The Effect of Sound Stimulation on Pure-tone Hearing Threshold

Status Completed

Clinical Trial Summary

The purpose of this study is to investigate if sound stimulation could improve pure-tone hearing threshold.

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.

Based on the results of animal studies, the investigators conducted a human study in 2007 and observed that sound stimulation could improve hearing ability. On average, the pure-tone hearing threshold decreased by 8.91 dB after sound stimulation for 2 weeks. In that study, however, the investigators observed only the hearing threshold changes by sound stimulation.

To verify the previous ameliorative effect of sound stimulation, the investigators included a control period in this study.

Clinical Trial Description

n/a

Study Design

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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01184248
Study type	Interventional
Source	Earlogic Korea, Inc.
Contact
Status	Completed
Phase	N/A
Start date	May 2010
Completion date	January 2011

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT00023036` - Clinical and Genetic Analysis of Enlarged Vestibular Aqueducts
Completed	`NCT03746613` - Clinal Evaluation of Navigation Based Functional Ear Surgery Using Image Guided and Robotically Assisted Techniques	N/A
Recruiting	`NCT05568329` - Appreciation for Music Processed by Hearing Aids	N/A
Withdrawn	`NCT05061758` - A Trial of LY3056480 in Patients With SNLH	Phase 2
Completed	`NCT01434446` - The Effect of Sound Stimulation on Hearing Ability	N/A
Completed	`NCT03212924` - Listening Effort in Cochlear Implant Users	N/A
Recruiting	`NCT06053190` - Effects of Clear Speech on Listening Effort and Memory in Sentence Processing	N/A
Completed	`NCT03718975` - Quality Control of CE-Certified Phonak Hearing Aids - 2018_28	N/A
Completed	`NCT06025097` - Intra-Tympanic Steroid With PRP Combination in Sensorineural Hearing Loss and Tinnitus.	Early Phase 1
Recruiting	`NCT04102215` - The Efficacy of a Minimally Invasive Direct Cochlear Access Via the HEARO Procedure	N/A
Recruiting	`NCT04108598` - The SeaSHeL National Prospective Cohort Study
Active, not recruiting	`NCT04750642` - Cochlear Implant With Dexamethasone Eluting Electrode Array	N/A
Completed	`NCT04120116` - FX-322 in Adults With Stable Sensorineural Hearing Loss	Phase 2
Recruiting	`NCT06223724` - Status Telemetry for Cochlear Implantations
Completed	`NCT02005822` - Congenital Cytomegalovirus: Efficacy of Antiviral Treatment	Phase 3
Suspended	`NCT02616172` - Autologous Bone Marrow Harvest and Transplant for Sensorineural Hearing Loss	Phase 1/Phase 2
Completed	`NCT02259595` - Study to Determine the Safety, Tolerability, and Pharmacokinetic Profile of HPN-07 and HPN-07 Plus NAC	Phase 1
Unknown status	`NCT01902914` - Effectiveness of P02 Digital Hearing Aids	Phase 1/Phase 2
Completed	`NCT00589511` - Nucleus Freedom Cochlear Implant System Pediatric Post-approval Study	N/A
Completed	`NCT03288753` - Comparison Between Neuro 1 and Neuro 2 Cochlear Implant Speech Processors	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.