Tinnitus
Conditions
Brief summary
This study is to see if applying red low-level laser light can help to reduce tinnitus symptoms
Detailed description
The purpose of this pilot study is to determine the effectiveness of the Erchonia® HLS™, manufactured by Erchonia Corporation (the Company), in providing temporary relief of tinnitus symptoms in adults 18 years and older.
Interventions
DEVICEErchonia HLS
56 procedure administrations with the Erchonia® HLS™ administered by the subject at home: daily procedure administrations for 8 weeks.
Sponsors
Erchonia Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjective tinnitus * Tonal tinnitus. * Constant tinnitus on-going at least half the time over at least the past 6 months. * Willing to abstain from other tinnitus-related treatments except prior hearing aid use throughout the study duration. * Willing and able to refrain from activities or work involving excessive noise exposure without the use of effective hearing protection throughout study participation. * 18 years of age or older * Primary language is English
Exclusion criteria
* Objective tinnitus * Atonal, pulsatile, intermittent, or occasional tinnitus * Severe or profound hearing loss in one or both ears * Current or prior surgically removed acoustic neuroma * Consistent use of any of the following drugs known to cause or increase tinnitus (primarily ototoxins) within the past 30 days: NSAIDS (motrin, naproxen, relafen, etc) aspirin (exceeding 300mg per day) and other salicylates Lasix and other loop diuretics mycin antibiotics such as vancomycin quinine and related drugs Chemotherapy agents such as cis-platin * Acute or chronic vertigo/dizziness * Ménière's disease * Prior stapendectomy * Prior mastoidectomy * Auditory nerve tumor (acoustic neuroma), current or surgically removed in the past * Active infection/wound/external trauma to the areas to be treated with the laser * Medical, physical or other contraindications for, or sensitivity to, light therapy * Pregnant, breast feeding, or planning pregnancy prior to the end of study participation * Developmental disability or cognitive impairment that in the opinion of the investigator would preclude adequate comprehension of the informed consent form and/or ability to record the necessary study measurements
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Score on the Tinnitus Handicap Inventory (THI). | Baseline and 8 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 eight 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Erchonia HLS 635 nanometers (nm) laser application
Erchonia HLS: 56 procedure administrations with the Erchonia® HLS™ administered by the subject at home: daily procedure administrations for 8 weeks. | 5 |
| Total | 5 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | Erchonia HLS |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants |
| Age, Continuous | 58.25 years STANDARD_DEVIATION 4.65 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 5 Participants |
| Region of Enrollment United States | 5 participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 4 |
| other Total, other adverse events | 0 / 4 |
| serious Total, serious adverse events | 0 / 4 |
Outcome results
Primary
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 eight 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).
Time frame: Baseline and 8 week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Erchonia HLS | Total Score on the Tinnitus Handicap Inventory (THI). | -24 score on a scale | Standard Deviation 10.09 |