Tinnitus
Conditions
Brief 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.
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.
Interventions
DEVICEErchonia® 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.
DEVICEPlacebo Laser
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.
Sponsors
Erchonia Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 * 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)
Exclusion criteria
* Tympanosclerosis * Meniere's disease * Acoustic neuromas * Current and consistent use of ototoxic medications * Presbycusis * Thyroid disease * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline to Study Endpoint in the Tinnitus Functional Index (TFI) | 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). |
Countries
United States
Participant flow
Pre-assignment details
The study procedure started with attainment of subject consent followed by subject randomization into a procedure group. Succeeding procedure group assignment the investigator performed the study qualification evaluation to determine if the subject was eligible. The Protocol enrollment number includes all subjects that signed the consent form, while the number of subjects that Started reflects the total number of subjects that satisfied the qualification criteria
Participants by arm
| Arm | Count |
|---|---|
| Erchonia® THL™ The Erchonia® EVRL™ is made up of (2) 405-nanometer violet laser diodes mounted in a portable handheld device.
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. | 8 |
| Placebo Laser The Placebo Laser has the same appearance as the Erchonia® THL™ but does not emit any therapeutic light.
Placebo Laser: 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. | 7 |
| Total | 15 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 3 | 4 |
Baseline characteristics
| Characteristic | Placebo Laser | Total | Erchonia® THL™ |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 5 Participants | 11 Participants | 6 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 4 Participants | 2 Participants |
| Age, Continuous | 55.6 years STANDARD_DEVIATION 12.25 | 64.8 years STANDARD_DEVIATION 12.27 | 70.4 years STANDARD_DEVIATION 8.33 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 7 Participants | 15 Participants | 8 Participants |
| Region of Enrollment United States | 7 participants | 15 participants | 8 participants |
| Sex: Female, Male Female | 5 Participants | 11 Participants | 6 Participants |
| Sex: Female, Male Male | 2 Participants | 4 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 7 |
| other Total, other adverse events | 0 / 8 | 0 / 7 |
| serious Total, serious adverse events | 0 / 8 | 0 / 7 |
Outcome results
Primary
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).
Time frame: Baseline and 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Erchonia® THL™ | Mean Change From Baseline to Study Endpoint in the Tinnitus Functional Index (TFI) | -8.96 score on a scale | Standard Deviation 15.53 |
| Placebo Laser | Mean Change From Baseline to Study Endpoint in the Tinnitus Functional Index (TFI) | -2.8 score on a scale | Standard Deviation 5.7 |