Clinical trial NCT05374421: 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
Overall status: TERMINATED
Phase: NA
Conditions: Tinnitus
Lead sponsor: Erchonia Corporation
Sponsor class: INDUSTRY
First posted: 2022-05-16
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Mean Change From Baseline to Study Endpoint in the Tinnitus Functional Index (TFI)
timeFrame: Baseline and 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Concord
country: United States
facility: Valley Audiology
state: California
Study officials:
affiliation: Erchonia Corporation
name: Steven Shanks
role: STUDY_DIRECTOR
References: