Efficacy of the Erchonia Corporation THL™ for Providing Relief of Tinnitus Symptoms

Tinnitus Clinical Trial

Official title:

Clinical Efficacy and Human Factors Validation Testing for Prescription Home Use of the Erchonia Corporation THL™ for Providing Relief of Tinnitus Symptoms

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05374421
• Other study ID #: R-EAR-HOME
• Status: Terminated
• Phase: N/A
• Start date: May 10, 2022
• Est. completion date: December 9, 2022

Study information

• Verified date: March 2024
• Source: Erchonia Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 23
• Est. completion date: December 9, 2022
• Est. primary completion date: December 9, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Tinnitus

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Valley Audiology	Concord	California

Sponsors (1)

Lead Sponsor	Collaborator
Erchonia Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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).	Baseline and 4 weeks