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Study of Low Level Laser Therapy and Tinnitus Relief

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ClinicalTrials.gov Identifier: NCT00845975
Recruitment Status : Terminated (New information suggested a more effective treatment protocol.)
First Posted : February 18, 2009
Results First Posted : June 5, 2014
Last Update Posted : June 5, 2014
Sponsor:
Information provided by (Responsible Party):
Erchonia Corporation

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Tinnitus
Interventions Device: Erchonia Hearing Lasers #1 & #2
Device: Placebo Lasers
Enrollment 18
Recruitment Details 18 subjects were recruited and enrolled in this study between August 26, 2008 and September 16, 2008 at a single medical hearing aid clinic.
Pre-assignment Details 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.
Arm/Group Title Erchonia Hearing Lasers #1 & #2 Placebo Lasers
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 9 9
Completed 9 9
Not Completed 0 0
Arm/Group Title Erchonia Hearing Lasers #1 & #2 Placebo Lasers Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 9 9 18
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 9 participants 18 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
5
  55.6%
4
  44.4%
9
  50.0%
>=65 years
4
  44.4%
5
  55.6%
9
  50.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 9 participants 9 participants 18 participants
60  (9.53) 66.18  (9.10) 63.58  (9.55)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 9 participants 18 participants
Female
6
  66.7%
7
  77.8%
13
  72.2%
Male
3
  33.3%
2
  22.2%
5
  27.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 9 participants 9 participants 18 participants
9 9 18
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 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.
Time Frame baseline and one week
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Erchonia Hearing Lasers #1 & #2 Placebo Lasers
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 9 9
Mean (Standard Deviation)
Unit of Measure: units on a scale
-22.80  (18.63) -16.66  (13.48)
2.Secondary Outcome
Title Beck Depression Inventory-II (BDI-II)
Hide Description 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.
Time Frame baseline and 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Erchonia Hearing Lasers #1 & #2 Placebo Lasers
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 9 9
Mean (Standard Deviation)
Unit of Measure: units on a scale
-4.3  (3.56) -2.5  (1.98)
3.Secondary Outcome
Title Spielberger State-Trait Anxiety Inventory (STAI)- Trait Portion
Hide Description 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.
Time Frame baseline and 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Erchonia Hearing Lasers #1 & #2 Placebo Lasers
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 9 9
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.2  (1.32) -2.88  (3.45)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Erchonia Hearing Lasers #1 & #2 Placebo Lasers
Hide Arm/Group Description

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.

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.

All-Cause Mortality
Erchonia Hearing Lasers #1 & #2 Placebo Lasers
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Erchonia Hearing Lasers #1 & #2 Placebo Lasers
Affected / at Risk (%) Affected / at Risk (%)
Total   0/9 (0.00%)   0/9 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Erchonia Hearing Lasers #1 & #2 Placebo Lasers
Affected / at Risk (%) Affected / at Risk (%)
Total   0/9 (0.00%)   0/9 (0.00%) 
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
Name/Title: Louis A Looper, MA, CCC-A
Organization: McDonald hearing Aid Centers
Phone: 916-218-4100
Responsible Party: Erchonia Corporation
ClinicalTrials.gov Identifier: NCT00845975     History of Changes
Other Study ID Numbers: TS-001
First Submitted: February 16, 2009
First Posted: February 18, 2009
Results First Submitted: April 11, 2013
Results First Posted: June 5, 2014
Last Update Posted: June 5, 2014