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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 : Active, not recruiting
First Posted : October 25, 2021
Last Update Posted : November 23, 2021
Sponsor:
Information provided by (Responsible Party):
Erchonia Corporation

Tracking Information
First Submitted Date  ICMJE October 12, 2021
First Posted Date  ICMJE October 25, 2021
Last Update Posted Date November 23, 2021
Actual Study Start Date  ICMJE June 10, 2021
Estimated Primary Completion Date January 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 12, 2021)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of the Erchonia® HLS™ for the Relief of Tinnitus Symptoms
Official Title  ICMJE Erchonia and InnerScope, Pilot Evaluation of the Effect of the Erchonia® HLS™ for the Relief of Tinnitus Symptoms
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Tinnitus
Intervention  ICMJE Device: Erchonia HLS
56 procedure administrations with the Erchonia® HLS™ administered by the subject at home: daily procedure administrations for 8 weeks.
Study Arms  ICMJE Experimental: Erchonia HLS
635 nanometers (nm) laser application
Intervention: Device: Erchonia HLS
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: October 12, 2021)
5
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2022
Estimated Primary Completion Date January 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05091060
Other Study ID Numbers  ICMJE R-Tinnitus-Pilot
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Erchonia Corporation
Study Sponsor  ICMJE Erchonia Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Erchonia Corporation
Verification Date November 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP