The Effect of Sound Stimulation on Hearing Ability

• Sponsor: Earlogic Korea, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01434446
• Collaborator: (none)
• Enrollment: 21
• Location: 1
• Duration (Months): 7
• Patients Per Site Per Month: 3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sensorineural Hearing Loss	Behavioral: Sound stimulation	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 21 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Effect of Sound Stimulation on Hearing Ability
• Study Start Date: Sep 1, 2011
• Actual Primary Completion Date: Feb 1, 2012
• Actual Study Completion Date: Apr 1, 2012

Outcome Measures

Primary Outcome Measures

1. Changes of pure-tone hearing thresholds after sound stimulation [2~6 months]

   Pure-tone hearing thresholds of the baseline and the final point (after 2~6 months)will be compared.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Earlogic Korea, Inc.
• ClinicalTrials.gov Identifier: NCT01434446
• Other Study ID Numbers: IEK 08252011
• First Posted: Sep 15, 2011
• Last Update Posted: Apr 3, 2012
• Last Verified: Apr 1, 2012

• Additional relevant MeSH terms: Hearing Loss; Hearing Loss, Sensorineural

Study Results

No Results Posted as of Apr 3, 2012