The Effect of Sound Stimulation on Pure-tone Hearing Threshold
Primary Purpose
Sensorineural Hearing Loss
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sound stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Sensorineural Hearing Loss
Eligibility Criteria
Inclusion Criteria:
- You are a male or female aged between 18 and 70 years
- You have 25~70 dB HL hearing loss at any frequency above 1.5 kHz
- You are able to use an mp3 player
- You are able to read English
Exclusion Criteria:
- Under the medications that could cause hearing loss (such as gentamicin, aspirin, ibuprofen, or acetaminophen)
- Chronic disease that could affect hearing (such as diabetes or high blood pressure)
- Temporal hearing loss
- Hearing loss more than 75 dB HL at any frequency
- Ear infections, chronic middle ear disease or any abnormality of the ear canal or ear drum
- Hearing aid user
- Pregnant females
Sites / Locations
- Earlogic Corporation
Outcomes
Primary Outcome Measures
Changes of pure-tone hearing thresholds after sound stimulation
Secondary Outcome Measures
Full Information
NCT ID
NCT01184248
First Posted
August 16, 2010
Last Updated
September 7, 2011
Sponsor
Earlogic Korea, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01184248
Brief Title
The Effect of Sound Stimulation on Pure-tone Hearing Threshold
Official Title
The Effect of Sound Stimulation on Pure-tone Hearing Threshold
Study Type
Interventional
2. Study Status
Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
January 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Earlogic Korea, Inc.
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to investigate if sound stimulation could improve pure-tone hearing threshold.
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.
Based on the results of animal studies, the investigators conducted a human study in 2007 and observed that sound stimulation could improve hearing ability. On average, the pure-tone hearing threshold decreased by 8.91 dB after sound stimulation for 2 weeks. In that study, however, the investigators observed only the hearing threshold changes by sound stimulation.
To verify the previous ameliorative effect of sound stimulation, the investigators included a control period in this study.
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
30 (Anticipated)
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
Time Frame
4-6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
You are a male or female aged between 18 and 70 years
You have 25~70 dB HL hearing loss at any frequency above 1.5 kHz
You are able to use an mp3 player
You are able to read English
Exclusion Criteria:
Under the medications that could cause hearing loss (such as gentamicin, aspirin, ibuprofen, or acetaminophen)
Chronic disease that could affect hearing (such as diabetes or high blood pressure)
Temporal hearing loss
Hearing loss more than 75 dB HL at any frequency
Ear infections, chronic middle ear disease or any abnormality of the ear canal or ear drum
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 Corporation
City
Los Angeles
State/Province
California
ZIP/Postal Code
90005
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
3170362
Citation
Canlon B, Borg E, Flock A. Protection against noise trauma by pre-exposure to a low level acoustic stimulus. Hear Res. 1988 Jul 15;34(2):197-200. doi: 10.1016/0378-5955(88)90107-4.
Results Reference
background
PubMed Identifier
1639725
Citation
Miyakita T, Hellstrom PA, Frimanson E, Axelsson A. Effect of low level acoustic stimulation on temporary threshold shift in young humans. Hear Res. 1992 Jul;60(2):149-55. doi: 10.1016/0378-5955(92)90017-h.
Results Reference
background
PubMed Identifier
16466871
Citation
Harris KC, Bielefeld E, Hu BH, Henderson D. Increased resistance to free radical damage induced by low-level sound conditioning. Hear Res. 2006 Mar;213(1-2):118-29. doi: 10.1016/j.heares.2005.11.012. Epub 2006 Feb 8.
Results Reference
background
PubMed Identifier
10444683
Citation
Kujawa SG, Liberman MC. Long-term sound conditioning enhances cochlear sensitivity. J Neurophysiol. 1999 Aug;82(2):863-73. doi: 10.1152/jn.1999.82.2.863.
Results Reference
background
PubMed Identifier
15316199
Citation
Niu X, Tahera Y, Canlon B. Protection against acoustic trauma by forward and backward sound conditioning. Audiol Neurootol. 2004 Sep-Oct;9(5):265-73. doi: 10.1159/000080226. Epub 2004 Aug 13.
Results Reference
background
PubMed Identifier
15659607
Citation
Norena AJ, Eggermont JJ. Enriched acoustic environment after noise trauma reduces hearing loss and prevents cortical map reorganization. J Neurosci. 2005 Jan 19;25(3):699-705. doi: 10.1523/JNEUROSCI.2226-04.2005.
Results Reference
background
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The Effect of Sound Stimulation on Pure-tone Hearing Threshold
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