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The Effect of Sound Stimulation on Hearing Ability

Primary Purpose

Sensorineural Hearing Loss

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Sound stimulation
Sponsored by
Earlogic Korea, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sensorineural Hearing Loss

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Male and female
  • Age between 20 and 70 years
  • Subjects should be able to use an mp3 player

Exclusion Criteria:

  • Hearing loss more than 70 dB HL at any frequency
  • More than 10 dB of air-bone gaps at more than 3 frequencies in pure-tone audiometry
  • Ear infections, chronic middle ear disease or any abnormality of the ear canal or ear drum
  • Temporary hearing loss
  • Hearing aid user
  • Pregnant females

Sites / Locations

  • Earlogic Auditory Research Institute

Outcomes

Primary Outcome Measures

Changes of pure-tone hearing thresholds after sound stimulation
Pure-tone hearing thresholds of the baseline and the final point (after 2~6 months)will be compared.

Secondary Outcome Measures

Full Information

First Posted
September 9, 2011
Last Updated
April 2, 2012
Sponsor
Earlogic Korea, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01434446
Brief Title
The Effect of Sound Stimulation on Hearing Ability
Official Title
The Effect of Sound Stimulation on Hearing Ability
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Earlogic Korea, Inc.

4. Oversight

5. Study Description

Brief Summary
In the late 1990s, researchers discovered that acoustic stimuli slow progressive sensorineural hearing loss and exposure to a moderately augmented acoustic environment can delay the loss of auditory function. In addition, prolonged exposure to an augmented acoustic environment could improve age-related auditory changes. These ameliorative effects were shown in several types of mouse strains, as long as the acoustic environment was provided prior to the occurrence of severe hearing loss. In addition to delaying progressive hearing loss, acoustic stimuli could also protect hearing ability against damage by traumatic noise. In particular, a method called forward sound conditioning (i.e., prior exposure to moderate levels of sound) has been shown to reduce noise-induced hearing impairment in a number of mammalian species, including humans. Interestingly, recent report has suggested that low-level sound conditioning also reduces free radical-induced damage to hair cells, increases antioxidant enzyme activity, and reduces Cox-2 expression in cochlea, and can enhance cochlear sensitivity. Specifically, increased cochlear sensitivity was observed when distortion product otoacoustic emissions (DPOAEs) and compound action potentials (CAPs) were measured. In addition to forward sound conditioning, backward sound conditioning (i.e., the use of acoustic stimuli after exposure to a traumatic noise) has been shown to protect hearing ability against acoustic trauma and to prevent the cortical map reorganization induced by traumatic noise. In this study, the investigators examine the effect of sound stimulation on hearing ability in human subjects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sensorineural Hearing Loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Sound stimulation
Intervention Description
Listening to sound stimuli at the lowest audible level.
Primary Outcome Measure Information:
Title
Changes of pure-tone hearing thresholds after sound stimulation
Description
Pure-tone hearing thresholds of the baseline and the final point (after 2~6 months)will be compared.
Time Frame
2~6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Male and female Age between 20 and 70 years Subjects should be able to use an mp3 player Exclusion Criteria: Hearing loss more than 70 dB HL at any frequency More than 10 dB of air-bone gaps at more than 3 frequencies in pure-tone audiometry Ear infections, chronic middle ear disease or any abnormality of the ear canal or ear drum Temporary hearing loss Hearing aid user Pregnant females
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eunyee Kwak, Ph.D.
Organizational Affiliation
Earlogic Auditory Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Earlogic Auditory Research Institute
City
Seoul
ZIP/Postal Code
121-270
Country
Korea, Republic of

12. IPD Sharing Statement

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The Effect of Sound Stimulation on Hearing Ability

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