- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00264407
Neural Changes in the Aging Auditory System
Age-Related Hearing Loss: Presbycusis & Its Neural Bases
Study Overview
Status
Intervention / Treatment
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
Enrollment
Contacts and Locations
Study Locations
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New York
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Rochester, New York, United States, 14642
- University of Rochester Medical Center
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Rochester, New York, United States, 14623-5604
- International Center Hearing & Speech Research - NTID - RIT
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Robert D Frisina, Ph.D., University of Rochester Medical School
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Neurocognitive Disorders
- Otorhinolaryngologic Diseases
- Ear Diseases
- Cognition Disorders
- Sensation Disorders
- Hearing Disorders
- Retrocochlear Diseases
- Auditory Diseases, Central
- Hearing Loss
- Perceptual Disorders
- Auditory Perceptual Disorders
- Physiological Effects of Drugs
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Hormones
Other Study ID Numbers
- 10121 (DAIDS ES Registry Number)
- P01AG009524 (NIH)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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