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Investigation of Anatomical Correlates of Speech Discrimination

This study is currently recruiting participants.
Verified November 2016 by Mark Parker, Steward St. Elizabeth's Medical Center of Boston, Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01781039
First Posted: January 31, 2013
Last Update Posted: November 25, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Mark Parker, Steward St. Elizabeth's Medical Center of Boston, Inc.
  Purpose
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
Sensorineural Hearing Loss

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional

Resource links provided by NLM:


Further study details as provided by Mark Parker, Steward St. Elizabeth's Medical Center of Boston, Inc.:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 100
Study Start Date: January 2013
Estimated Study Completion Date: August 2019
Estimated Primary Completion Date: January 2019 (Final data collection date for primary outcome measure)
  Eligibility

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.
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
  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


Locations
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   
Sub-Investigator: Naomi Bramhall, PhD         
Sub-Investigator: Michael Dybka, PhD         
Principal Investigator: Mark Parker, PhD         
Sponsors and Collaborators
Steward St. Elizabeth's Medical Center of Boston, Inc.
Investigators
Principal Investigator: Mark Parker, PhD Steward St. Elizabeth's Medical Center
  More Information

Additional Information:
Publications:
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 Submitted: January 29, 2013
First Posted: January 31, 2013
Last Update Posted: November 25, 2016
Last Verified: November 2016

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

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