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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 : January 17, 2018
Information provided by (Responsible Party):

Study Description
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
Sensorineural Hearing Loss

Study Design

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Study Start Date : January 2013
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :
  1. Regression analysis [ Time Frame: February 2014 ]
    Regression analysis will be used to look for a correlation between measures of sensory cell and auditory neuron survival and speech recognition performance.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
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.

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
Contacts and Locations

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

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         
Sub-Investigator: Richard Hoben, AuD         
Sponsors and Collaborators
Steward St. Elizabeth's Medical Center of Boston, Inc.
Principal Investigator: Mark Parker, PhD Steward St. Elizabeth's Medical Center
More Information

Additional Information:
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: January 17, 2018
Last Verified: January 2018

Keywords provided by Mark Parker, Steward St. Elizabeth's Medical Center of Boston, Inc.:
"hair cell"
"hearing aid"
"hearing loss"
"auditory nerve"

Additional relevant MeSH terms:
Hearing Loss
Hearing Loss, Sensorineural
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms