TinnitusNCT05374421
Efficacy of the Erchonia Corporation THL™ for Providing Relief of Tinnitus Symptoms
A study testing Erchonia® THL™ in people with Tinnitus, run by Erchonia Corporation at 1 site in United States.
Trial summary
The purpose of this clinical study is to determine the effectiveness of the Erchonia® THL™, manufactured by Erchonia Corporation (the Company), for prescription home use in providing relief of tinnitus symptoms when used by individuals in their own homes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tinnitus
- What is being tested?
- Erchonia® THL™
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 10 May 2022to 9 Dec 2022
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Bilateral tinnitus
- Current diagnosis of subjective tinnitus
- No hearing loss or sensorineural hearing loss only
- 18 years of age or older
- Able to read and write English
- Constant tinnitus on-going over at least the past 6 months
Show all 9Show fewer
- Willing to abstain from other tinnitus-related treatments, except existing hearing aid use, throughout the study duration.
- Tinnitus Functional Index (TFI) total score of 32 to 72 (Moderate to Big Problem)
- Degree of hearing loss is less than 60 dB (Moderate or less)
Who cannot join
- Tympanosclerosis
- Meniere's disease
- Acoustic neuromas
- Current and consistent use of ototoxic medications
- Presbycusis
- Thyroid disease
Show all 16Show fewer
- Skull fracture
- Traumatic brain injury (TBI)
- Depression
- Syphilis
- Retrocochlear tumors
- Conductive hearing loss
- Pregnant, think they might be pregnant, or breastfeeding.
- Open wounds (sores, cuts, ulcers, etc) around ears or neck
- Cancerous growths around ears or neck
- Difficulty with hand dexterity sufficient to impact the ability to administer treatments with the laser such as from severe arthritis in the hands, Multiple Sclerosis, -Cerebral Palsy, Parkinson's Disease, Huntington's Disease, etc.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Efficacy and Human Factors Validation Testing for Prescription Home Use of the Erchonia Corporation THL™ for Providing Relief of Tinnitus Symptoms
The purpose of this clinical study is to determine the effectiveness of the Erchonia® THL™, manufactured by Erchonia Corporation (the Company), for prescription home use in providing relief of tinnitus symptoms when used by individuals in their own homes.
Read the detailed description
Human Factors Validation Testing will initially be conducted to valuate a lay person's ability to understand and apply as applicable the information contained in the THL™ Use Device Proper Use Reference Guide, and device packaging and labeling materials to correctly, safely, and successfully activate and operate the THL™ to administer the treatment; and to identify any and all use difficulties, problems and errors, including those pertaining to critical tasks and close calls demonstrated by the lay person during device operation, and to subsequently mitigate each identified instance of use error through device and/or materials modification, and to subsequently evaluate the effectiveness of each modification, as applicable
Phase Two will commence following the successful completion of Phase One. Phase Two comprises the performance of a double-blind, randomized, placebo-controlled, clinical study of the efficacy of the Erchonia® THL™, manufactured by Erchonia Corporation (the Sponsor), for prescription home use application in providing relief of tinnitus symptoms when used by individuals in their own homes.
- Conditions
- Tinnitus
- Being tested
- Erchonia® THL™, Placebo Laser
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erchonia® THL™Device
The Erchonia® THL™ is made up of (2) 405-nanometer violet laser diodes mounted in a portable handheld device. The diodes are positioned approximately 4 inches from the skin and applied in a continuous back and forth sweeping motion from the top of the ear down the side of the neck. The treatments will be self-administered by the subject at his or her's place of residence, once per day for 28 days. Each procedure administration lasts 5 minutes per ear, for a total of 10 minutes.
Placebo LaserDevice
The Placebo Laser has the same appearance as the Erchonia® THL™ but does not emit any therapeutic light. The diodes are positioned approximately 4 inches from the skin and applied in a continuous back and forth sweeping motion from the top of the ear down the side of the neck. The treatments will be self-administered by the subject at his or her's place of residence, once per day for 28 days. Each procedure administration lasts 5 minutes per ear, for a total of 10 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Erchonia® THL™ | Active comparator | The Erchonia® EVRL™ is made up of (2) 405-nanometer violet laser diodes mounted in a portable handheld device. Receives: Device: Erchonia® THL™ |
| Placebo Laser | Placebo comparator | The Placebo Laser has the same appearance as the Erchonia® THL™ but does not emit any therapeutic light. Receives: Device: Placebo Laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change From Baseline to Study Endpoint in the Tinnitus Functional Index (TFI)
The Tinnitus Functional Index (TFI) has been highly recommended to be used in both clinical and research settings for tinnitus measurement (Meikle et al., 2011). The self-report questionnaire, consists of 25 items with a response option on an 11-point Likert scale from 0-10. The calculation of overall TFI score is as follows: (1) Sum all valid answers. (2) Divide by the number of questions for which the sum of the valid answers was based to yield the respondent's mean item score. (3) Multiply by 10 to attain the respondent's overall TFI score (0-100 range). Total TFI score can be categorized as Level of Tinnitus Severity as follows: 0 to 17: Not a problem,18 to 31: Small problem, 32 to 53: Moderate problem, 54 to 72: Big Problem, 73 to 100: Very big problem.
A negative (-) change indicates the negative impact of tinnitus on the individual's everyday life has improved (lessened).
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 posted16 May 2022
- Study start10 May 2022
- Primary completion9 Dec 2022
- Study completion9 Dec 2022
Why it stopped: Sponsor decision
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erchonia Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Steven Shanks, Study director, Erchonia Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05374421
- Sponsor's protocol ID
- R-EAR-HOME
- Status last verified
- Mar 2024
- First submitted
- 10 May 2022
- Last updated
- 12 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy and Human Factors Validation Testing for Prescription Home Use of the Erchonia Corporation THL™ for Providing Relief of Tinnitus Symptoms
- ClinicalTrials.gov ID
- NCT05374421
- Acronym / sponsor ID
- R-EAR-HOME
- Conditions
- Tinnitus
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Erchonia CorporationIndustry (pharma, biotech, devices)
- Study start
- 10 May 2022 (actual)
- Primary completion
- 9 Dec 2022 (actual)
- Study completion
- 9 Dec 2022 (actual)
- First posted
- 16 May 2022 (actual)
- Results
- Posted 12 Mar 2024
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 the Erchonia® THL™, manufactured by Erchonia Corporation (the Company), for prescription home use in providing relief of tinnitus symptoms when used by individuals in their own homes.
Detailed description
Human Factors Validation Testing will initially be conducted to valuate a lay person's ability to understand and apply as applicable the information contained in the THL™ Use Device Proper Use Reference Guide, and device packaging and labeling materials to correctly, safely, and successfully activate and operate the THL™ to administer the treatment; and to identify any and all use difficulties, problems and errors, including those pertaining to critical tasks and close calls demonstrated by the lay person during device operation, and to subsequently mitigate each identified instance of use error through device and/or materials modification, and to subsequently evaluate the effectiveness of each modification, as applicable
Phase Two will commence following the successful completion of Phase One. Phase Two comprises the performance of a double-blind, randomized, placebo-controlled, clinical study of the efficacy of the Erchonia® THL™, manufactured by Erchonia Corporation (the Sponsor), for prescription home use application in providing relief of tinnitus symptoms when used by individuals in their own homes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Erchonia® THL™ | Active comparator | Device: Erchonia® THL™The Erchonia® EVRL™ is made up of (2) 405-nanometer violet laser diodes mounted in a portable handheld device. |
| Placebo Laser | Placebo comparator | Device: Placebo LaserThe Placebo Laser has the same appearance as the Erchonia® THL™ but does not emit any therapeutic light. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Bilateral tinnitus
- Current diagnosis of subjective tinnitus
- No hearing loss or sensorineural hearing loss only
- 18 years of age or older
- Able to read and write English
Key exclusion criteria (16 listed)
- Tympanosclerosis
- Meniere's disease
- Acoustic neuromas
- Current and consistent use of ototoxic medications
- Presbycusis
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® THL™The Erchonia® THL™ is made up of (2) 405-nanometer violet laser diodes mounted in a portable handheld device. The diodes are positioned approximately 4 inches from the skin and applied in a continuous back and forth sweeping motion from the top of the ear down the side of the neck. The treatments will be self-administered by the subject at his or her's place of residence, once per day for 28 days. Each procedure administration lasts 5 minutes per ear, for a total of 10 minutes. | Device | Erchonia® THL™ |
| Placebo LaserThe Placebo Laser has the same appearance as the Erchonia® THL™ but does not emit any therapeutic light. The diodes are positioned approximately 4 inches from the skin and applied in a continuous back and forth sweeping motion from the top of the ear down the side of the neck. The treatments will be self-administered by the subject at his or her's place of residence, once per day for 28 days. Each procedure administration lasts 5 minutes per ear, for a total of 10 minutes. | Device | Placebo Laser |
Primary outcome
Mean Change From Baseline to Study Endpoint in the Tinnitus Functional Index (TFI)
Time frame: Baseline and 4 weeks
The Tinnitus Functional Index (TFI) has been highly recommended to be used in both clinical and research settings for tinnitus measurement (Meikle et al., 2011). The self-report questionnaire, consists of 25 items with a response option on an 11-point Likert scale from 0-10. The calculation of overall TFI score is as follows: (1) Sum all valid answers. (2) Divide by the number of questions for which the sum of the valid answers was based to yield the respondent's mean item score. (3) Multiply by 10 to attain the respondent's overall TFI score (0-100 range). Total TFI score can be categorized as Level of Tinnitus Severity as follows: 0 to 17: Not a problem,18 to 31: Small problem, 32 to 53: Moderate problem, 54 to 72: Big Problem, 73 to 100: Very big problem. A negative (-) change indicates the negative impact of tinnitus on the individual's everyday life has improved (lessened).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Steven Shanks study director
Erchonia Corporation
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® THL™ 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 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: stopped early, as of the sponsor's last update on 12 Mar 2024. 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 12 Mar 2024). 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?
Mean Change From Baseline to Study Endpoint in the Tinnitus Functional Index (TFI) (time frame: Baseline and 4 weeks). 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 12 Mar 2024.