NCT01434446

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

September 9, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 15, 2011

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

April 3, 2012

Status Verified

April 1, 2012

Enrollment Period

5 months

First QC Date

September 9, 2011

Last Update Submit

April 2, 2012

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

Listening to sound stimuli at the lowest audible level.

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female
  • Age between 20 and 70 years
  • Subjects should be able to use an mp3 player

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Earlogic Auditory Research Institute

Seoul, 121-270, South Korea

Location

MeSH Terms

Conditions

Hearing Loss, Sensorineural

Condition Hierarchy (Ancestors)

Hearing LossHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Eunyee Kwak, Ph.D.

    Earlogic Auditory Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2011

First Posted

September 15, 2011

Study Start

September 1, 2011

Primary Completion

February 1, 2012

Study Completion

April 1, 2012

Last Updated

April 3, 2012

Record last verified: 2012-04

Locations