Effect of the Erchonia® HLS™ for the Relief of Tinnitus Symptoms
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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
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Sponsor:
Erchonia Corporation
Information provided by (Responsible Party):
Erchonia Corporation
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Tracking Information | |||||||||
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First Submitted Date ICMJE | October 12, 2021 | ||||||||
First Posted Date ICMJE | October 25, 2021 | ||||||||
Results First Submitted Date ICMJE | July 12, 2023 | ||||||||
Results First Posted Date ICMJE | August 1, 2023 | ||||||||
Last Update Posted Date | August 30, 2023 | ||||||||
Actual Study Start Date ICMJE | June 10, 2021 | ||||||||
Actual Primary Completion Date | March 14, 2022 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
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).
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Original Primary Outcome Measures ICMJE |
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).
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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 |
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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.
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Study Arms ICMJE | Experimental: Erchonia HLS
635 nanometers (nm) laser application
Intervention: Device: Erchonia HLS
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Terminated | ||||||||
Actual Enrollment ICMJE |
5 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Actual Study Completion Date ICMJE | March 14, 2022 | ||||||||
Actual Primary Completion Date | March 14, 2022 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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
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Sex/Gender ICMJE |
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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 |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Erchonia Corporation | ||||||||
Original Responsible Party | Same as current | ||||||||
Current Study Sponsor ICMJE | Erchonia Corporation | ||||||||
Original Study Sponsor ICMJE | Same as current | ||||||||
Collaborators ICMJE | Not Provided | ||||||||
Investigators ICMJE | Not Provided | ||||||||
PRS Account | Erchonia Corporation | ||||||||
Verification Date | August 2023 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |