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

NCT ID: NCT05374421

Last Updated: 2024-03-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-10
• Study Completion Date: 2022-12-09

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.

Conditions

Tinnitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Erchonia® THL™

The Erchonia® EVRL™ is made up of (2) 405-nanometer violet laser diodes mounted in a portable handheld device.

Group Type: ACTIVE_COMPARATOR

Erchonia® THL™

Intervention Type: DEVICE

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.

Group Type: PLACEBO_COMPARATOR

Placebo Laser

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Erchonia Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Steven Shanks

Role: STUDY_DIRECTOR

Erchonia Corporation

Locations

Valley Audiology

Concord, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

R-EAR-HOME

Identifier Type: -

Identifier Source: org_study_id