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Effect of the Erchonia® HLS™ for the Relief of Tinnitus Symptoms

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05091060
Recruitment Status : Terminated (Sponsor decision)
First Posted : October 25, 2021
Results First Posted : August 1, 2023
Last Update Posted : August 30, 2023
Sponsor:
Information provided by (Responsible Party):
Erchonia Corporation

Study Description
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Brief Summary:
This study is to see if applying red low-level laser light can help to reduce tinnitus symptoms

Condition or disease Intervention/treatment Phase
Tinnitus Device: Erchonia HLS Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Erchonia and InnerScope, Pilot Evaluation of the Effect of the Erchonia® HLS™ for the Relief of Tinnitus Symptoms
Actual Study Start Date : June 10, 2021
Actual Primary Completion Date : March 14, 2022
Actual Study Completion Date : March 14, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tinnitus

Arms and Interventions
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Arm Intervention/treatment
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
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Primary Outcome Measures :
  1. 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 eight 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 Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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 and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05091060


Locations
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United States, California
Kathy Amos
Walnut Creek, California, United States, 94598
Sponsors and Collaborators
Erchonia Corporation
  Study Documents (Full-Text)

Documents provided by Erchonia Corporation:
Study Protocol, Statistical Analysis Plan, and Informed Consent Form  [PDF] March 4, 2021

More Information
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Responsible Party: Erchonia Corporation
ClinicalTrials.gov Identifier: NCT05091060    
Other Study ID Numbers: R-Tinnitus-Pilot
First Posted: October 25, 2021    Key Record Dates
Results First Posted: August 1, 2023
Last Update Posted: August 30, 2023
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
 Sensation Disorders
Neurologic Manifestations
Nervous System Diseases