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

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.

Conditions

• Tinnitus

Interventions

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.

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.

Sponsors & Collaborators

• Congressionally Directed Medical Research Programs

  collaborator FED

• United States Army Aeromedical Research Laboratory

  lead FED

Principal Investigators

• William A Ahroon, Ph.D. · U.S. Army Aeromedical Research Laboratory

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2016-04-30

Primary Completion

2017-12-31

Completion

2017-12-31

Countries

• United States

Study Locations