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The Effect of Sound Stimulation on Hearing Ability

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: NCT01434446
Recruitment Status : Completed
First Posted : September 15, 2011
Last Update Posted : April 3, 2012
Sponsor:
Information provided by (Responsible Party):
Earlogic Korea, Inc.

Tracking Information
First Submitted Date  ICMJE September 9, 2011
First Posted Date  ICMJE September 15, 2011
Last Update Posted Date April 3, 2012
Study Start Date  ICMJE September 2011
Actual Primary Completion Date February 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 14, 2011)
Changes of pure-tone hearing thresholds after sound stimulation [ Time Frame: 2~6 months ]
Pure-tone hearing thresholds of the baseline and the final point (after 2~6 months)will be compared.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01434446 on ClinicalTrials.gov Archive Site
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 Hearing Ability
Official Title  ICMJE The Effect of Sound Stimulation on Hearing Ability
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.

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 * Not Provided

*   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
Actual Enrollment  ICMJE
 (submitted: April 2, 2012)
21
Original Estimated Enrollment  ICMJE
 (submitted: September 14, 2011)
60
Actual Study Completion Date  ICMJE April 2012
Actual Primary Completion Date February 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01434446
Other Study ID Numbers  ICMJE IEK 08252011
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 April 2012

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