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Completed

NCT Number: NCT01434446

The Effect of Sound Stimulation on Hearing Ability

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.

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Key information

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Earlogic Auditory Research Institute

Seoul, 121-270, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sound stimulation

Behavioral

Listening to sound stimuli at the lowest audible level.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Earlogic Korea, Inc.

Industry

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Sep 15, 2011
Registry last updated
Apr 3, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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