TinnitusNCT00845975
Study of Low Level Laser Therapy and Tinnitus Relief
A study testing Erchonia Hearing Lasers #1 & #2 in people with Tinnitus, run by Erchonia Corporation at 1 site in United States.
Trial summary
The purpose of this study is to determine if low level laser light therapy might help to relieve tinnitus in adults. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tinnitus
- What is being tested?
- Erchonia Hearing Lasers #1 & #2
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to Nov 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
- Total score on the Tinnitus Handicap Inventory (THI) of at least 20.
- Tinnitus is on-going; present for more than 50% of the time over the past 6 months.
- Subject has been previously evaluated by a qualified health care professional for tinnitus and received a diagnosis of etiology of tinnitus related to hearing impairment and/or noise exposure and/or unknown.
- Any existing hearing loss stable over the past 12 months.
- Willingness to abstain from partaking in other, non-study procedures indicated to lessen tinnitus and/or its perception, with the exclusion of wearing hearing aids for those subjects who enter the study using hearing aids, throughout the course of study participation.
- Willing and able to refrain from engaging in activities or work involving loud noise exposure, such as hunting, rock concerts and work situations that involve working around loud machinery, construction sites, etc., throughout the course of study participation.
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- 18 years or older.
- Male or female.
- English as primary spoken language.
Who cannot join
- Presence of any of the following or in the subject's medical history:
- physical trauma or surgery to the head or neck
- uncontrolled hypertension
- current or prior surgically removed acoustic neuroma middle ear infection/active drainage from the ear and/or history of either within the previous 90 days
- impacted cerumen
- thyroid disease
Show all 37Show fewer
- vascular disorders
- Temporomandibular Joint Disorder (TMJD)
- nutritional deficiency
- aneurysm
- multiple sclerosis
- Episodic or infrequent tinnitus
- Somatic or pulsatile tinnitus
- Prior history of sudden hearing loss and/or fluctuating hearing levels .
- Consistent use of any of the following drugs within the past 30 days:
- NSAIDS; aspirin and other salicylates; Lasix and ther "loop"diuretics; "mycin" antibiotics such as vancomycin; quinine and related drugs; Chemotherapy agents such as cis-platin.
- Acute or chronic vertigo/dizziness.
- Prior diagnosis of central auditory processing disorder.
- Ménière's disease.
- Tympanic membrane perforation or tubes.
- Prior stapedectomy
- Prior mastoidectomy.
- Otosclerosis.
- Otosyphilis.
- Labyrinthitis.
- Auditory nerve damage.
- Stapedius myoclonus syndrome.
- Brain and/or brainstem injury.
- Cochlear implant.
- Photosensitivity disorder.
- Active/open infection, wound or other external trauma to the areas to be treated with the Hearing Laser.
- Pregnant or lactating.
- Serious mental health illness such as dementia or schizophrenia; psychiatric hospitalization in past two years.
- Developmental disability or cognitive impairment that would make it difficult for the subject to partake in the clinical study, including adequate comprehension of the informed consent form and ability to record the necessary measurements.
- History of drug or alcohol abuse.
- Involvement in litigation and/or a worker's compensation claim and/or receiving disability benefits related to tinnitus and/or hearing loss.
- Participation in research in the past 30 days.
Trial locations and contacts
1 site in 1 country.
United States1 site
McDonald Hearing Aid Center
Sacramento, California, 95825
About this study
Official title: A Double-blind, Placebo-controlled Randomized Evaluation of the Application of Low Level Laser Light Therapy Using the Erchonia Hearing Lasers for the Relief of Tinnitus Clinical Study Protocol.
The purpose of this study is to determine if low level laser light therapy might help to relieve tinnitus in adults.
Read the detailed description
Tinnitus is the perception of sound, such as a ringing or hissing, that occurs in the ears or head in the absence of external stimuli. About 40-50 million people in the United States report experiencing tinnitus; 10-12 million have sought medical help for their tinnitus, with 2.5 million reporting their tinnitus as debilitating. As a result of the distressing nature of tinnitus, it is often accompanied by anxiety, depression and sleep difficulties.
Tinnitus is most often caused by sensorineural hearing loss due to presbyacusis (aging) or noise damage. It is believed that the tinnitus results when spurious neuro-electrical signals are produced by diseased, degenerated or damaged cochlear hair cells and interpreted by the brain as tinnitus.
There is presently no cure for tinnitus. Current management strategies include using other external sounds to distract from the tinnitus, teaching relaxation and stress reduction techniques, and prescription medications to help ease stress, anxiety, depression and sleep difficulties. However, in general, current tinnitus management techniques are only minimally effective. It is believed that low level laser light therapy may offer a simple, non-invasive means of relieving the symptoms of tinnitus. In theory, low level laser light penetrates targeted tissues to stimulate the mitochondria in underlying cells to produce energy through the production of adenosine triphosphate (ATP). In turn, the enhanced ATP fuels cellular energy and enhances blood flow to the cochlear hair cells (cilia) to assists in regulating the electrical signals disrupted by the diseased and/or degenerated cochlear hair cells. With the taming of the spurious electrical signals, the brain no longer has a basis to perceive the noise known as tinnitus.
- Conditions
- Tinnitus
- Being tested
- Erchonia Hearing Lasers #1 & #2, Placebo Lasers
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erchonia Hearing Lasers #1 & #2Device
Two treatments with Erchonia Hearing Laser #1 administered by the investigator at the test site, each treatment seven days apart.
Seven treatments with the Erchonia Hearing Laser #2 administered by the subject at home, one time each day for seven consecutive days, the first administration on the same day as the first administration with the Erchonia Hearing Laser #1 at the test site.
Placebo LasersDevice
The same test site and at-home treatment administration protocols are followed, but the laser devices do not emit any therapeutic light.
| Study group | Role | What they receive |
|---|---|---|
| Erchonia Hearing Lasers #1 & #2 | Active comparator | Erchonia Hearing Laser #1 is a dual laser system composed of a pulsed red 7.5 milliwatts (mW) laser of 635 nm +/- 5 nm and a pulsed green 7.5 mW laser of 532 nm, both lasers in simultaneous operation when the laser is activated.
Erchonia Hearing Laser #2 is a single diode laser that in pulsed mode emits 4.9 mW of red 635 nm +/- 5 nm light. Receives: Device: Erchonia Hearing Lasers #1 & #2 |
| Placebo Lasers | Placebo comparator | Inactive lasers that do not emit any therapeutic light. Receives: Device: Placebo Lasers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Score on the Tinnitus Handicap Inventory (THI).
The Tinnitus Handicap Inventory (THI) is a 25-item questionnaire to assess how tinnitus affects an individual's life. Each question is responded to as 'yes' (4 points); 'sometimes' (2 points) or 'no' (0 points). The individual scores for the 25 questions are added to get a total THI score from 0 to 100. The higher the total THI score, the greater the negative impact tinnitus has on the individual's life. Change in total THI score is calculated as total THI score after the one week procedure administration phase minus total THI score at baseline. A positive (+) change in total THI score indicates the negative impact of tinnitus on the individual's everyday life has worsened. A negative (-) change indicates the negative impact of tinnitus on the individual's everyday life has improved (lessened). A change in total THI score of -20 or greater indicates a meaningful lessening of the impact of tinnitus on the individual's life and is positive for study success.
Measured: baseline and one week
Secondary outcomes (2)
Beck Depression Inventory-II (BDI-II)
The Beck Depression Inventory®-II (BDI®-II) is a 21-item questionnaire used to assess depression. Most items are rated on a 4-point scale from 0 to 3, and a few items are rated on a 7-point scale. Individual item scores are added to get a total score from 0 to 63. The higher the total score, the more severe the depression, and the lower the total score, the less severe the depression. Change in BDI®-II score is calculated as the BDI®-II score 4 weeks after baseline evaluation minus the BDI®-II score at baseline. A positive (+) change in BDI®-II score indicates that the depression has worsened. A negative (-) change in BDI®-II score indicates the depression has lessened. A change in BDI®-II score of -6 or greater indicates a meaningful lessening of depression and is positive for study success.
Measured: baseline and 4 weeks
Spielberger State-Trait Anxiety Inventory (STAI)- Trait Portion
The Trait portion of the State-Trait Anxiety Inventory (STAI-T) evaluates an individual's tendency to get anxious and how they respond to stress. The STAI-T has 20 items rated on a 4-point frequency of occurrence scale of 1=Almost Never, 2=Sometimes, 3=Moderately So, and 4=Very Much So. The individual scores are summed to get the total STAI-T score. The higher the total score, the more anxious the individual, and the lower the total score, the less anxious the individual. Change in STAI-T score is calculated as the STAI-T score at 4 weeks after baseline evaluation minus the STAI-T score at baseline. A positive (+) change in STAI-T score indicates that the anxiety has worsened. A negative (-) change in STAI-T score indicates the depression has lessened. A change in STAI-T score of -8 or greater indicates a meaningful lessening of anxiety and is positive for study success.
Measured: baseline and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2009 (estimated)
- Study startAug 2008
- Primary completionNov 2008
- Study completionNov 2008
Why it stopped: New information suggested a more effective treatment protocol.
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 TinnitusStudies 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
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erchonia Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Louis A Looper, MA, CCC-A, Principal investigator, McDonald Hearing Aid Centers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00845975
- Sponsor's protocol ID
- TS-001
- Status last verified
- May 2014
- First submitted
- 16 Feb 2009
- Last updated
- 5 Jun 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Placebo-controlled Randomized Evaluation of the Application of Low Level Laser Light Therapy Using the Erchonia Hearing Lasers for the Relief of Tinnitus Clinical Study Protocol.
- ClinicalTrials.gov ID
- NCT00845975
- Acronym / sponsor ID
- TS-001
- Conditions
- Tinnitus
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: New information suggested a more effective treatment protocol.
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Erchonia CorporationIndustry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 18 Feb 2009 (estimated)
- Results
- Posted 5 Jun 2014
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 determine if low level laser light therapy might help to relieve tinnitus in adults.
Detailed description
Tinnitus is the perception of sound, such as a ringing or hissing, that occurs in the ears or head in the absence of external stimuli. About 40-50 million people in the United States report experiencing tinnitus; 10-12 million have sought medical help for their tinnitus, with 2.5 million reporting their tinnitus as debilitating. As a result of the distressing nature of tinnitus, it is often accompanied by anxiety, depression and sleep difficulties.
Tinnitus is most often caused by sensorineural hearing loss due to presbyacusis (aging) or noise damage. It is believed that the tinnitus results when spurious neuro-electrical signals are produced by diseased, degenerated or damaged cochlear hair cells and interpreted by the brain as tinnitus.
There is presently no cure for tinnitus. Current management strategies include using other external sounds to distract from the tinnitus, teaching relaxation and stress reduction techniques, and prescription medications to help ease stress, anxiety, depression and sleep difficulties. However, in general, current tinnitus management techniques are only minimally effective. It is believed that low level laser light therapy may offer a simple, non-invasive means of relieving the symptoms of tinnitus. In theory, low level laser light penetrates targeted tissues to stimulate the mitochondria in underlying cells to produce energy through the production of adenosine triphosphate (ATP). In turn, the enhanced ATP fuels cellular energy and enhances blood flow to the cochlear hair cells (cilia) to assists in regulating the electrical signals disrupted by the diseased and/or degenerated cochlear hair cells. With the taming of the spurious electrical signals, the brain no longer has a basis to perceive the noise known as tinnitus.
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 |
|---|---|---|
| Erchonia Hearing Lasers #1 & #2 | Active comparator | Device: Erchonia Hearing Lasers #1 & #2Erchonia Hearing Laser #1 is a dual laser system composed of a pulsed red 7.5 milliwatts (mW) laser of 635 nm +/- 5 nm and a pulsed green 7.5 mW laser of 532 nm, both lasers in simultaneous operation when the laser is activated. Erchonia Hearing Laser #2 is a single diode laser that in pulsed mode emits 4.9 mW of red 635 nm +/- 5 nm light. |
| Placebo Lasers | Placebo comparator | Device: Placebo LasersInactive lasers that do not emit any therapeutic light. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Total score on the Tinnitus Handicap Inventory (THI) of at least 20.
- Tinnitus is on-going; present for more than 50% of the time over the past 6 months.
- Subject has been previously evaluated by a qualified health care professional for tinnitus and received a diagnosis of etiology of tinnitus related to hearing impairment and/or noise exposure and/or unknown.
- Any existing hearing loss stable over the past 12 months.
- Willingness to abstain from partaking in other, non-study procedures indicated to lessen tinnitus and/or its perception, with the exclusion of wearing hearing aids for those subjects who enter the study using hearing aids, throughout the course of study participation.
Key exclusion criteria (37 listed)
- Presence of any of the following or in the subject's medical history:
- physical trauma or surgery to the head or neck
- uncontrolled hypertension
- current or prior surgically removed acoustic neuroma middle ear infection/active drainage from the ear and/or history of either within the previous 90 days
- impacted cerumen
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 |
|---|---|---|
| Erchonia Hearing Lasers #1 & #2Two treatments with Erchonia Hearing Laser #1 administered by the investigator at the test site, each treatment seven days apart. Seven treatments with the Erchonia Hearing Laser #2 administered by the subject at home, one time each day for seven consecutive days, the first administration on the same day as the first administration with the Erchonia Hearing Laser #1 at the test site. | Device | Erchonia Hearing Lasers #1 & #2 |
| Placebo LasersThe same test site and at-home treatment administration protocols are followed, but the laser devices do not emit any therapeutic light. | Device | Placebo Lasers |
Primary outcome
Total Score on the Tinnitus Handicap Inventory (THI).
Time frame: baseline and one week
The Tinnitus Handicap Inventory (THI) is a 25-item questionnaire to assess how tinnitus affects an individual's life. Each question is responded to as 'yes' (4 points); 'sometimes' (2 points) or 'no' (0 points). The individual scores for the 25 questions are added to get a total THI score from 0 to 100. The higher the total THI score, the greater the negative impact tinnitus has on the individual's life. Change in total THI score is calculated as total THI score after the one week procedure administration phase minus total THI score at baseline. A positive (+) change in total THI score indicates the negative impact of tinnitus on the individual's everyday life has worsened. A negative (-) change indicates the negative impact of tinnitus on the individual's everyday life has improved (lessened). A change in total THI score of -20 or greater indicates a meaningful lessening of the impact of tinnitus on the individual's life and is positive for study success.
2 secondary outcomes
Beck Depression Inventory-II (BDI-II)
Time frame: baseline and 4 weeks
Spielberger State-Trait Anxiety Inventory (STAI)- Trait Portion
Time frame: baseline and 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2014.
- 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.
Louis A Looper, MA, CCC-A principal investigator
McDonald Hearing Aid Centers
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Erchonia Hearing Lasers #1 & #2 in people with Tinnitus, 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 9 inclusion and 37 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: stopped early, as of the sponsor's last update on 5 Jun 2014. 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 5 Jun 2014). 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?
Total Score on the Tinnitus Handicap Inventory (THI). (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 5 Jun 2014.