Trial Outcomes & Findings for Study of Low Level Laser Therapy and Tinnitus Relief (NCT NCT00845975)

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 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). A change in total THI score of -20 or greater indicates a meaningful lessening of the impact of tinnitus on the individual's life and is positive for study success.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

18 participants

Primary outcome timeframe

baseline and one week

Results posted on

2014-06-05

Participant Flow

18 subjects were recruited and enrolled in this study between August 26, 2008 and September 16, 2008 at a single medical hearing aid clinic.

There were no significant events or approaches for the overall study following participant enrollment, but prior to group assignment. There were no enrolled participants excluded from the trial before assignment to groups.

Participant milestones

Participant milestones
Measure	Erchonia Hearing Lasers #1 & #2 Erchonia Hearing Laser #1 is a dual laser system composed of a pulsed red 7.5 milliwatts (mW) laser of 635 nm +/- 5 nm and a pulsed green 7.5 mW laser of 532 nm, both lasers in simultaneous operation when the laser is activated. Erchonia Hearing Laser #2 is a single diode laser that in pulsed mode emits 4.9 mW of red 635 nm +/- 5 nm light. Erchonia Hearing Lasers #1 \& #2 : Two treatments with Erchonia Hearing Laser #1 administered by the investigator at the test site, each treatment seven days apart. Seven treatments with the Erchonia Hearing Laser #2 administered by the subject at home, one time each day for seven consecutive days, the first administration on the same day as the first administration with the Erchonia Hearing Laser #1 at the test site.	Placebo Lasers Inactive lasers that do not emit any therapeutic light. Placebo Lasers : The same test site and at-home treatment administration protocols are followed, but the laser devices do not emit any therapeutic light.
Overall Study STARTED	9	9
Overall Study COMPLETED	9	9
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of Low Level Laser Therapy and Tinnitus Relief

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Erchonia Hearing Lasers #1 & #2 n=9 Participants Erchonia Hearing Laser #1 is a dual laser system composed of a pulsed red 7.5 mW laser of 635 nm +/- 5 nm and a pulsed green 7.5 mW laser of 532 nm, both lasers in simultaneous operation when the laser is activated. Erchonia Hearing Laser #2 is a single diode laser that in pulsed mode emits 4.9 mW of red 635 nm +/- 5 nm light. Erchonia Hearing Lasers #1 \& #2 : Two treatments with Erchonia Hearing Laser #1 administered by the investigator at the test site, each treatment seven days apart. Seven treatments with the Erchonia Hearing Laser #2 administered by the subject at home, one time each day for seven consecutive days, the first administration on the same day as the first administration with the Erchonia Hearing Laser #1 at the test site.	Placebo Lasers n=9 Participants Inactive lasers that do not emit any therapeutic light. Placebo Lasers : The same test site and at-home treatment administration protocols are followed, but the laser devices do not emit any therapeutic light.	Total n=18 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Age, Continuous	60 years STANDARD_DEVIATION 9.53 • n=5 Participants	66.18 years STANDARD_DEVIATION 9.10 • n=7 Participants	63.58 years STANDARD_DEVIATION 9.55 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Region of Enrollment United States	9 participants n=5 Participants	9 participants n=7 Participants	18 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline and one 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). A change in total THI score of -20 or greater indicates a meaningful lessening of the impact of tinnitus on the individual's life and is positive for study success.

Outcome measures

Outcome measures
Measure	Erchonia Hearing Lasers #1 & #2 n=9 Participants Erchonia Hearing Laser #1 is a dual laser system composed of a pulsed red 7.5 mW laser of 635 nm +/- 5 nm and a pulsed green 7.5 mW laser of 532 nm, both lasers in simultaneous operation when the laser is activated. Erchonia Hearing Laser #2 is a single diode laser that in pulsed mode emits 4.9 mW of red 635 nm +/- 5 nm light. Erchonia Hearing Lasers #1 \& #2 : Two treatments with Erchonia Hearing Laser #1 administered by the investigator at the test site, each treatment seven days apart. Seven treatments with the Erchonia Hearing Laser #2 administered by the subject at home, one time each day for seven consecutive days, the first administration on the same day as the first administration with the Erchonia Hearing Laser #1 at the test site.	Placebo Lasers n=9 Participants Inactive lasers that do not emit any therapeutic light. Placebo Lasers : The same test site and at-home treatment administration protocols are followed, but the laser devices do not emit any therapeutic light.
Total Score on the Tinnitus Handicap Inventory (THI).	-22.80 units on a scale Standard Deviation 18.63	-16.66 units on a scale Standard Deviation 13.48

SECONDARY outcome

Timeframe: baseline and 4 weeks

The Beck Depression Inventory®-II (BDI®-II) is a 21-item questionnaire used to assess depression. Most items are rated on a 4-point scale from 0 to 3, and a few items are rated on a 7-point scale. Individual item scores are added to get a total score from 0 to 63. The higher the total score, the more severe the depression, and the lower the total score, the less severe the depression. Change in BDI®-II score is calculated as the BDI®-II score 4 weeks after baseline evaluation minus the BDI®-II score at baseline. A positive (+) change in BDI®-II score indicates that the depression has worsened. A negative (-) change in BDI®-II score indicates the depression has lessened. A change in BDI®-II score of -6 or greater indicates a meaningful lessening of depression and is positive for study success.

Outcome measures

Outcome measures
Measure	Erchonia Hearing Lasers #1 & #2 n=9 Participants Erchonia Hearing Laser #1 is a dual laser system composed of a pulsed red 7.5 mW laser of 635 nm +/- 5 nm and a pulsed green 7.5 mW laser of 532 nm, both lasers in simultaneous operation when the laser is activated. Erchonia Hearing Laser #2 is a single diode laser that in pulsed mode emits 4.9 mW of red 635 nm +/- 5 nm light. Erchonia Hearing Lasers #1 \& #2 : Two treatments with Erchonia Hearing Laser #1 administered by the investigator at the test site, each treatment seven days apart. Seven treatments with the Erchonia Hearing Laser #2 administered by the subject at home, one time each day for seven consecutive days, the first administration on the same day as the first administration with the Erchonia Hearing Laser #1 at the test site.	Placebo Lasers n=9 Participants Inactive lasers that do not emit any therapeutic light. Placebo Lasers : The same test site and at-home treatment administration protocols are followed, but the laser devices do not emit any therapeutic light.
Beck Depression Inventory-II (BDI-II)	-4.3 units on a scale Standard Deviation 3.56	-2.5 units on a scale Standard Deviation 1.98

SECONDARY outcome

Timeframe: baseline and 4 weeks

The Trait portion of the State-Trait Anxiety Inventory (STAI-T) evaluates an individual's tendency to get anxious and how they respond to stress. The STAI-T has 20 items rated on a 4-point frequency of occurrence scale of 1=Almost Never, 2=Sometimes, 3=Moderately So, and 4=Very Much So. The individual scores are summed to get the total STAI-T score. The higher the total score, the more anxious the individual, and the lower the total score, the less anxious the individual. Change in STAI-T score is calculated as the STAI-T score at 4 weeks after baseline evaluation minus the STAI-T score at baseline. A positive (+) change in STAI-T score indicates that the anxiety has worsened. A negative (-) change in STAI-T score indicates the depression has lessened. A change in STAI-T score of -8 or greater indicates a meaningful lessening of anxiety and is positive for study success.

Outcome measures

Outcome measures
Measure	Erchonia Hearing Lasers #1 & #2 n=9 Participants Erchonia Hearing Laser #1 is a dual laser system composed of a pulsed red 7.5 mW laser of 635 nm +/- 5 nm and a pulsed green 7.5 mW laser of 532 nm, both lasers in simultaneous operation when the laser is activated. Erchonia Hearing Laser #2 is a single diode laser that in pulsed mode emits 4.9 mW of red 635 nm +/- 5 nm light. Erchonia Hearing Lasers #1 \& #2 : Two treatments with Erchonia Hearing Laser #1 administered by the investigator at the test site, each treatment seven days apart. Seven treatments with the Erchonia Hearing Laser #2 administered by the subject at home, one time each day for seven consecutive days, the first administration on the same day as the first administration with the Erchonia Hearing Laser #1 at the test site.	Placebo Lasers n=9 Participants Inactive lasers that do not emit any therapeutic light. Placebo Lasers : The same test site and at-home treatment administration protocols are followed, but the laser devices do not emit any therapeutic light.
Spielberger State-Trait Anxiety Inventory (STAI)- Trait Portion	-0.2 units on a scale Standard Deviation 1.32	-2.88 units on a scale Standard Deviation 3.45

Adverse Events

Erchonia Hearing Lasers #1 & #2

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo Lasers

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

Louis A Looper, MA, CCC-A

McDonald hearing Aid Centers

Phone: 916-218-4100

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place