The Effect of Sound Stimulation on Hearing Ability

Sensorineural Hearing Loss Clinical Trial

Official title:

The Effect of Sound Stimulation on Hearing Ability

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01434446
• Other study ID #: IEK 08252011
• Status: Completed
• Phase: N/A
• First received: September 9, 2011
• Last updated: April 2, 2012
• Start date: September 2011
• Est. completion date: April 2012

Study information

• Verified date: April 2012
• Source: Earlogic Korea, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: April 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hearing Loss
• Hearing Loss, Sensorineural
• Sensorineural Hearing Loss

Intervention

Behavioral:
• Sound stimulation
Listening to sound stimuli at the lowest audible level.

Locations

Country	Name	City	State
Korea, Republic of	Earlogic Auditory Research Institute	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Earlogic Korea, Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of pure-tone hearing thresholds after sound stimulation	Pure-tone hearing thresholds of the baseline and the final point (after 2~6 months)will be compared.	2~6 months	No