Neural Changes in the Aging Auditory System

Progesterone Clinical Trial

Official title:

Age-Related Hearing Loss: Presbycusis & Its Neural Bases

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00264407
• Other study ID #: 10121
• Secondary ID: P01AG009524
• Status: Completed
• Phase: Phase 1
• First received: December 8, 2005
• Last updated: December 8, 2005
• Start date: January 2001
• Est. completion date: February 2005

Study information

• Verified date: December 2005
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: February 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 60 Years to 86 Years

Eligibility

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)

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Auditory Perceptual Disorders
• Estrogens
• Hearing
• Perceptual Disorders
• Progesterone
• Psychoacoustics

Intervention

Drug:
• Hormone Replacement Therapy - HRT

Locations

Country	Name	City	State
United States	International Center Hearing & Speech Research - NTID - RIT	Rochester	New York
United States	University of Rochester Medical Center	Rochester	New York

Sponsors (4)

Lead Sponsor	Collaborator
University of Rochester	National Institute on Aging (NIA), National Institute on Deafness and Other Communication Disorders (NIDCD), Rochester Institute of Technology

Country where clinical trial is conducted

United States,