Back to resultsEffect of the Erchonia® HLS™ for the Relief of Tinnitus Symptoms
Primary Purpose
Tinnitus
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Erchonia HLS
Sponsored by
About this trial
This is an interventional treatment trial for Tinnitus
Eligibility Criteria
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
Sites / Locations
- Kathy Amos
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Erchonia HLS
Arm Description
635 nanometers (nm) laser application
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05091060
Brief Title
Effect of the Erchonia® HLS™ for the Relief of Tinnitus Symptoms
Official Title
Erchonia and InnerScope, Pilot Evaluation of the Effect of the Erchonia® HLS™ for the Relief of Tinnitus Symptoms
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Terminated
Why Stopped
Sponsor decision
Study Start Date
June 10, 2021 (Actual)
Primary Completion Date
March 14, 2022 (Actual)
Study Completion Date
March 14, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Erchonia Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinnitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Erchonia HLS
Arm Type
Experimental
Arm Description
635 nanometers (nm) laser application
Intervention Type
Device
Intervention Name(s)
Erchonia HLS
Intervention Description
56 procedure administrations with the Erchonia® HLS™ administered by the subject at home: daily procedure administrations for 8 weeks.
Primary Outcome Measure Information:
Title
Total Score on the Tinnitus Handicap Inventory (THI).
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Kathy Amos
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Effect of the Erchonia® HLS™ for the Relief of Tinnitus Symptoms
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