Investigation of Anatomical Correlates of Speech Discrimination
NCT ID: NCT01781039
Last Updated: 2022-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
1652 participants
OBSERVATIONAL
2013-01-31
2026-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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low HIN difficulty- anesthetized
Subjects with normal OHC function and who will be undergoing an previously scheduled anesthetized procedure will be assigned into 2 groups based on their self-perceived HIN difficulty (high and low difficulty), and then undergo a test battery consisting of auditory threshold tests, objective HIN assays, OHC measurements, cognitive processing, and central auditory processing evaluations. Immediately after anesthetization, electrocochleography (ECochG) will be used to measure CAP amplitudes, which will be correlated with measurements obtained from unanesthetized subjects as described below. This aim will determine the optimal CAP recording method with the strongest correlation with HIN performance in humans
No interventions assigned to this group
high HIN difficulty- anesthetized
Subjects with normal OHC function and who will be undergoing an previously scheduled anesthetized procedure will be assigned into 2 groups based on their self-perceived HIN difficulty (high and low difficulty), and then undergo a test battery consisting of auditory threshold tests, objective HIN assays, OHC measurements, cognitive processing, and central auditory processing evaluations. Immediately after anesthetization, electrocochleography (ECochG) will be used to measure CAP amplitudes, which will be correlated with measurements obtained from unanesthetized subjects as described below. This aim will determine the optimal CAP recording method with the strongest correlation with HIN performance in humans
No interventions assigned to this group
Hearing Aid fitting: MAD
Microphone adaptive directionality (MAD) feature will be activated, the WDC set to linear, and the DNR minimized
Hearing Aid fitting
Subjects with hfPTAs ranging from 0-55 dB HL will be recruitedwith 100 persons self-reporting difficulty HIN (\> 50% of the time), and 100 persons reporting little difficulty HIN (\< 50% of the time) will be randomly assigned to one of five groups (n = 200) based on enabled HA features using an online random assignment tool. Unaided HIQ and HIN assessments will be conducted in the sound field, and baseline DPOAE and CAP assessments will be measured. Subjects will be fit with binaural premium level receiver-in-the canal HAs (Phonak B90 or equivalent model at the start of the study) with 56 dB SPL gain receivers, using closed domes, and programmed to NAL-NL2 target gain, and randomly assigned to the groups.
Hearing Aid fitting: WDC
Wide dynamic compression (WDC) feature will be set to target levels, the MAD feature set to omnidirectional, and the DNR minimized.
Hearing Aid fitting
Subjects with hfPTAs ranging from 0-55 dB HL will be recruitedwith 100 persons self-reporting difficulty HIN (\> 50% of the time), and 100 persons reporting little difficulty HIN (\< 50% of the time) will be randomly assigned to one of five groups (n = 200) based on enabled HA features using an online random assignment tool. Unaided HIQ and HIN assessments will be conducted in the sound field, and baseline DPOAE and CAP assessments will be measured. Subjects will be fit with binaural premium level receiver-in-the canal HAs (Phonak B90 or equivalent model at the start of the study) with 56 dB SPL gain receivers, using closed domes, and programmed to NAL-NL2 target gain, and randomly assigned to the groups.
Hearing Aid fitting: DNR
Digital noise reduction (DNR) set to maximum, MAD set to omnidirectional, and WDC set to linear
Hearing Aid fitting
Subjects with hfPTAs ranging from 0-55 dB HL will be recruitedwith 100 persons self-reporting difficulty HIN (\> 50% of the time), and 100 persons reporting little difficulty HIN (\< 50% of the time) will be randomly assigned to one of five groups (n = 200) based on enabled HA features using an online random assignment tool. Unaided HIQ and HIN assessments will be conducted in the sound field, and baseline DPOAE and CAP assessments will be measured. Subjects will be fit with binaural premium level receiver-in-the canal HAs (Phonak B90 or equivalent model at the start of the study) with 56 dB SPL gain receivers, using closed domes, and programmed to NAL-NL2 target gain, and randomly assigned to the groups.
Hearing Aid fitting: Positive control
All hearing aid features enables
Hearing Aid fitting
Subjects with hfPTAs ranging from 0-55 dB HL will be recruitedwith 100 persons self-reporting difficulty HIN (\> 50% of the time), and 100 persons reporting little difficulty HIN (\< 50% of the time) will be randomly assigned to one of five groups (n = 200) based on enabled HA features using an online random assignment tool. Unaided HIQ and HIN assessments will be conducted in the sound field, and baseline DPOAE and CAP assessments will be measured. Subjects will be fit with binaural premium level receiver-in-the canal HAs (Phonak B90 or equivalent model at the start of the study) with 56 dB SPL gain receivers, using closed domes, and programmed to NAL-NL2 target gain, and randomly assigned to the groups.
Hearing Aid fitting: Negative control
All hearing aid features disabled
Hearing Aid fitting
Subjects with hfPTAs ranging from 0-55 dB HL will be recruitedwith 100 persons self-reporting difficulty HIN (\> 50% of the time), and 100 persons reporting little difficulty HIN (\< 50% of the time) will be randomly assigned to one of five groups (n = 200) based on enabled HA features using an online random assignment tool. Unaided HIQ and HIN assessments will be conducted in the sound field, and baseline DPOAE and CAP assessments will be measured. Subjects will be fit with binaural premium level receiver-in-the canal HAs (Phonak B90 or equivalent model at the start of the study) with 56 dB SPL gain receivers, using closed domes, and programmed to NAL-NL2 target gain, and randomly assigned to the groups.
Interventions
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Hearing Aid fitting
Subjects with hfPTAs ranging from 0-55 dB HL will be recruitedwith 100 persons self-reporting difficulty HIN (\> 50% of the time), and 100 persons reporting little difficulty HIN (\< 50% of the time) will be randomly assigned to one of five groups (n = 200) based on enabled HA features using an online random assignment tool. Unaided HIQ and HIN assessments will be conducted in the sound field, and baseline DPOAE and CAP assessments will be measured. Subjects will be fit with binaural premium level receiver-in-the canal HAs (Phonak B90 or equivalent model at the start of the study) with 56 dB SPL gain receivers, using closed domes, and programmed to NAL-NL2 target gain, and randomly assigned to the groups.
Eligibility Criteria
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Inclusion Criteria
* Sufficient English proficiency to complete speech discrimination testing in English
Exclusion Criteria
* Conductive hearing loss
* Neurodegenerative disease
18 Years
100 Years
ALL
Yes
Sponsors
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Steward St. Elizabeth's Medical Center of Boston, Inc.
OTHER
Responsible Party
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Mark Parker
Director of Audiology, St. Elizabeth's Medical Center
Principal Investigators
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Mark Parker, PhD
Role: PRINCIPAL_INVESTIGATOR
Steward St. Elizabeth's Medical Center
Locations
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Steward St. Elizabeth's Medical Center
Brighton, Massachusetts, United States
Countries
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Facility Contacts
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Mark Parker, PhD
Role: primary
References
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Bramhall N, Ong B, Ko J, Parker M. Speech Perception Ability in Noise is Correlated with Auditory Brainstem Response Wave I Amplitude. J Am Acad Audiol. 2015 May;26(5):509-517. doi: 10.3766/jaaa.14100.
Hoben R, Easow G, Pevzner S, Parker MA. Outer Hair Cell and Auditory Nerve Function in Speech Recognition in Quiet and in Background Noise. Front Neurosci. 2017 Apr 7;11:157. doi: 10.3389/fnins.2017.00157. eCollection 2017.
Parker MA. Identifying three otopathologies in humans. Hear Res. 2020 Dec;398:108079. doi: 10.1016/j.heares.2020.108079. Epub 2020 Sep 24.
Provided Documents
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Document Type: Study Protocol and Informed Consent Form
Document Type: Statistical Analysis Plan
Related Links
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Peer reviewed publication
Peer reviewed publication
Peer reviewed publication
Other Identifiers
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00652
Identifier Type: -
Identifier Source: org_study_id