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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 Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Tinnitus
Intervention Device: Erchonia HLS
Enrollment 5
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Erchonia HLS
Hide Arm/Group Description

635 nanometers (nm) laser application

Erchonia HLS: 56 procedure administrations with the Erchonia® HLS™ administered by the subject at home: daily procedure administrations for 8 weeks.
Period Title: Overall Study
Started 5
Completed 4
Not Completed 1
Reason Not Completed
Lost to Follow-up             1
Arm/Group Title Erchonia HLS
Hide Arm/Group Description

635 nanometers (nm) laser application

Erchonia HLS: 56 procedure administrations with the Erchonia® HLS™ administered by the subject at home: daily procedure administrations for 8 weeks.
Overall Number of Baseline Participants 5
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
<=18 years
0
   0.0%
Between 18 and 65 years
5
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 5 participants
58.25  (4.65)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
Female
3
  60.0%
Male
2
  40.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
5
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 5 participants
5
1.Primary Outcome
Title Total Score on the Tinnitus Handicap Inventory (THI).
Hide Description 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).
Time Frame Baseline and 8 week
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Erchonia HLS
Hide Arm/Group Description:

635 nanometers (nm) laser application

Erchonia HLS: 56 procedure administrations with the Erchonia® HLS™ administered by the subject at home: daily procedure administrations for 8 weeks.
Overall Number of Participants Analyzed 4
Mean (Standard Deviation)
Unit of Measure: score on a scale
-24  (10.09)
Time Frame 8 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Erchonia HLS
Hide Arm/Group Description

635 nanometers (nm) laser application

Erchonia HLS: 56 procedure administrations with the Erchonia® HLS™ administered by the subject at home: daily procedure administrations for 8 weeks.
All-Cause Mortality
Erchonia HLS
Affected / at Risk (%)
Total   0/4 (0.00%) 
Hide Serious Adverse Events
Erchonia HLS
Affected / at Risk (%)
Total   0/4 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Erchonia HLS
Affected / at Risk (%)
Total   0/4 (0.00%) 
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Travis Sammons
Organization: Erchonia Corporation
Phone: 3214731251
EMail: tsammons@erchonia.com
Layout table for additonal information
Responsible Party: Erchonia Corporation
ClinicalTrials.gov Identifier: NCT05091060    
Other Study ID Numbers: R-Tinnitus-Pilot
First Submitted: October 12, 2021
First Posted: October 25, 2021
Results First Submitted: July 12, 2023
Results First Posted: August 1, 2023
Last Update Posted: August 30, 2023