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Neural Changes in the Aging Auditory System

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00264407
Recruitment Status : Completed
First Posted : December 12, 2005
Last Update Posted : December 12, 2005
Sponsor:
Collaborators:
Rochester Institute of Technology
National Institute on Aging (NIA)
National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by:
University of Rochester

Tracking Information
First Submitted Date December 8, 2005
First Posted Date December 12, 2005
Last Update Posted Date December 12, 2005
Study Start Date January 2001
Primary Completion Date Not Provided
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Neural Changes in the Aging Auditory System
Official Title Age-Related Hearing Loss: Presbycusis & Its Neural Bases
Brief Summary The purpose of this study was to determine the effects of hormone replacement therapy (HRT) on hearing in post-menopausal women.
Detailed Description

Background: Female hormone influences on the development and aging of the auditory system are not completely understood. The present study retrospectively analyzed and compared hearing abilities among post-menopausal women taking hormone replacement therapy (HRT), treated with estrogen and progesterone (E+P); estrogen alone (E), and a third (control - NHRT) group, matched for age, who did not receive any HRT.

Methods: 126 subjects, (60-86 yr), N=32, E+P; N=31, E; N= 63, NHRT; matched for age and health status participated. All had relatively healthy medical histories, absence of significant noise exposure, middle ear problems, major surgeries or current/heavy smoking. Hearing tests included pure tone audiometry (PTA), tympanometry, distortion-product otoacoustic emissions (DPOAEs), transient otoacoustic emissions (TEOAEs) and hearing-in-noise-test (HINT). The latter is a test for speech perception in background noise: the major complaint of hearing-impaired persons.

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Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Not Provided
Study Population Not Provided
Condition
  • Progesterone
  • Estrogens
  • Hearing
  • Psychoacoustics
  • Auditory Perceptual Disorders
Intervention Drug: Hormone Replacement Therapy - HRT
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Enrollment
 (submitted: December¬†8,¬†2005)
126
Original Enrollment Same as current
Study Completion Date February 2005
Primary Completion Date Not Provided
Eligibility Criteria

Inclusion Criteria:

  • Healthy middle ears

Exclusion Criteria:

  • ototoxic medications
  • serious medical health problems
  • neurological conditions
  • Meniere's disease or labyrinthitis
  • those who failed cognitive screening tests (Mini-Mental Test)
  • current/heavy smokers
  • conductive hearing loss
  • history of noise damage and/or audiograms signifying noise damage
  • poor speech discrimination scores (80% or less)
Sex/Gender
Sexes Eligible for Study: Female
Ages 60 Years to 86 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00264407
Other Study ID Numbers 10121
P01AG009524 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party Not Provided
Original Responsible Party Same as current
Current Study Sponsor University of Rochester
Original Study Sponsor Same as current
Collaborators
  • Rochester Institute of Technology
  • National Institute on Aging (NIA)
  • National Institute on Deafness and Other Communication Disorders (NIDCD)
Investigators
Study Director: Robert D Frisina, Ph.D. University of Rochester Medical School
PRS Account University of Rochester
Verification Date December 2005