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
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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 |
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Tinnitus | Device: Neuromonics Tinnitus Treatment Program Device: Placebo Device | Not Applicable |

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 |
Arm | Intervention/treatment |
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Experimental: Oasis™ device
Treatment using the Neuromonics Tinnitus Treatment Program and the Neuromonics Oasis™ treatment device.
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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.
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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. |
- 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
- 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
- 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
- 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
- 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
- Hospital Anxiety and Depression Scale (HADS) [ Time Frame: Baseline and six months after enrollment ]Change in HADS score at 6 months compared to baseline
- Minimum Masking Level (MML) (an audiometric test) [ Time Frame: Baseline and six months after enrollment ]Change in MML at 6 months compared to baseline
- Loudness Discomfort Levels (LDL) (an audiometric test) [ Time Frame: Baseline and six months after enrollment ]Change in LDL at 6 months compared to baseline

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

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
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. |
Principal Investigator: | William A Ahroon, Ph.D. | U.S. Army Aeromedical Research Laboratory |
Responsible Party: | William A. Ahroon, Ph.D., Psychologist (Research), United States Army Aeromedical Research Laboratory |
ClinicalTrials.gov Identifier: | NCT02829073 |
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 |
Tinnitus Double-blind Neuromonic Tinnitus Treatment Program Oasis™ |
Tinnitus Hearing Disorders Ear Diseases Otorhinolaryngologic Diseases |
Sensation Disorders Neurologic Manifestations Nervous System Diseases |