Sensorineural Hearing LossNCT01184248
The Effect of Sound Stimulation on Pure-tone Hearing Threshold
A study testing Sound stimulation in people with Sensorineural Hearing Loss, run by Earlogic Korea, Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Sensorineural Hearing Loss
- What is being tested?
- Sound stimulation
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to Jan 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- You are a male or female aged between 18 and 70 years
- You have 25~70 dB HL hearing loss at any frequency above 1.5 kHz
- You are able to use an mp3 player
- You are able to read English
Who cannot join
- Under the medications that could cause hearing loss (such as gentamicin, aspirin, ibuprofen, or acetaminophen)
- Chronic disease that could affect hearing (such as diabetes or high blood pressure)
- Temporal hearing loss
- Hearing loss more than 75 dB HL at any frequency
- Ear infections, chronic middle ear disease or any abnormality of the ear canal or ear drum
- Hearing aid user
- Pregnant females
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Sensorineural Hearing Loss
- Being tested
- Sound stimulation
- Medical subject headings
- Hearing Loss, Sensorineural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sound stimulationBehavioural
Listening to sound stimuli at the lowest audible level.
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of pure-tone hearing thresholds after sound stimulation
Measured: 4-6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2010 (estimated)
- Study startMay 2010
- Primary completionDec 2010
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Sensorineural Hearing LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Earlogic Korea, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eunyee Kwak, Ph.D., Principal investigator, Earlogic Auditory Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01184248
- Sponsor's protocol ID
- IEK14152010
- Status last verified
- Sep 2011
- First submitted
- 16 Aug 2010
- Last updated
- 8 Sep 2011
- Results posted
- No
Publications
Canlon B, Borg E, Flock A. Protection against noise trauma by pre-exposure to a low level acoustic stimulus. Hear Res. 1988 Jul 15;34(2):197-200. doi: 10.1016/0378-5955(88)90107-4.
PubMed 3170362Miyakita T, Hellstrom PA, Frimanson E, Axelsson A. Effect of low level acoustic stimulation on temporary threshold shift in young humans. Hear Res. 1992 Jul;60(2):149-55. doi: 10.1016/0378-5955(92)90017-h.
PubMed 1639725Harris KC, Bielefeld E, Hu BH, Henderson D. Increased resistance to free radical damage induced by low-level sound conditioning. Hear Res. 2006 Mar;213(1-2):118-29. doi: 10.1016/j.heares.2005.11.012. Epub 2006 Feb 8.
PubMed 16466871Kujawa SG, Liberman MC. Long-term sound conditioning enhances cochlear sensitivity. J Neurophysiol. 1999 Aug;82(2):863-73. doi: 10.1152/jn.1999.82.2.863.
PubMed 10444683Niu X, Tahera Y, Canlon B. Protection against acoustic trauma by forward and backward sound conditioning. Audiol Neurootol. 2004 Sep-Oct;9(5):265-73. doi: 10.1159/000080226. Epub 2004 Aug 13.
PubMed 15316199Norena AJ, Eggermont JJ. Enriched acoustic environment after noise trauma reduces hearing loss and prevents cortical map reorganization. J Neurosci. 2005 Jan 19;25(3):699-705. doi: 10.1523/JNEUROSCI.2226-04.2005.
PubMed 15659607
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Sound Stimulation on Pure-tone Hearing Threshold
- ClinicalTrials.gov ID
- NCT01184248
- Acronym / sponsor ID
- IEK14152010
- Conditions
- Sensorineural Hearing Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Earlogic Korea, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 18 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- You are a male or female aged between 18 and 70 years
- You have 25~70 dB HL hearing loss at any frequency above 1.5 kHz
- You are able to use an mp3 player
- You are able to read English
Key exclusion criteria (7 listed)
- Under the medications that could cause hearing loss (such as gentamicin, aspirin, ibuprofen, or acetaminophen)
- Chronic disease that could affect hearing (such as diabetes or high blood pressure)
- Temporal hearing loss
- Hearing loss more than 75 dB HL at any frequency
- Ear infections, chronic middle ear disease or any abnormality of the ear canal or ear drum
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sound stimulationListening to sound stimuli at the lowest audible level. | Behavioural | – |
Primary outcome
Changes of pure-tone hearing thresholds after sound stimulation
Time frame: 4-6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2011.
- Background: PubMed 3170362Canlon B, Borg E, Flock A. Protection against noise trauma by pre-exposure to a low level acoustic stimulus. Hear Res. 1988 Jul 15;34(2):197-200. doi: 10.1016/0378-5955(88)90107-4.
- Background: PubMed 1639725Miyakita T, Hellstrom PA, Frimanson E, Axelsson A. Effect of low level acoustic stimulation on temporary threshold shift in young humans. Hear Res. 1992 Jul;60(2):149-55. doi: 10.1016/0378-5955(92)90017-h.
- Background: PubMed 16466871Harris KC, Bielefeld E, Hu BH, Henderson D. Increased resistance to free radical damage induced by low-level sound conditioning. Hear Res. 2006 Mar;213(1-2):118-29. doi: 10.1016/j.heares.2005.11.012. Epub 2006 Feb 8.
- Background: PubMed 10444683Kujawa SG, Liberman MC. Long-term sound conditioning enhances cochlear sensitivity. J Neurophysiol. 1999 Aug;82(2):863-73. doi: 10.1152/jn.1999.82.2.863.
- Background: PubMed 15316199Niu X, Tahera Y, Canlon B. Protection against acoustic trauma by forward and backward sound conditioning. Audiol Neurootol. 2004 Sep-Oct;9(5):265-73. doi: 10.1159/000080226. Epub 2004 Aug 13.
- Background: PubMed 15659607Norena AJ, Eggermont JJ. Enriched acoustic environment after noise trauma reduces hearing loss and prevents cortical map reorganization. J Neurosci. 2005 Jan 19;25(3):699-705. doi: 10.1523/JNEUROSCI.2226-04.2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eunyee Kwak, Ph.D. principal investigator
Earlogic Auditory Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sound stimulation in people with Sensorineural Hearing Loss, run by Earlogic Korea, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of pure-tone hearing thresholds after sound stimulation (time frame: 4-6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01184248, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2011.