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Study of Low Level Laser Therapy and Word Recognition in Hearing Impaired Individuals

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ClinicalTrials.gov Identifier: NCT00787189
Recruitment Status : Completed
First Posted : November 7, 2008
Results First Posted : July 11, 2011
Last Update Posted : April 24, 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 Sensorineural Hearing Loss
Interventions Device: The Hearing Laser
Device: Placebo Laser
Enrollment 80
Recruitment Details 40 subjects (80 ears) were recruited across two hearing aid and evaluation test sites from May, 2007 to October, 2008.
Pre-assignment Details 4 subjects (8 ears) were disqualified because the word recognition score recorded for study qualification purposes exceeded the upper inclusive limit of 86% words correct. 4 subjects (8 ears) were disqualified because the subject’s primary spoken language was not English, which was also a study exclusion criteria.
Arm/Group Title Active Control
Hide Arm/Group Description Active laser device Placebo laser device
Period Title: Overall Study
Started 32 32
Completed 30 [1] 30 [1]
Not Completed 2 2
Reason Not Completed
Lost to Follow-up             2             2
[1]
To study end point.
Arm/Group Title Active Control Total
Hide Arm/Group Description Active laser device Placebo laser device Total of all reporting groups
Overall Number of Baseline Participants 32 32 64
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 32 participants 64 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
6
  18.8%
0
   0.0%
6
   9.4%
>=65 years
26
  81.3%
32
 100.0%
58
  90.6%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 32 participants 32 participants 64 participants
78.94  (5.92) 76.00  (9.86) 77.47  (8.265)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 32 participants 64 participants
Female
10
  31.3%
18
  56.3%
28
  43.8%
Male
22
  68.8%
14
  43.8%
36
  56.3%
1.Primary Outcome
Title Participants Whose Change in Percent Correct Word Recognition Scores From Baseline to One Week After Study Treatment Equalled or Exceeded the Minimum Change in a Reference Chart.
Hide Description Participants were asked to repeat 50 words presented one at a time through headphones to each ear separately at a comfortable listening level to the participant. The 50 words were from a phonetically-balanced list of monosyllabic words called the CID W-22 lists. The percent of total words repeated correctly for each ear was recorded and the change in this percent from baseline to one week after study treatment was referenced against a chart. If the change was equal to or greater than the corresponding value in the chart, the participant was considered to have a successful study outcome.
Time Frame baseline and one week
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT analysis.
Arm/Group Title Active Control
Hide Arm/Group Description:
Active laser device
Placebo laser device
Overall Number of Participants Analyzed 32 32
Measure Type: Number
Unit of Measure: participants
15 2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Active, Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0005
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
2.Secondary Outcome
Title Tinnitus, Hearing-related Quality of Life
Hide Description [Not Specified]
Time Frame up to 6 months
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Active Control
Hide Arm/Group Description Active laser device Placebo laser device
All-Cause Mortality
Active Control
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Active Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/32 (0.00%)   0/32 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Active Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/32 (0.00%)   0/32 (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: Elvira Walls, Clinical Consultant
Organization: Regulatory Insight, Inc.
Phone: 615-712-9743
Responsible Party: Erchonia Corporation
ClinicalTrials.gov Identifier: NCT00787189     History of Changes
Other Study ID Numbers: EHL-001
First Submitted: November 6, 2008
First Posted: November 7, 2008
Results First Submitted: June 23, 2009
Results First Posted: July 11, 2011
Last Update Posted: April 24, 2014