Investigation of Anatomical Correlates of Speech Discrimination
1 other identifier
observational
186
1 country
1
Brief Summary
Understanding speech is essential for good communication. Individuals with hearing loss and poor speech discrimination often have little success with hearing aids because amplifying sound improves audibility, but not clarity of the speech signal. The purpose of this study is to determine the relative importance of the sensory cells of the inner ear and auditory neurons on speech discrimination performance in quiet and in noise. This information may be used as a predictor of hearing aid benefit. The investigators expect to find decreased speech understanding ability resulting from both loss of sensory cells and the loss of auditory neurons.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2013
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2013
CompletedFirst Submitted
Initial submission to the registry
January 29, 2013
CompletedFirst Posted
Study publicly available on registry
January 31, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 12, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 12, 2019
CompletedMarch 12, 2026
March 1, 2026
6.9 years
January 29, 2013
March 10, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Regression analysis
Regression analysis will be used to look for a correlation between measures of sensory cell and auditory neuron survival and speech recognition performance.
June 2024
Study Arms (7)
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
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
Hearing Aid fitting: MAD
Microphone adaptive directionality (MAD) feature will be activated, the WDC set to linear, and the DNR minimized
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: DNR
Digital noise reduction (DNR) set to maximum, MAD set to omnidirectional, and WDC set to linear
Hearing Aid fitting: Positive control
All hearing aid features enables
Hearing Aid fitting: Negative control
All hearing aid features disabled
Interventions
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
Adult patients referred from the St. Elizabeth's Department of Otolaryngology and self-referred patients to the Audiology Clinic.
You may qualify if:
- Normal hearing to moderate sensorineural hearing loss
- Sufficient English proficiency to complete speech discrimination testing in English
You may not qualify if:
- Hearing loss less than a 45 dB HL pure tone average (average hearing thresholds at 500, 1000 and 2000 Hz)
- Conductive hearing loss
- Neurodegenerative disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Steward St. Elizabeth's Medical Center
Brighton, Massachusetts, 02135, United States
Related Publications (3)
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.
PMID: 26055840RESULTHoben 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.
PMID: 28439223RESULTParker MA. Identifying three otopathologies in humans. Hear Res. 2020 Dec;398:108079. doi: 10.1016/j.heares.2020.108079. Epub 2020 Sep 24.
PMID: 33011456RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mark Parker, PhD
Steward St. Elizabeth's Medical Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 29, 2013
First Posted
January 31, 2013
Study Start
January 1, 2013
Primary Completion
December 12, 2019
Study Completion
December 12, 2019
Last Updated
March 12, 2026
Record last verified: 2026-03