Recruiting

Neuromonics

Sponsor:

United States Army Aeromedical Research Laboratory

Code:

NCT02829073

Conditions

Tinnitus

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Accepted

Interventions

Neuromonics Tinnitus Treatment Program

Placebo Device

Study Details

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.

Conditions

Tinnitus

Study ID

NCT02829073

Start date

Apr, 2016

Status verified date

May, 2017

Completion date

Dec, 2017

Anticipated

Primary completion date

Dec, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Oasis™ device

Treatment using the Neuromonics Tinnitus Treatment Program and the Neuromonics Oasis™ treatment device.

placebo comparator: Placebo device

Treatment using the Neuromonics Tinnitus Treatment Program and an identical-appearing placebo device.

Interventions

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.

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 measure

  • Tinnitus Reaction Questionnaire (TRQ) [ Time Frame: Baseline and two, four, and six months after enrollment ]

Central Contacts and Locations

Locations

U.S. Army Aeromedical Research Laboratory

Recruiting

Fort Rucker, Alabama, United States, 36362-0577

Contacts

Stephanie J Karch, Au.D., Ph.D.

334-255-6827stephanie.j.karch.civ@mail.mil

William A Ahroon, Ph.D.

334-255-6828william.a.ahroon.civ@mail.mil

More Information

Sponsor

United States Army Aeromedical Research Laboratory

Last update posted

May 2, 2017

Last verified

May, 2017

Keywords

  • Tinnitus
  • Double-blind
  • Neuromonic Tinnitus Treatment Program
  • Oasis™

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-29. This information was provided to ClinicalTrials.gov by United States Army Aeromedical Research Laboratory on 2017-05-02. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.