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Treating Tinnitus Using the Neuromonics Tinnitus Treatment Program: A Randomized, Double-blind Study

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ClinicalTrials.gov Identifier: NCT02829073
Recruitment Status : Unknown
Verified May 2017 by William A. Ahroon, Ph.D., United States Army Aeromedical Research Laboratory.
Recruitment status was:  Recruiting
First Posted : July 12, 2016
Last Update Posted : May 2, 2017
Sponsor:
Collaborator:
Congressionally Directed Medical Research Programs
Information provided by (Responsible Party):
William A. Ahroon, Ph.D., United States Army Aeromedical Research Laboratory

Brief Summary:

The most current data indicate that tinnitus and hearing impairment are the Number 1 and 2 disabilities associated with service in Operations Iraqi Freedom and Enduring Freedom. Tinnitus can result from exposure to continuous noise from vehicles, generators, and other equipment, and from blast, or impulse noise from friendly-or opposing-forces weapon systems. Thus, tinnitus caused by both long-term noise exposure and acute acoustic trauma is an obstacle to be overcome in return-to-duty decisions and represents a serious liability to the retention of a healthy and fit force. Until recently, there has been no treatment that has been clinically validated as consistently effective. The development of the Neuromonics Tinnitus Treatment sought to overcome the practical limitations of previously available approaches (e.g. tinnitus maskers and biofeedback). While these studies have demonstrated the efficacy of the Neuromonics Tinnitus Treatment over alternative therapies, these trials studied target populations that may not be representative of the typical Soldier experiencing tinnitus.

One hundred and twenty (120) Soldiers or veterans with debilitating tinnitus will be recruited and divided into groups treated with two treatments, the Neuromonics Tinnitus Treatment Program which includes the use of the Neuromonics Oasis™ treatment device and a similarly-treated device using a placebo treatment. The study uses a randomized, double-blind design. The effectiveness of the treatments will be assessed using standard audiometric procedures and tinnitus subjective questionnaires.

This study will allow the Office of the Surgeon General of the Army to provide direction regarding the Neuromonics Tinnitus Treatment Program (NTTP) for alleviation of debilitating tinnitus that adversely affects Soldier deployability and operational performance. Retention of a fit force and improved quality of life for active-duty Soldiers are important issues associated with a successful approach to the treatment of tinnitus.


Condition or disease Intervention/treatment Phase
Tinnitus Device: Neuromonics Tinnitus Treatment Program Device: Placebo Device Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Treating Tinnitus Using the Neuromonics Tinnitus Treatment Program: A Randomized, Double-blind Study
Study Start Date : April 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tinnitus

Arm Intervention/treatment
Experimental: Oasis™ device
Treatment using the Neuromonics Tinnitus Treatment Program and the Neuromonics Oasis™ treatment device.
Device: Neuromonics Tinnitus Treatment Program
The Neuromonics Oasis™ treatment device will be fit to individuals reporting significant tinnitus. Assessment of primary and secondary measures will be made at 0 and 6 months following fitting.
Other Name: Neuromonics Oasis™ treatment device

Placebo Comparator: Placebo device
Treatment using the Neuromonics Tinnitus Treatment Program and an identical-appearing placebo device.
Device: Placebo Device
A placebo device, identical to the Neuromonics Oasis™ device with altered firmware will be fit to individuals reporting significant tinnitus. Assessment of primary and secondary measures will be made at 0 and 6 months following fitting.




Primary Outcome Measures :
  1. Tinnitus Reaction Questionnaire (TRQ) [ Time Frame: Baseline and two, four, and six months after enrollment ]
    Change in TRQ score at 6 months compared to baseline


Secondary Outcome Measures :
  1. Tinnitus Reaction Questionnaire (TRQ) Midterm [ Time Frame: Baseline and two, four, and six months after enrollment ]
    Change in TRQ score at 2 and 4 months compared to baseline

  2. Tinnitus Reaction Questionnaire (TRQ) Awareness [ Time Frame: Baseline and two, four, and six months after enrollment ]
    Change of tinnitus awareness at 2, 4, and 6 months compared to baseline

  3. Tinnitus Reaction Questionnaire (TRQ) Bothersome [ Time Frame: Initial and two, four, and six months after enrollment ]
    Change of bothersome tinnitus at 2, 4, and 6 months compared to baseline

  4. PTSD Checklist-Military (PCL-M) [ Time Frame: Baseline and two, four, and six months after enrollment ]
    Change in PLC-M score at 2, 4, and 6 months compared to baseline

  5. Hospital Anxiety and Depression Scale (HADS) [ Time Frame: Baseline and six months after enrollment ]
    Change in HADS score at 6 months compared to baseline

  6. Minimum Masking Level (MML) (an audiometric test) [ Time Frame: Baseline and six months after enrollment ]
    Change in MML at 6 months compared to baseline

  7. Loudness Discomfort Levels (LDL) (an audiometric test) [ Time Frame: Baseline and six months after enrollment ]
    Change in LDL at 6 months compared to baseline



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • If an active duty military personnel, must be between the ages of 18 to 60 years at the time of enrollment.
  • If a veteran, must be between the ages of 19 to 60 years at the time of enrollment
  • Tinnitus disturbance determined at the initial pre-enrollment assessment to be clinically significant, as denoted by a score on the TRQ of 17-70; and
  • Four frequency (0.5, 1, 2, and 4 kHz) pure tone average in one ear (0.5, 1, 2, and 4 kHz) is equal to or less than 50dB HL, as determined by audiometry performed at the initial pre-enrollment assessment; and
  • Cognitive, comprehension and manual dexterity abilities sufficient to self-administer treatment, and ability to travel to attend appointments, as necessary, as determined at the initial pre-enrollment assessment; and
  • Motivated to pursue treatment and has appropriate expectations as to treatment outcomes (including the possibility of being assigned to the placebo group), as determined at the initial pre-enrollment assessment.
  • Must have access to healthcare for follow-up care for the six month study period

Exclusion Criteria:

  • Refusal to give consent
  • Significant psychological disturbance [defined as any rating other than 0 on Question Number 24 the TRQ (suicidal ideology) or a score of more than 78 on the Tinnitus Handicap Inventory (THI)] that may interfere with the treatment as assessed by the treating clinician and/or referring physician;
  • Complicating medical conditions such as acute/unstable Meniere's disease as inferred by responses on the Tinnitus History Questionnaire (THQ);
  • Ongoing use of ototoxic medications (THQ);
  • Pulsatile tinnitus (THQ);
  • Continued excessive noise exposure without effective hearing protection (THQ);
  • After all elements of informed consent are completed and the TRQ has been scored, a score of less than 17 will exclude the volunteer from participation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02829073


Locations
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United States, Alabama
U.S. Army Aeromedical Research Laboratory Recruiting
Fort Rucker, Alabama, United States, 36362-0577
Contact: Stephanie J Karch, Au.D., Ph.D.    334-255-6827    stephanie.j.karch.civ@mail.mil   
Contact: William A Ahroon, Ph.D.    334-255-6828    william.a.ahroon.civ@mail.mil   
Sub-Investigator: Lynnette B Bardolf, Ph.D.         
Sponsors and Collaborators
United States Army Aeromedical Research Laboratory
Congressionally Directed Medical Research Programs
Investigators
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Principal Investigator: William A Ahroon, Ph.D. U.S. Army Aeromedical Research Laboratory

Publications:
Karch, S.J., et al., Evaluation of Sound Therapy Tinnitus Treatments with Concurrent Counseling in Active Duty Military Personnel. 2014, U.S. Army Aeromedical Research Laboratory: Fort Rucker, AL.
Karch, S. J., Hill, M. M., Casto, K. L., Nedostup, A. E., & Staton, R. N. (2014). Evaluation of Sound Therapy Tinnitus Treatments with Concurrent Counseling in Active Duty Military Personnel. (Report 2014-022). Fort Rucker, AL: U.S. Army Aeromedical Research Laboratory.
US Department of Veterans Affairs. (2010). 2010 Annual Benefits Report. Retrieved from www.vba.va.gov/REPORTS/abr/2010_abr.pdf.
McKinney, C.J., J.W. Hazell, and R.L. Graham, An evaluation of the TRT method, in Proceedings of the sixth international tinnitus seminar, J.W. Hazell, Editor. 1999. p. 99-105.
Schmitt, C. and B. Kroner-Herwig, Comparison of tinnitus coping training and TRT: Are they superior to education?, in Proceedings of the Seventh International Tinnitus Seminar, R. Patuzzi, Editor. 2002, Hawthorn Production Services: Norfolk, VA. p. 273-276.
Tyler, R.S., Final Report: A preliminary investigation of the effectiveness of tinnitus retraining therapy. Tinnitus Today, 2004. 29: p. 12.
Henry, J.A., et al., Tinnitus retraining therapy and masking; how do they compare?, in Proceedings of the Seventh International Tinnitus Seminar, R. Patuzzi, Editor. 2002, Hawthorn Production Services: Norfolk, VA. p. 247-254.
Tyler, R.S., Neurophysiological models, psychological models, and treatments for tinnitus, in Tinnitus Treatments: Clinical Protocols, R.S. Tyler, Editor. 2005, Thieme Medical Publishers: New York. p. 1-22.
Davis, P.B., R.A. Wilde, and L.G. Steed. Clinical trial findings of a neurophysiologically-based tinnitus rehabilitation technique using tinnitus desensitization music. in Proceedings of the Seventh International Tinnitus Seminar. 2002. Perth: University of Western Australia.
Davis, P.B., Music and the acoustic desensitization protocol for tinnitus., in Tinnitus treatments R.S. Tyler, Editor. 2005, Thieme: New York.

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Responsible Party: William A. Ahroon, Ph.D., Psychologist (Research), United States Army Aeromedical Research Laboratory
ClinicalTrials.gov Identifier: NCT02829073     History of Changes
Other Study ID Numbers: USAARL 2014-045; IRB M-10464
First Posted: July 12, 2016    Key Record Dates
Last Update Posted: May 2, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by William A. Ahroon, Ph.D., United States Army Aeromedical Research Laboratory:
Tinnitus
Double-blind
Neuromonic Tinnitus Treatment Program
Oasis™
Additional relevant MeSH terms:
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Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms