History of Changes for Study: NCT05091060

A Pilot Evaluation of the Effect of the Erchonia® HLS™ for the Relief of Tinnitus Symptoms

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Study Record Versions

Version	Submitted Date	Changes
1	October 12, 2021	None (earliest Version on record)
2	November 15, 2021	Study Status and Study Identification
3	March 14, 2022	Recruitment Status, Study Status and Study Design
4	May 10, 2022	Study Status
5	July 12, 2023	Recruitment Status, Study Status, Document Section and Results
6	August 17, 2023	Study Status, Outcome Measures and Study Design

Comparison Format:

Merged
Side-by-Side

Study Identification


Unique Protocol ID:	R-Tinnitus-Pilot
Brief Title:	A Pilot Evaluation of the Effect of the Erchonia® HLS™ for the Relief of Tinnitus Symptoms
Official Title:	A Pilot Evaluation of the Effect of the Erchonia® HLS™ for the Relief of Tinnitus Symptoms
Secondary IDs:

Study Status


Record Verification:	October 2021
Overall Status:	Active, not recruiting
Study Start:	June 10, 2021
Primary Completion:	January 30, 2022 [Anticipated]
Study Completion:	June 30, 2022 [Anticipated]

First Submitted:	October 12, 2021
First Submitted that Met QC Criteria:	October 12, 2021
First Posted:	October 25, 2021 [Actual]

Last Update Submitted that Met QC Criteria:	October 12, 2021
Last Update Posted:	October 25, 2021 [Actual]

Sponsor/Collaborators


Sponsor:	Erchonia Corporation
Responsible Party:	Sponsor
Collaborators:

Oversight


U.S. FDA-regulated Drug:	No
U.S. FDA-regulated Device:	Yes
Unapproved/Uncleared Device:	Yes
Pediatric Postmarket Surveillance:
Data Monitoring:	No

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.

Conditions


Conditions:	Tinnitus
Keywords:

Study Design


Study Type:	Interventional
Primary Purpose:	Treatment
Study Phase:	Not Applicable
Interventional Study Model:	Single Group Assignment
Number of Arms:	1
Masking:	None (Open Label)
Allocation:	N/A
Enrollment:	5 [Anticipated]

Arms and Interventions

Arms	Assigned Interventions
Experimental: Erchonia HLS 635 nanometers (nm) laser application	Device: Erchonia HLS 56 procedure administrations with the Erchonia® HLS™ administered by the subject at home: daily procedure administrations for 8 weeks.

Outcome Measures

Primary Outcome Measures:

Total Score on the Tinnitus Handicap Inventory (THI).
[ Time Frame: Baseline and 8 week ]

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 one 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).

Eligibility


Minimum Age:	18 Years
Maximum Age:
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	No
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

Contacts/Locations


Locations:	United States, California
	Kathy Amos Walnut Creek, California, United States, 94598

IPDSharing


Plan to Share IPD:	No

References


Citations:
Links:
Available IPD/Information: