Trial Outcomes & Findings for Effect of the Erchonia® HLS™ for the Relief of Tinnitus Symptoms (NCT NCT05091060)

Last Updated: 2023-08-30

Results Overview

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).

Recruitment status

TERMINATED

Study phase

Target enrollment

5 participants

Primary outcome timeframe

Baseline and 8 week

Results posted on

2023-08-30

Participant Flow

Participant milestones

Participant milestones
Measure	Erchonia HLS 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 Study STARTED	5
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Erchonia HLS 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 Study Lost to Follow-up	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Erchonia HLS n=5 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	58.25 years STANDARD_DEVIATION 4.65 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 8 week

Outcome measures

Outcome measures
Measure	Erchonia HLS n=4 Participants 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.
Total Score on the Tinnitus Handicap Inventory (THI).	-24 score on a scale Standard Deviation 10.09

Adverse Events

Erchonia HLS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Travis Sammons

Erchonia Corporation

Phone: 3214731251

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place