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The Effect of Sound Stimulation on Pure-tone Hearing Threshold

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01184248
Recruitment Status : Completed
First Posted : August 18, 2010
Last Update Posted : September 8, 2011
Sponsor:
Information provided by (Responsible Party):
Earlogic Korea, Inc.

Tracking Information
First Submitted Date  ICMJE August 16, 2010
First Posted Date  ICMJE August 18, 2010
Last Update Posted Date September 8, 2011
Study Start Date  ICMJE May 2010
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 17, 2010)
Changes of pure-tone hearing thresholds after sound stimulation [ Time Frame: 4-6 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Sound Stimulation on Pure-tone Hearing Threshold
Official Title  ICMJE The Effect of Sound Stimulation on Pure-tone Hearing Threshold
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Sensorineural Hearing Loss
Intervention  ICMJE Behavioral: Sound stimulation
Listening to sound stimuli at the lowest audible level.
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: August 17, 2010)
30
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2011
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01184248
Other Study ID Numbers  ICMJE IEK14152010
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Earlogic Korea, Inc.
Study Sponsor  ICMJE Earlogic Korea, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Eunyee Kwak, Ph.D. Earlogic Auditory Research Institute
PRS Account Earlogic Korea, Inc.
Verification Date September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP