Sensorineural Hearing LossNCT00787189
Study of Low Level Laser Therapy and Word Recognition in Hearing Impaired Individuals
A study testing The Hearing Laser in people with Sensorineural Hearing Loss, run by Erchonia Corporation at 1 site in United States.
Trial summary
The purpose of this clinical study is to determine the effectiveness of low level laser light therapy when applied around the head and ears in improving unaided word recognition in ears with sensorineural hearing loss. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sensorineural Hearing Loss
- What is being tested?
- The Hearing Laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to Jun 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Sensorineural hearing loss.
- Mild or greater degree.
- Adult onset.
- Gradual onset.
- Hearing loss stable over past 12 months.
- Etiology of presbyacusis or noise-induced hearing loss.
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- Unaided word recognition score between 28% and 86%.
- English as primary spoken language.
- Willing and able to abstain from other treatments or medications to improve hearing ability.
- Willing and able to abstain from work or other activities that involve loud noise exposure.
Who cannot join
- Central auditory processing disorder.
- Active/recurrent middle ear infection.
- Meniere's disease.
- Tympanic membrane perforation/tubes.
- Cochlear implant.
- Removal of acoustic neuroma.
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- Hyperacusis/misphonia.
- Photosensitivity disorder.
- Active infection/wound in head/ear region.
- Pregnant/lactating.
- Serious mental health illness.
- Significant developmental disability/cognitive impairment.
- History of drug/alcohol abuse.
- Involvement in litigation/worker's compensation/disability benefits for hearing loss.
- Other research participation in past 90 days.
- Use of ototoxic medications known to cause temporary or permanent hearing loss.
Trial locations and contacts
1 site in 1 country.
United States1 site
McDonald Hearing Centers
Sacramento, California, 95818
About this study
Official title: The Effects of the Erchonia Hearing Laser on Word Recognition in Hearing Impaired Individuals Clinical Study Protocol
The purpose of this clinical study is to determine the effectiveness of low level laser light therapy when applied around the head and ears in improving unaided word recognition in ears with sensorineural hearing loss.
Read the detailed description
Sensorineural hearing loss accounts for about 90% of all hearing loss and is found in 23% of individuals older than 65 years. Sensorineural hearing loss occurs when the hair cells of the inner ear and the neural pathways to the auditory cortex are damaged. In most cases, sensorineural hearing loss cannot be improved, reversed or 'cured.' Current treatment options focus on methods that amplify external sounds and on teaching the patient various strategies to 'retrain' the brain to interpret external stimuli. Low Level Laser Therapy was first applied for the treatment of inner ear diseases by Uwe Witt, MD of Hamburg, Germany in the 1980's. Hearing impaired patients have inflammation and/or atrophy of the tissues and neural pathways connected to and supporting the cochlea's cilia hair structure, the hearing mechanism of the inner ear. Low level laser therapy is believed to stimulate the mitochondria of the adipocyte cells, which subsequently increases the production of ATP. The resultant surge in ATP production works to repair damaged tissue and regenerate cells reversing some of the damage incurred to the cochlea and thus improving aspects of hearing function.
- Conditions
- Sensorineural Hearing Loss
- Being tested
- The Hearing Laser, Placebo Laser
- Keywords
- sensorineural hearing loss, tinnitus, word recognition
- Medical subject headings
- Hearing Loss, Sensorineural, Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Hearing LaserDevice
Two 6-minute low level laser light applications to the head/neck/ears region, each one week apart.
Placebo LaserDevice
inactive low level laser light therapy with no therapeutic output
| Study group | Role | What they receive |
|---|---|---|
| The Hearing Laser | Active comparator | Active low level laser light therapy of 635 nanometers (nm) Receives: Device: The Hearing Laser |
| Placebo Laser | Placebo comparator | inactive low level laser light therapy with no therapeutic output Receives: Device: Placebo Laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants Whose Change in Percent Correct Word Recognition Scores From Baseline to One Week After Study Treatment Equalled or Exceeded the Minimum Change in a Reference Chart.
Participants were asked to repeat 50 words presented one at a time through headphones to each ear separately at a comfortable listening level to the participant. The 50 words were from a phonetically-balanced list of monosyllabic words called the Central Institute for the Deaf (CID) W-22 lists. For each ear, each word repeated correctly was scored '1'. The total number correct for each ear was summed and multiplied by 2 to attain the percent of total words repeated correctly for each ear. The change in this percent from baseline to one week after study treatment was referenced against a chart. If the change was equal to or greater than the corresponding value in the chart, the participant was considered to have a successful study outcome.
Measured: baseline and one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2008 (estimated)
- Study startAug 2007
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erchonia Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Betty McNamara, M.S., CCC-A, Principal investigator, Maryjane Rees Language Speech & Hearing Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00787189
- Sponsor's protocol ID
- EHL-001
- Status last verified
- May 2021
- First submitted
- 6 Nov 2008
- Last updated
- 28 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of the Erchonia Hearing Laser on Word Recognition in Hearing Impaired Individuals Clinical Study Protocol
- ClinicalTrials.gov ID
- NCT00787189
- Acronym / sponsor ID
- EHL-001
- Conditions
- Sensorineural Hearing Loss
- Keywords
- sensorineural hearing loss, tinnitus, word recognition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Erchonia CorporationIndustry (pharma, biotech, devices)
- Study start
- Aug 2007
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 7 Nov 2008 (estimated)
- Results
- Posted 11 Jul 2011
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 clinical study is to determine the effectiveness of low level laser light therapy when applied around the head and ears in improving unaided word recognition in ears with sensorineural hearing loss.
Detailed description
Sensorineural hearing loss accounts for about 90% of all hearing loss and is found in 23% of individuals older than 65 years. Sensorineural hearing loss occurs when the hair cells of the inner ear and the neural pathways to the auditory cortex are damaged. In most cases, sensorineural hearing loss cannot be improved, reversed or 'cured.' Current treatment options focus on methods that amplify external sounds and on teaching the patient various strategies to 'retrain' the brain to interpret external stimuli. Low Level Laser Therapy was first applied for the treatment of inner ear diseases by Uwe Witt, MD of Hamburg, Germany in the 1980's. Hearing impaired patients have inflammation and/or atrophy of the tissues and neural pathways connected to and supporting the cochlea's cilia hair structure, the hearing mechanism of the inner ear. Low level laser therapy is believed to stimulate the mitochondria of the adipocyte cells, which subsequently increases the production of ATP. The resultant surge in ATP production works to repair damaged tissue and regenerate cells reversing some of the damage incurred to the cochlea and thus improving aspects of hearing function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The Hearing Laser | Active comparator | Device: The Hearing LaserActive low level laser light therapy of 635 nanometers (nm) |
| Placebo Laser | Placebo comparator | Device: Placebo Laserinactive low level laser light therapy with no therapeutic output |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Sensorineural hearing loss.
- Mild or greater degree.
- Adult onset.
- Gradual onset.
- Hearing loss stable over past 12 months.
Key exclusion criteria (16 listed)
- Central auditory processing disorder.
- Active/recurrent middle ear infection.
- Meniere's disease.
- Tympanic membrane perforation/tubes.
- Cochlear implant.
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 |
|---|---|---|
| The Hearing LaserTwo 6-minute low level laser light applications to the head/neck/ears region, each one week apart. | Device | The Hearing Laser |
| Placebo Laserinactive low level laser light therapy with no therapeutic output | Device | Placebo Laser |
Primary outcome
Participants Whose Change in Percent Correct Word Recognition Scores From Baseline to One Week After Study Treatment Equalled or Exceeded the Minimum Change in a Reference Chart.
Time frame: baseline and one week
Participants were asked to repeat 50 words presented one at a time through headphones to each ear separately at a comfortable listening level to the participant. The 50 words were from a phonetically-balanced list of monosyllabic words called the Central Institute for the Deaf (CID) W-22 lists. For each ear, each word repeated correctly was scored '1'. The total number correct for each ear was summed and multiplied by 2 to attain the percent of total words repeated correctly for each ear. The change in this percent from baseline to one week after study treatment was referenced against a chart. If the change was equal to or greater than the corresponding value in the chart, the participant was considered to have a successful study outcome.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Betty McNamara, M.S., CCC-A principal investigator
Maryjane Rees Language Speech & Hearing Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Hearing Laser in people with Sensorineural Hearing Loss, run by Erchonia Corporation 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 10 inclusion and 16 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 28 May 2021. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 11 Jul 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Participants Whose Change in Percent Correct Word Recognition Scores From Baseline to One Week After Study Treatment Equalled or Exceeded the Minimum Change in a Reference Chart. (time frame: baseline and one week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 May 2021.