- ICH GCP
- USA klinikai vizsgálatok nyilvántartása
- Klinikai vizsgálat NCT07933991
Effects of Auditory Fatigue on Central Auditory Processing in Adults With Normal Hearing
Investigation of the Effects of Auditory Fatigue on Central Auditory Processing Performance
This study aims to investigate how auditory fatigue caused by a prolonged and demanding listening task affects central auditory processing abilities in adults with normal hearing. Central auditory processing refers to how the brain processes and interprets sounds, including the ability to recognize differences in sound timing and patterns.
A total of 60 adults aged 18-40 years will participate. Participants will be divided into two groups based on their occupational listening demands. One group will include 30 individuals working in professions that require frequent and sustained verbal communication, such as simultaneous interpreters, speech and language therapists, special education teachers, and psychologists. The comparison group will include 30 individuals whose occupations do not require intensive and continuous verbal communication.
All participants will undergo hearing assessments and central auditory processing tests before and after a 60-minute listening task involving Turkish speech materials presented with background noise from multiple speakers. Participants will also rate their perceived auditory fatigue, listening effort, and task demands before and after the listening task.
The study will examine changes in auditory processing performance following the listening task and determine whether these changes differ between the two occupational groups. The findings may help researchers and clinicians better understand how auditory fatigue influences auditory processing test results.
A tanulmány áttekintése
Állapot
Körülmények
Beavatkozás / kezelés
Részletes leírás
Central auditory processing involves the neural mechanisms responsible for analyzing and interpreting auditory information beyond peripheral hearing sensitivity. Temporal resolution and temporal pattern recognition are important components of central auditory processing and can be assessed using behavioral auditory tests.
Prolonged listening under demanding conditions may increase listening effort and the use of cognitive resources, potentially contributing to auditory fatigue. Although previous research has investigated listening effort and fatigue in relation to speech perception, cognitive demands, and subjective experiences, evidence regarding the effects of experimentally induced acute auditory fatigue on behavioral central auditory processing performance remains limited.
This study is designed as a non-randomized, quasi-experimental, pretest-posttest investigation involving two groups with different occupational listening demands. The study will include 60 adults aged 18-40 years with normal peripheral hearing, with 30 participants in each group.
The first group will consist of individuals employed in occupations requiring sustained verbal communication, active speech listening, and auditory attention, including simultaneous interpreters, speech and language therapists, special education teachers, and psychologists conducting regular client consultations. The comparison group will consist of individuals whose occupational responsibilities do not require intensive and continuous verbal communication. The groups will be matched as closely as possible in terms of age, sex, and educational level.
Before the experimental listening task, participants will undergo otoscopic examination, tympanometry, pure-tone audiometry, and speech audiometry to assess peripheral hearing status and determine eligibility.
Central auditory processing performance will be assessed using three behavioral tests:
- Gaps-in-Noise Test (GIN), assessing temporal resolution.
- Frequency Pattern Test (FPT), assessing temporal pattern recognition based on frequency patterns.
- Duration Pattern Test (DPT), assessing temporal pattern recognition based on duration patterns.
Participants will also complete Visual Analog Scale (VAS) assessments of perceived auditory fatigue, listening effort, and task demands.
Following baseline assessments, all participants will complete a standardized 60-minute experimental listening task developed using Turkish Hearing in Noise Test (HINT-TR) speech materials presented with multi-talker babble noise. The task is intended to induce acute auditory fatigue under controlled listening conditions.
Immediately after the listening task, the GIN, FPT, and DPT assessments will be repeated. Subjective auditory fatigue, listening effort, and perceived task demands will also be reassessed using VAS measures.
The primary analyses will examine changes in central auditory processing performance before and after the listening task and evaluate whether these changes differ between occupational groups. Group, time, and group-by-time interaction effects will be investigated using mixed-design repeated-measures analysis of variance when statistical assumptions are satisfied. Associations between changes in subjective measures and behavioral auditory processing performance will also be examined using appropriate correlation analyses.
All participants will undergo the same standardized assessment procedures and experimental listening protocol. Familiarization procedures and standardized testing conditions will be used to reduce potential measurement variability and practice effects.
The study is expected to contribute to understanding the relationship between experimentally induced auditory fatigue and central auditory processing performance and may provide useful information for interpreting behavioral central auditory processing assessments in clinical and research settings.
Tanulmány típusa
Beiratkozás (Becsült)
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Tanulmányi kapcsolat
- Név: Büşra Özbay Sekibağ, MSc., Aud.
- Telefonszám: 90212 210 10 10
- E-mail: busra.ozbay@nisantasi.edu.tr
Tanulmányi helyek
-
-
Istanbul
-
Istanbul, Istanbul, Törökország (Türkiye)
- Istanbul Nisantasi University, NeoTech Campus Audiometry Laboratory
-
Kapcsolatba lépni:
- Büşra Özbay Sekibağ, MSc., Aud.
- Telefonszám: 902122101010
- E-mail: busra.ozbay@nisantasi.edu.tr
-
Kutatásvezető:
- Burak Ömür Çakır, Prof. of Otolaryngology
-
Alkutató:
- Büşra Özbay Sekibağ, MSc., Aud.
-
-
Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
Egészséges önkénteseket fogad
Tanulmányozható nemek
Leírás
Inclusion Criteria:
- Adults aged between 18 and 40 years.
- Willingness to participate in the study and provision of written informed consent.
- Completion of the online participation form.
- Sufficient proficiency in Turkish to understand instructions and complete the auditory assessments.
- Bilaterally normal otoscopic findings.
- Normal middle ear function as determined by tympanometric assessment.
- Normal hearing thresholds on pure-tone audiometry.
- For the high occupational listening demands group: Current employment as a simultaneous interpreter, speech and language therapist, special education teacher, or psychologist, with regular occupational responsibilities requiring sustained verbal communication, active speech listening, and auditory attention. Psychologists must actively conduct client consultations.
- For the comparison group: Current employment in occupations that do not require intensive and sustained verbal communication or continuous active speech listening.
Exclusion Criteria:
- Presence of peripheral hearing loss.
- Active external or middle ear pathology.
- History of a known neurological disorder that may affect central auditory processing performance.
- Any condition that may prevent reliable completion of the auditory assessments or experimental listening protocol.
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Alapvető tudomány
- Kiosztás: Nem véletlenszerű
- Beavatkozó modell: Egyetlen csoportos hozzárendelés
- Maszkolás: Kettős
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
|---|---|
|
Kísérleti: High Occupational Listening Demands
This arm will include 30 adults aged 18-40 years with normal peripheral hearing who work in occupations requiring sustained verbal communication, active speech listening, and auditory attention. Participants will include simultaneous interpreters, speech and language therapists, special education teachers, and psychologists conducting regular client consultations. All participants will complete a standardized 60-minute experimental auditory fatigue listening task. Central auditory processing performance will be assessed using the Gaps-in-Noise Test (GIN), Frequency Pattern Test (FPT), and Duration Pattern Test (DPT) before and after the listening task. Perceived auditory fatigue, listening effort, and task demands will also be evaluated using Visual Analog Scales (VAS). |
All participants will complete a standardized 60-minute experimental listening task designed to induce acute auditory fatigue. The task will involve sustained listening to Turkish Hearing in Noise Test (HINT-TR) speech materials presented with multi-talker babble noise. The same listening protocol will be administered to participants in both occupational groups under standardized conditions. The intervention will be performed once, following baseline auditory assessments. Immediately after the task, central auditory processing performance will be reassessed using the GIN, FPT, and DPT. Subjective auditory fatigue, listening effort, and perceived task demands will also be evaluated using Visual Analog Scales (VAS) before and after the intervention. |
|
Kísérleti: Non-Intensive Occupational Listening Demands
This arm will include 30 adults aged 18-40 years with normal peripheral hearing whose occupations do not require intensive and sustained verbal communication or continuous active speech listening. Participants will be selected to achieve comparable age, sex, and educational characteristics between occupational groups where possible. All participants will complete the same standardized 60-minute experimental auditory fatigue listening task administered to the high occupational listening demands group. Central auditory processing performance will be assessed using the Gaps-in-Noise Test (GIN), Frequency Pattern Test (FPT), and Duration Pattern Test (DPT) before and after the listening task. Perceived auditory fatigue, listening effort, and task demands will also be evaluated using Visual Analog Scales (VAS). |
All participants will complete a standardized 60-minute experimental listening task designed to induce acute auditory fatigue. The task will involve sustained listening to Turkish Hearing in Noise Test (HINT-TR) speech materials presented with multi-talker babble noise. The same listening protocol will be administered to participants in both occupational groups under standardized conditions. The intervention will be performed once, following baseline auditory assessments. Immediately after the task, central auditory processing performance will be reassessed using the GIN, FPT, and DPT. Subjective auditory fatigue, listening effort, and perceived task demands will also be evaluated using Visual Analog Scales (VAS) before and after the intervention. |
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Gaps-in-Noise Test (GIN)
Időkeret: Baseline (before the listening task) and immediately after the 60-minute listening task, during the same study visit.
|
Temporal resolution will be assessed using the Gaps-in-Noise (GIN) Test. The outcome will be the change in gap detection threshold, measured in milliseconds (ms), calculated as the post-intervention threshold minus the baseline threshold. Lower thresholds indicate better temporal resolution. Changes will be compared between the two occupational groups. |
Baseline (before the listening task) and immediately after the 60-minute listening task, during the same study visit.
|
|
Frequency Pattern Test (FPT)
Időkeret: Baseline (before the listening task) and immediately after the 60-minute listening task, during the same study visit.
|
Temporal pattern recognition based on frequency variations will be assessed using the Frequency Pattern Test (FPT). Performance will be expressed as the percentage of correctly identified frequency patterns, ranging from 0% to 100%. The outcome will be calculated as the post-intervention percentage minus the baseline percentage. Higher percentages indicate better performance. Changes will be compared between occupational groups. |
Baseline (before the listening task) and immediately after the 60-minute listening task, during the same study visit.
|
|
Duration Pattern Test (DPT)
Időkeret: Baseline (before the listening task) and immediately after the 60-minute listening task, during the same study visit.
|
Temporal pattern recognition based on sound duration will be assessed using the Duration Pattern Test (DPT). Performance will be expressed as the percentage of correctly identified duration patterns, ranging from 0% to 100%. The outcome will be calculated as the post-intervention percentage minus the baseline percentage. Higher percentages indicate better performance. Changes will be compared between occupational groups. |
Baseline (before the listening task) and immediately after the 60-minute listening task, during the same study visit.
|
Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Perceived Auditory Fatigue (VAS)
Időkeret: Baseline (before the listening task) and immediately after the 60-minute listening task, during the same study visit.
|
Perceived auditory fatigue will be assessed using a 100-mm Visual Analog Scale (VAS) before and immediately after the experimental listening task. Participants will rate their perceived level of auditory fatigue on a continuous scale ranging from 0 mm (no auditory fatigue at all) to 100 mm (extreme auditory fatigue). Higher scores indicate greater perceived auditory fatigue. The outcome will be calculated as the post-intervention VAS score minus the baseline VAS score, expressed in millimeters (mm). Positive change scores indicate an increase in perceived auditory fatigue following the listening task. |
Baseline (before the listening task) and immediately after the 60-minute listening task, during the same study visit.
|
|
Perceived Listening Effort (VAS)
Időkeret: Baseline (before the listening task) and immediately after the 60-minute listening task, during the same study visit.
|
Perceived listening effort will be assessed using a 100-mm Visual Analog Scale (VAS) before and immediately after the experimental listening task. Participants will rate their perceived level of listening effort on a continuous scale ranging from 0 mm (no listening effort at all) to 100 mm (extremely high listening effort). Higher scores indicate greater perceived listening effort. The outcome will be calculated as the post-intervention VAS score minus the baseline VAS score, expressed in millimeters (mm). Positive change scores indicate an increase in perceived listening effort following the listening task. |
Baseline (before the listening task) and immediately after the 60-minute listening task, during the same study visit.
|
Együttműködők és nyomozók
Szponzor
Együttműködők
Publikációk és hasznos linkek
Általános kiadványok
- McGarrigle R, Munro KJ, Dawes P, Stewart AJ, Moore DR, Barry JG, Amitay S. Listening effort and fatigue: what exactly are we measuring? A British Society of Audiology Cognition in Hearing Special Interest Group 'white paper'. Int J Audiol. 2014 Jul;53(7):433-40. doi: 10.3109/14992027.2014.890296. Epub 2014 Mar 27.
- Hornsby BWY, Camarata S, Cho SJ, Davis H, McGarrigle R, Bess FH. Development and Validation of a Brief Version of the Vanderbilt Fatigue Scale for Adults: The VFS-A-10. Ear Hear. 2023 Sep-Oct 01;44(5):1251-1261. doi: 10.1097/AUD.0000000000001369. Epub 2023 Apr 27.
- Francis AL, Love J. Listening effort: Are we measuring cognition or affect, or both? Wiley Interdiscip Rev Cogn Sci. 2020 Jan;11(1):e1514. doi: 10.1002/wcs.1514. Epub 2019 Aug 5.
- Hornsby BW, Naylor G, Bess FH. A Taxonomy of Fatigue Concepts and Their Relation to Hearing Loss. Ear Hear. 2016 Jul-Aug;37 Suppl 1(Suppl 1):136S-44S. doi: 10.1097/AUD.0000000000000289.
- Pichora-Fuller MK, Kramer SE, Eckert MA, Edwards B, Hornsby BW, Humes LE, Lemke U, Lunner T, Matthen M, Mackersie CL, Naylor G, Phillips NA, Richter M, Rudner M, Sommers MS, Tremblay KL, Wingfield A. Hearing Impairment and Cognitive Energy: The Framework for Understanding Effortful Listening (FUEL). Ear Hear. 2016 Jul-Aug;37 Suppl 1:5S-27S. doi: 10.1097/AUD.0000000000000312.
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Becsült)
Elsődleges befejezés (Becsült)
A tanulmány befejezése (Becsült)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
Egyéb vizsgálati azonosító számok
- BOS_IAUPhD
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
IPD terv leírása
Individual participant data will not be shared with researchers outside the study team. Study data will be coded and securely stored in accordance with the approved research protocol and applicable data protection regulations. Only authorized members of the research team will have access to individual-level data. Study findings may be published in aggregate form without identifying individual participants.
Gyógyszer- és eszközinformációk, tanulmányi dokumentumok
Egy amerikai FDA által szabályozott gyógyszerkészítményt tanulmányoz
Egy amerikai FDA által szabályozott eszközterméket tanulmányoz
Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .