-ear bone conduction headphones [BC]). The change will be calculated as the final volume at 60 dB(A) minus the final volume in the quiet condition. The differences in volume change among the two headphone conditions will be compared. |
During the study visit (approximately 1-2 hours).
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Self-Adjusted Listening Volume From Quiet to 30, 40, and 50 dB(A) Background Noise Levels
Délai: During the study visit (approximately 1-2 hours).
|
The change in final self-adjusted music volume from the quiet condition to each background noise level (30, 40, and 50 dB(A)) will be calculated separately for in-ear air conduction headphones (AC) and open-ear bone conduction headphones (BC). The change will be calculated as the final volume at each noise level minus the final volume in the quiet condition. The volume changes between the two headphone conditions will be compared at each noise level. |
During the study visit (approximately 1-2 hours).
|
|
Final Self-Adjusted Listening Volume at Different Background Noise Levels
Délai: During the study visit (approximately 1-2 hours).
|
The final self-adjusted music volume at quiet condition, 30, 40, 50, and 60 dB(A) background noise levels will be recorded and compared between AC and BC headphones. |
During the study visit (approximately 1-2 hours).
|
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Number of Volume Adjustments
Délai: During the study visit (approximately 1-2 hours).
|
The total number of individual volume adjustments made by each participant during each test will be recorded and compared between AC and BC headphones under different background noise conditions. |
During the study visit (approximately 1-2 hours).
|
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Total Time Required for Volume Adjustment
Délai: During the study visit (approximately 1-2 hours).
|
The total time from the beginning of volume adjustment to reaching the final self-adjusted listening volume will be recorded and compared between AC and BC headphones under different background noise conditions. |
During the study visit (approximately 1-2 hours).
|
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Cumulative Magnitude of Volume Adjustments
Délai: During the study visit (approximately 1-2 hours).
|
The cumulative magnitude of volume adjustments during each test will be calculated as the sum of the absolute values of all individual volume changes, regardless of the direction of adjustment, and compared between AC and BC headphones under different background noise conditions. |
During the study visit (approximately 1-2 hours).
|
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Subjective Perception of Vibration During Bone Conduction Headphone Use
Délai: During the study visit (approximately 1-2 hours).
|
Participants will be asked whether they perceive vibration while using bone conduction headphones at their final selected listening volume. The presence or absence of perceived vibration will be recorded under different background noise conditions. |
During the study visit (approximately 1-2 hours).
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Self-Adjusted Listening Volume With Ear Occlusion During Bone Conduction Listening
Délai: During the study visit (approximately 1-2 hours).
|
The change in final self-adjusted music volume from the quiet condition to each background noise condition (30, 40, 50, and 60 dB(A)) will be calculated when participants use bone conduction headphones with bilateral ear occlusion (BC+Occlusion). The results will be compared with those obtained using bone conduction headphones without ear occlusion (BC) to evaluate the effect of ear occlusion on noise-induced volume adjustment. |
During the study visit (approximately 1-2 hours).
|
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Final Self-Adjusted Listening Volume With Ear Occlusion During Bone Conduction Listening
Délai: Time Frame: During the study visit (approximately 1-2 hours).
|
The final self-adjusted music volume under quiet and background noise conditions (30, 40, 50, and 60 dB(A)) will be recorded during bone conduction headphone use with bilateral ear occlusion (BC+Occlusion) and compared with the corresponding BC condition without ear occlusion. |
Time Frame: During the study visit (approximately 1-2 hours).
|
Collaborateurs et enquêteurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- SAHZU-ACBC-001
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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