Neural Changes in the Aging Auditory System

NCT ID: NCT00264407

Last Updated: 2005-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

126 participants

Study Classification

OBSERVATIONAL

Study Start Date

2001-01-31

Study Completion Date

2005-02-28

Brief Summary

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

Detailed Description

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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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Conditions

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Progesterone Estrogens Hearing Psychoacoustics Auditory Perceptual Disorders

Keywords

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Hearing Loss, Central Presbycusis Hearing Loss, Sensorineural Hearing Loss, Cochlear Hearing Loss, Bilateral Sex Steroid Hormones Estradiol

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

OTHER

Interventions

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Hormone Replacement Therapy - HRT

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

60 Years

Maximum Eligible Age

86 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Rochester Institute of Technology

OTHER

Sponsor Role collaborator

National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

National Institute on Deafness and Other Communication Disorders (NIDCD)

NIH

Sponsor Role collaborator

University of Rochester

OTHER

Sponsor Role lead

Principal Investigators

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Robert D Frisina, Ph.D.

Role: STUDY_DIRECTOR

University of Rochester Medical School

Locations

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International Center Hearing & Speech Research - NTID - RIT

Rochester, New York, United States

Site Status

University of Rochester Medical Center

Rochester, New York, United States

Site Status

Countries

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United States

Other Identifiers

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P01AG009524

Identifier Type: NIH

Identifier Source: secondary_id

View Link

10121

Identifier Type: -

Identifier Source: org_study_id