Study of Low Level Laser Therapy and Tinnitus Relief

NCT00845975 | Terminated Results DMC

• 1 other identifier: TS-001
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if low level laser light therapy might help to relieve tinnitus in adults.

Conditions

Tinnitus

Outcome Measures

Primary Outcomes (1)

• Total Score on the Tinnitus Handicap Inventory (THI).

  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.

  baseline and one week

Secondary Outcomes (2)

• Beck Depression Inventory-II (BDI-II)

  baseline and 4 weeks

• Spielberger State-Trait Anxiety Inventory (STAI)- Trait Portion

  baseline and 4 weeks

Study Arms (2)

Erchonia Hearing Lasers #1 & #2

ACTIVE COMPARATOR

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.

Device: Erchonia Hearing Lasers #1 & #2

Placebo Lasers

PLACEBO COMPARATOR

Inactive lasers that do not emit any therapeutic light.

Device: Placebo Lasers

Interventions

Erchonia Hearing Lasers #1 & #2 DEVICE

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.

Erchonia Hearing Lasers #1 & #2

Placebo Lasers DEVICE

The same test site and at-home treatment administration protocols are followed, but the laser devices do not emit any therapeutic light.

Placebo Lasers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Total score on the Tinnitus Handicap Inventory (THI) of at least 20.
• Tinnitus is on-going; present for more than 50% of the time over the past 6 months.
• Subject has been previously evaluated by a qualified health care professional for tinnitus and received a diagnosis of etiology of tinnitus related to hearing impairment and/or noise exposure and/or unknown.
• Any existing hearing loss stable over the past 12 months.
• Willing and able to refrain from engaging in activities or work involving loud noise exposure, such as hunting, rock concerts and work situations that involve working around loud machinery, construction sites, etc., throughout the course of study participation.
• years or older.
• Male or female.
• English as primary spoken language.

You may not qualify if:

• Presence of any of the following or in the subject's medical history:
• physical trauma or surgery to the head or neck
• uncontrolled hypertension
• current or prior surgically removed acoustic neuroma middle ear infection/active drainage from the ear and/or history of either within the previous 90 days
• impacted cerumen
• thyroid disease
• vascular disorders
• Temporomandibular Joint Disorder (TMJD)
• nutritional deficiency
• aneurysm
• multiple sclerosis
• Episodic or infrequent tinnitus
• Somatic or pulsatile tinnitus
• Prior history of sudden hearing loss and/or fluctuating hearing levels .
• Consistent use of any of the following drugs within the past 30 days:

Sponsors & Collaborators

• Erchonia Corporation: lead

Study Sites (1)

McDonald Hearing Aid Center

Sacramento, California, 95825, United States

Location

MeSH Terms

Conditions

Tinnitus

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Louis A Looper, MA, CCC-A
• Organization: McDonald hearing Aid Centers

llooper@hearingmed.com

916-218-4100

Study Officials

• Louis A Looper, MA, CCC-A

  McDonald Hearing Aid Centers

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2009
• First Posted: February 18, 2009
• Study Start: August 1, 2008
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: June 5, 2014
• Results First Posted: June 5, 2014

Record last verified: 2014-05

Locations

US (1)