Behavioural Intervention

Oasis™ device for Tinnitus

U.S. Army Aeromedical Research Laboratory, Fort Rucker, AL

Neuromonics Tinnitus Treatment Program +1 moreN/AWaitlist AvailableLed by William A Ahroon, Ph.D.Research Sponsored by United States Army Aeromedical Research Laboratory

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Must not have

Be younger than 18 years old

Be older than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Upbaseline and six months after enrollment

Awards & highlights

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.

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and two, four, and six months after enrollment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and two, four, and six months after enrollment

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and two, four, and six months after enrollment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Tinnitus Reaction Questionnaire (TRQ)

Secondary outcome measures

Hospital Anxiety and Depression Scale (HADS)

Loudness Discomfort Levels (LDL) (an audiometric test)

Minimum Masking Level (MML) (an audiometric test)

+4 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Oasis™ deviceExperimental Treatment1 Intervention

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

Group II: Placebo devicePlacebo Group1 Intervention

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

0 / 7Eligibility criteria met

Find a site

Who is running the clinical trial?

United States Army Aeromedical Research LaboratoryLead Sponsor

4 Previous Clinical Trials

146 Total Patients Enrolled

Congressionally Directed Medical Research ProgramsFED

40 Previous Clinical Trials

6,333 Total Patients Enrolled

William A Ahroon, Ph.D.Principal Investigator

U.S. Army Aeromedical Research Laboratory

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?

Alabama

Florida

How old are they?

65+

18 - 65

What site did they apply to?

U.S. Army Aeromedical Research Laboratory

What portion of applicants met pre-screening criteria?

Met criteria

Recent research and studies

clinicaltrials.govStudy

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

William A. Ahroon, Ph.D. 2016. "Treating Tinnitus Using the Neuromonics Tinnitus Treatment Program: A Randomized, Double-blind Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02829073.

~14 spots leftby Sep 2024

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