Investigation of Anatomical Correlates of Speech Discrimination

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Steward St. Elizabeth's Medical Center of Boston, Inc.
Sponsor:
Information provided by (Responsible Party):
Mark Parker, Steward St. Elizabeth's Medical Center of Boston, Inc.
ClinicalTrials.gov Identifier:
NCT01781039
First received: January 29, 2013
Last updated: June 5, 2014
Last verified: June 2014
  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 Steward St. Elizabeth's Medical Center of Boston, Inc.:

Primary Outcome Measures:
  • Regression analysis [ Time Frame: February 2014 ] [ Designated as safety issue: No ]
    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 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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 with greater 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: January 29, 2013
Last Updated: June 5, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 18, 2014