Neural Changes in the Aging Auditory System

This study has been completed.
Sponsor:
Collaborators:
Rochester Institute of Technology
Information provided by:
University of Rochester
ClinicalTrials.gov Identifier:
NCT00264407
First received: December 8, 2005
Last updated: NA
Last verified: December 2005
History: No changes posted
  Purpose

The purpose of this study was to determine the effects of hormone replacement therapy (HRT) on hearing in post-menopausal women.


Condition Intervention Phase
Progesterone
Estrogens
Hearing
Psychoacoustics
Auditory Perceptual Disorders
Drug: Hormone Replacement Therapy - HRT
Phase 1

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Age-Related Hearing Loss: Presbycusis & Its Neural Bases

Resource links provided by NLM:


Further study details as provided by University of Rochester:

Estimated Enrollment: 126
Study Start Date: January 2001
Estimated Study Completion Date: February 2005
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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  Eligibility

Ages Eligible for Study:   60 Years to 86 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00264407

Locations
United States, New York
University of Rochester Medical Center
Rochester, New York, United States, 14642
International Center Hearing & Speech Research - NTID - RIT
Rochester, New York, United States, 14623-5604
Sponsors and Collaborators
University of Rochester
Rochester Institute of Technology
Investigators
Study Director: Robert D Frisina, Ph.D. University of Rochester Medical School
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00264407     History of Changes
Other Study ID Numbers: 10121, P01 AG09524
Study First Received: December 8, 2005
Last Updated: December 8, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Rochester:
Hearing Loss, Central
Presbycusis
Hearing Loss, Sensorineural
Hearing Loss, Cochlear
Hearing Loss, Bilateral
Sex Steroid Hormones
Estradiol

Additional relevant MeSH terms:
Auditory Perceptual Disorders
Hearing Loss
Deafness
Perceptual Disorders
Presbycusis
Auditory Diseases, Central
Retrocochlear Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Cognition Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Hearing Disorders
Sensation Disorders
Hearing Loss, Sensorineural
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014