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Trial record 4 of 5 for:    Recruiting, Not yet recruiting, Available Studies | Cochlear nerve

Investigation of Anatomical Correlates of Speech Discrimination

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ClinicalTrials.gov Identifier: NCT01781039
Recruitment Status : Recruiting
First Posted : January 31, 2013
Last Update Posted : April 4, 2019
Sponsor:
Information provided by (Responsible Party):
Mark Parker, Steward St. Elizabeth's Medical Center of Boston, Inc.

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.

Condition or disease Intervention/treatment
Sensorineural Hearing Loss Device: Hearing Aid fitting

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Study Type : Observational
Estimated Enrollment : 1652 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Investigation of Anatomical Correlates of Speech Discrimination
Actual Study Start Date : January 2013
Estimated Primary Completion Date : January 2024
Estimated Study Completion Date : August 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hearing Aids

Group/Cohort Intervention/treatment
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
Device: 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.
Device: 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
Device: 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
Device: 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
Device: 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.




Primary Outcome Measures :
  1. Regression analysis [ Time Frame: June 2024 ]
    Regression analysis will be used to look for a correlation between measures of sensory cell and auditory neuron survival and speech recognition performance.



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Adult patients referred from the St. Elizabeth's Department of Otolaryngology and self-referred patients to the Audiology Clinic.
Criteria

Inclusion Criteria:

  • Normal hearing to moderate sensorineural hearing loss
  • Sufficient English proficiency to complete speech discrimination testing in English

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01781039


Locations
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United States, Massachusetts
Steward St. Elizabeth's Medical Center Recruiting
Brighton, Massachusetts, United States, 02135
Contact: Mark Parker, PhD    617-779-7956    mark.parker@steward.org   
Principal Investigator: Mark Parker, PhD         
Sponsors and Collaborators
Steward St. Elizabeth's Medical Center of Boston, Inc.
Investigators
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Principal Investigator: Mark Parker, PhD Steward St. Elizabeth's Medical Center
  Study Documents (Full-Text)

Documents provided by Mark Parker, Steward St. Elizabeth's Medical Center of Boston, Inc.:
Statistical Analysis Plan  [PDF] January 1, 2019


Additional Information:
Publications of Results:
Other Publications:
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Responsible Party: Mark Parker, Director of Audiology, St. Elizabeth's Medical Center, Steward St. Elizabeth's Medical Center of Boston, Inc.
ClinicalTrials.gov Identifier: NCT01781039     History of Changes
Other Study ID Numbers: 00652
First Posted: January 31, 2013    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mark Parker, Steward St. Elizabeth's Medical Center of Boston, Inc.:
"hair cell"
"hearing aid"
"hearing loss"
"auditory nerve"
synaptopathy
Additional relevant MeSH terms:
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Hearing Loss
Deafness
Hearing Loss, Sensorineural
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms