Back to resultsEfficacy of the Erchonia Corporation THL™ for Providing Relief of Tinnitus Symptoms
Primary Purpose
Tinnitus
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Erchonia® THL™
Placebo Laser
Sponsored by
About this trial
This is an interventional treatment trial for Tinnitus
Eligibility Criteria
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.
Sites / Locations
- Valley Audiology
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Erchonia® THL™
Placebo Laser
Arm Description
The Erchonia® EVRL™ is made up of (2) 405-nanometer violet laser diodes mounted in a portable handheld device.
The Placebo Laser has the same appearance as the Erchonia® THL™ but does not emit any therapeutic light.
Outcomes
Primary Outcome Measures
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 due to its responsiveness to treatment-related change, validity for scaling the overall severity of tinnitus, and comprehensive coverage of multiple domains of tinnitus severity (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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05374421
Brief Title
Efficacy of the Erchonia Corporation THL™ for Providing Relief of Tinnitus Symptoms
Official Title
Clinical Efficacy and Human Factors Validation Testing for Prescription Home Use of the Erchonia Corporation THL™ for Providing Relief of Tinnitus Symptoms
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Terminated
Why Stopped
Sponsor decision
Study Start Date
May 10, 2022 (Actual)
Primary Completion Date
December 9, 2022 (Actual)
Study Completion Date
December 9, 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
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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.
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
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Erchonia® THL™
Arm Type
Active Comparator
Arm Description
The Erchonia® EVRL™ is made up of (2) 405-nanometer violet laser diodes mounted in a portable handheld device.
Arm Title
Placebo Laser
Arm Type
Placebo Comparator
Arm Description
The Placebo Laser has the same appearance as the Erchonia® THL™ but does not emit any therapeutic light.
Intervention Type
Device
Intervention Name(s)
Erchonia® THL™
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Placebo Laser
Intervention Description
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.
Primary Outcome Measure Information:
Title
Tinnitus Functional Index (TFI)
Description
The Tinnitus Functional Index (TFI) has been highly recommended to be used in both clinical and research settings for tinnitus measurement due to its responsiveness to treatment-related change, validity for scaling the overall severity of tinnitus, and comprehensive coverage of multiple domains of tinnitus severity (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
Time Frame
Basline and 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Valley Audiology
City
Concord
State/Province
California
ZIP/Postal Code
94520
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy of the Erchonia Corporation THL™ for Providing Relief of Tinnitus Symptoms
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