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This study is to see if applying red low-level laser light can help to reduce tinnitus symptoms
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Erchonia HLS | Experimental | 635 nanometers (nm) laser application |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Erchonia HLS | Device | 56 procedure administrations with the Erchonia® HLS™ administered by the subject at home: daily procedure administrations for 8 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline and 8 week |
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Inclusion Criteria:
Exclusion Criteria:
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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kathy Amos | Walnut Creek | California | 94598 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Posted | Mean | Standard Deviation | score on a scale | Baseline and 8 week |
|
8 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Travis Sammons | Erchonia Corporation | 3214731251 | tsammons@erchonia.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Mar 4, 2021 | Jul 12, 2023 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D014012 | Tinnitus |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
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| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
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.
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|
| 0 |
| 4 |
| 0 |
| 4 |
| 0 |
| 4 |
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| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |