The Effect of Sound Stimulation on Hearing Ability

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Earlogic Korea, Inc.
ClinicalTrials.gov Identifier:
NCT01434446
First received: September 9, 2011
Last updated: April 2, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention
Sensorineural Hearing Loss
Behavioral: Sound stimulation

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effect of Sound Stimulation on Hearing Ability

Resource links provided by NLM:


Further study details as provided by Earlogic Korea, Inc.:

Primary Outcome Measures:
  • Changes of pure-tone hearing thresholds after sound stimulation [ Time Frame: 2~6 months ] [ Designated as safety issue: No ]
    Pure-tone hearing thresholds of the baseline and the final point (after 2~6 months)will be compared.


Enrollment: 21
Study Start Date: September 2011
Study Completion Date: April 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Sound stimulation
    Listening to sound stimuli at the lowest audible level.
  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01434446

Locations
Korea, Republic of
Earlogic Auditory Research Institute
Seoul, Korea, Republic of, 121-270
Sponsors and Collaborators
Earlogic Korea, Inc.
Investigators
Principal Investigator: Eunyee Kwak, Ph.D. Earlogic Auditory Research Institute
  More Information

No publications provided

Responsible Party: Earlogic Korea, Inc.
ClinicalTrials.gov Identifier: NCT01434446     History of Changes
Other Study ID Numbers: IEK 08252011
Study First Received: September 9, 2011
Last Updated: April 2, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hearing Loss
Deafness
Hearing Loss, Sensorineural
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on October 19, 2014