Hearing LossNCT01820416
The Effect of Low-Level Laser Stimulation on Hearing Thresholds
A study testing Low-level Laser Therapy in people with Hearing Loss, run by University of Iowa at 1 site in United States.
Trial summary
The purpose of this study is to determine whether low-level laser therapy can improve hearing thresholds in individuals with hearing loss. Subjects will be randomly assigned to a treatment, placebo, or control group. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hearing Loss
- What is being tested?
- Low-level Laser Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Dec 2009
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- bilateral sensorineural hearing loss
- normal middle ear status
Who cannot join
- pregnant or lactating
- serious mental health illness or medical/psychiatric hospitalization
- treatment with cancer chemotherapeutic agents or aminoglycoside antibiotics
- taking Aspirin, Ibuprofen, Naprosyn, Aleve
- taking any Quinine-related drugs
- taking any loop diuretics
Show all 12Show fewer
- have a developmental disability or cognitive impairment
- history of drug abuse
- involved in litigation or claim related to hearing loss
- regularly exposed to significant occupational or recreational noise
- have a photosensitivity disorder
- have a retinal disease
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine whether low-level laser therapy can improve hearing thresholds in individuals with hearing loss. Subjects will be randomly assigned to a treatment, placebo, or control group. The treatment group will be given a three treatment of low-level laser therapy, which consists of shining low-level lasers beams onto the ear and head. The laser beams are cool to the touch, and do not cause discomfort. Each laser treatment will last approximately 4 minutes. Three treatments will be applied three times within the course of one week. Hearing tests will be administered immediately before treatment, immediately after treatment, and six weeks after treatment. Results will be analyzed to determine the effect of the laser treatment on hearing.
Read the detailed description
Low-level laser therapy has been practiced for about 20 years in Europe and is beginning to be practiced in the US. Theoretically, laser energy in the red and near infrared light spectrum is capable of penetrating 2-5 cm into tissue and can stimulate mitochondria in the cells to produce more energy (through the production of adenosine triphosphate), which in turn may help prevent or repair tissue damage. The effects of low-level laser therapy on hearing have not been well studied. It has been suggested that laser therapy might help repair damage to the cochlea and restore some degree of hearing loss. Studies of low-level laser stimulation of cochleae utilizing microscopy, PET imaging, and MRI suggest potential therapeutic benefit to hearing. While preliminary studies suggest a possible improvement in hearing thresholds, a carefully controlled study is needed to verify the results using a valid battery of audiological tests.
- Conditions
- Hearing Loss
- Being tested
- Low-level Laser Therapy, Placebo Comparator: Disabled Laser
- Keywords
- Hearing Loss, Bilateral, Hearing Loss, Sensorineural
- Medical subject headings
- Hearing Loss, Hearing Loss, Bilateral, Hearing Loss, Sensorineural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-level Laser TherapyRadiation
Also called Erchonia EHL laser (Erchonia Medical, Inc.)
Portable unit containing two laser diodes producing 532 and 635 nm wavelengths. Both diodes produced energy levels of 7.5 mw (class IIIb). Beams from both diodes were dispersed through lenses to create parallel line-generated beams, rather than spots. The 532 nm light was constant, and the 635 nm light was pulsed, with frequencies of 15 and 33 Hz. The pulsing alternated between frequencies every 30 seconds.
Placebo Comparator: Disabled LaserOther
Portable unit containing two DISABLED laser diodes. Same protocol was followed as for the Experimental (radiation) group, except that the disabled diodes produced no radiation.
| Study group | Role | What they receive |
|---|---|---|
| Low-Level Laser Therapy | Experimental | Low-level laser applied for approximately 4 minutes to the area around the pinna, the back of the neck, and the top of the head. Receives: Radiation: Low-level Laser Therapy |
| Disabled Laser | Placebo comparator | Low-level laser device with laser diodes disabled. Also applied for approximately 4 minutes to the area around the pinna, the back of the neck, and the top of the head. Receives: Other: Placebo Comparator: Disabled Laser |
| Control | No intervention | Visit laboratory using same schedule as experiment and placebo. No Low-level laser or any treatment applied. Used to assess normal test-retest variability. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Speech Perception
Hearing status, as assessed by the Connected Sentence Test (CST). Difference scores (post-test - pretest) are reported. The CST approximates everyday conversation. Scoring is based on the number of correctly repeated key words. Higher numbers indicate better scores. The minimum score is 0 (0%) and the maximum is 100 (100%). When comparing test-retest scores for an individual, Cox et al. (1988) suggest that changes of 15% or more (based on 100 key words) are indicative of significant changes. We subtracted the post-test from the pre-test, so that negative difference scores indicate worse performance, and positive difference scores indicate better performance. Difference scores with an absolute value smaller than 15 are interpreted as no significant change. In addition, pre- and post-test performance was assessed for groups using t-tests on the difference scores.
Measured: 7-10 days after baseline measures recorded
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2013 (estimated)
- Study startSep 2009
- Primary completionDec 2009
- Study completionDec 2009
Why it stopped: Analysis showed no clinically or statistically significant effects
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- More trials run by University of IowaThe sponsor's other registered studies.
- 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
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Collaborators
- GN Resound
- Responsible party
- Principal investigator, Shawn Goodman, University of Iowa
- Investigators
- Shawn S Goodman, PhD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01820416
- Sponsor's protocol ID
- 200808718
- Status last verified
- Apr 2017
- First submitted
- 25 Mar 2013
- Last updated
- 1 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Goodman SS, Bentler RA, Dittberner A, Mertes IB. The effect of low-level laser therapy on hearing. ISRN Otolaryngol. 2013 Apr 23;2013:916370. doi: 10.1155/2013/916370. eCollection 2013.
PubMed 24024040
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Low-Level Laser Stimulation on Hearing Thresholds
- ClinicalTrials.gov ID
- NCT01820416
- Acronym / sponsor ID
- 200808718
- Conditions
- Hearing Loss
- Keywords
- Hearing Loss, Bilateral, Hearing Loss, Sensorineural
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Analysis showed no clinically or statistically significant effects
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Collaborators
- GN Resound
- Study start
- Sep 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 28 Mar 2013 (estimated)
- Results
- Posted 1 Jun 2017
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 whether low-level laser therapy can improve hearing thresholds in individuals with hearing loss. Subjects will be randomly assigned to a treatment, placebo, or control group. The treatment group will be given a three treatment of low-level laser therapy, which consists of shining low-level lasers beams onto the ear and head. The laser beams are cool to the touch, and do not cause discomfort. Each laser treatment will last approximately 4 minutes. Three treatments will be applied three times within the course of one week. Hearing tests will be administered immediately before treatment, immediately after treatment, and six weeks after treatment. Results will be analyzed to determine the effect of the laser treatment on hearing.
Detailed description
Low-level laser therapy has been practiced for about 20 years in Europe and is beginning to be practiced in the US. Theoretically, laser energy in the red and near infrared light spectrum is capable of penetrating 2-5 cm into tissue and can stimulate mitochondria in the cells to produce more energy (through the production of adenosine triphosphate), which in turn may help prevent or repair tissue damage. The effects of low-level laser therapy on hearing have not been well studied. It has been suggested that laser therapy might help repair damage to the cochlea and restore some degree of hearing loss. Studies of low-level laser stimulation of cochleae utilizing microscopy, PET imaging, and MRI suggest potential therapeutic benefit to hearing. While preliminary studies suggest a possible improvement in hearing thresholds, a carefully controlled study is needed to verify the results using a valid battery of audiological tests.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low-Level Laser Therapy | Experimental | Radiation: Low-level Laser TherapyLow-level laser applied for approximately 4 minutes to the area around the pinna, the back of the neck, and the top of the head. |
| Disabled Laser | Placebo comparator | Other: Placebo Comparator: Disabled LaserLow-level laser device with laser diodes disabled. Also applied for approximately 4 minutes to the area around the pinna, the back of the neck, and the top of the head. |
| Control | No intervention | –Visit laboratory using same schedule as experiment and placebo. No Low-level laser or any treatment applied. Used to assess normal test-retest variability. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- bilateral sensorineural hearing loss
- normal middle ear status
Key exclusion criteria (12 listed)
- pregnant or lactating
- serious mental health illness or medical/psychiatric hospitalization
- treatment with cancer chemotherapeutic agents or aminoglycoside antibiotics
- taking Aspirin, Ibuprofen, Naprosyn, Aleve
- taking any Quinine-related drugs
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 |
|---|---|---|
| Low-level Laser TherapyAlso: Erchonia EHL laser (Erchonia Medical, Inc.)Portable unit containing two laser diodes producing 532 and 635 nm wavelengths. Both diodes produced energy levels of 7.5 mw (class IIIb). Beams from both diodes were dispersed through lenses to create parallel line-generated beams, rather than spots. The 532 nm light was constant, and the 635 nm light was pulsed, with frequencies of 15 and 33 Hz. The pulsing alternated between frequencies every 30 seconds. | Radiation | Low-Level Laser Therapy |
| Placebo Comparator: Disabled LaserPortable unit containing two DISABLED laser diodes. Same protocol was followed as for the Experimental (radiation) group, except that the disabled diodes produced no radiation. | Other | Disabled Laser |
Primary outcome
Change in Speech Perception
Time frame: 7-10 days after baseline measures recorded
Hearing status, as assessed by the Connected Sentence Test (CST). Difference scores (post-test - pretest) are reported. The CST approximates everyday conversation. Scoring is based on the number of correctly repeated key words. Higher numbers indicate better scores. The minimum score is 0 (0%) and the maximum is 100 (100%). When comparing test-retest scores for an individual, Cox et al. (1988) suggest that changes of 15% or more (based on 100 key words) are indicative of significant changes. We subtracted the post-test from the pre-test, so that negative difference scores indicate worse performance, and positive difference scores indicate better performance. Difference scores with an absolute value smaller than 15 are interpreted as no significant change. In addition, pre- and post-test performance was assessed for groups using t-tests on the difference scores.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24024040Goodman SS, Bentler RA, Dittberner A, Mertes IB. The effect of low-level laser therapy on hearing. ISRN Otolaryngol. 2013 Apr 23;2013:916370. doi: 10.1155/2013/916370. eCollection 2013.
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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.
Shawn S Goodman, PhD principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-level Laser Therapy in people with Hearing Loss, run by University of Iowa 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 2 inclusion and 12 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 1 Jun 2017. 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 1 Jun 2017). 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?
Change in Speech Perception (time frame: 7-10 days after baseline measures recorded). 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 NCT01820416, which also lists 1 linked publication.
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 1 Jun 2017; AzTrials last refreshed its copy on 4 Nov 2026.