Reviewed by Michael Gill, B. Sc.
Image of U.S. Army Aeromedical Research Laboratory in Fort Rucker, United States.
Phase-Based Progress Estimates
1
Effectiveness
1
Safety

Oasis™ Devicefor Tinnitus

18 - 65
All Sexes
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.
Waitlist Available
Device
U.S. Army Aeromedical Research LaboratoryWilliam A Ahroon, Ph.D.
23 Tinnitus Clinical Trials Near Me
Top Hospitals for Tinnitus Clinical Trials
Image of Michigan Ear Institute in Michigan.
Michigan Ear Institute
Farmington Hills
3Active Trials
2All Time Trials for Tinnitus
2021First Tinnitus Trial
Image of VA Portland Health Care System, Portland, OR in Oregon.
VA Portland Health Care System, Portland, OR
Portland
2Active Trials
7All Time Trials for Tinnitus
2010First Tinnitus Trial
Top Cities for Tinnitus Clinical Trials
Image of Chicago in Illinois.
Chicago
4Active Trials
Center for Translational Imaging at Northwestern UniversityTop Active Site
Image of New York in New York.
New York
4Active Trials
Columbia University Medical CenterTop Active Site
Top Treatments for Tinnitus Clinical Trials
Treatment Name
Active Tinnitus Clinical Trials
All Time Trials for Tinnitus
First Recorded Tinnitus Trial
Lenire bimodal stimulation device
1
1
2022
Internal Jugular Vein Compression Collar
1
1
2022
Physical Therapy
1
2
2019
Erchonia® THL™
1
1
2022
Amplification-only
1
1
2022

What is Tinnitus?

Tinnitus is an audio condition wherein individuals hear a sound despite not having a source. The most common sounds are ringing, hissing, humming, crickets, and buzzing. It is heavily linked to hearing loss or the deterioration of it, as well as acoustic neuroma and depression. Though it is not anything serious medically, the sounds disrupt the daily lives of patients.

Why is Tinnitus Being Studied in Clinical Trials?

Tinnitus remains to be without any clear treatment or complete cure. Around 50 million people in America have chronic tinnitus; out of this number, 10 million sustain bothersome tinnitus. Patients have to undergo heavy therapy to have a go at a remedy, and even the success rate of this is very low. Tinnitus treatments aim to discover a fully functional and safe cure to the phantom sound that patients hear.

How Do Tinnitus Clinical Trials Work?

As tinnitus clinical trials aim to reduce the perceived sounds, multiple methods have been tested. Most clinical trials will require a large number of participants with tinnitus in order to achieve a larger spread of results. Thes studies usually involve involve splitting into groups and distributing various alternative treatments.

Everything from drugs to neuromodulation to noninvasive hearing devices has been attempted in separate clinical trials.

What Are Some Key Breakthrough Clinical Trials Involving Tinnitus?

2022: A bimodal neuromodulation approach to tinnitus treatment, which is a previous method tested in animals, was tested to see whether or not the same electrical somatosensory phenomenon can occur in humans. A device that transmits sound to the ears and to the tongue was tested on 326 adult patients. Different settings on the device were set to test out on three different subject groups, to be conducted over 12 weeks. Participants noticed a significant decrease in tinnitus symptoms afterward. The results motivated further clinical trials in making bimodal neuromodulation a viable device treatment for tinnitus.

2020: A study conducted by researchers from the University of Auckland in New Zealand offered encouraging results arising from their mobile-phone-based therapy for tinnitus. They gathered 60 participants who had tinnitus and split them into two groups, assigning them to different treatments. Half of the group was given a prototype digital therapeutic, while the other half was given a self-help passive sound therapy app called White Noise Lite (WN). After 12 weeks of continuous use and observation, the group with the digital therapeutic reported a significant improvement in their coping and symptoms than the group with the WN. This study is important because it introduced a new method other than the mainstream White Noise Lite (WN).

Who Are the Key Opinion Leaders On Tinnitus Clinical Trial Research?

Berthold Langguth is considered an expert on psychotherapy, psychiatry, neurology, and pain medicine. He founded the tinnitus research initiative in 2006 and is still an important part of the executive committee to this day.

Deborah Hall Ph.D. is an awardee of the Thomas Simm Littzer prize, as well as a recipient of the Marie and Jack Shapiro prize from the British Tinnitus Association. Deborah Hall is one of the leading experts in audiology and psychology. She is currently the head of the department of Psychology at Heriot-Watt University in Malaysia, but she was previously an active figure in Tinnitus research across the United Kingdom.

Top Hospitals For Tinnitus Clinical Trials

Tinnitus labs and research facilities are organized all over the United States. We found that the Michigan Ear Institute in Farmington Hills currently has the most active Tinnitus Clinical trials, with three (3) clinical studies open for recruitment. They started their first clinical study in 2021. The Michigan Ear institute specializes in everything that has to do with hearing - from diagnosis to treatment of ear-related conditions. It was first established in 1986 and had since then helped over 1500 children and adults with their cochlear implants.

Looking at the VA Portland Health Care System in Oregon, trials were first conducted way back in 2010, with seven (7) successful trials completed since the first one. The health facility receives 80,000 annual visits and recently held two (2) active Tinnitus clinical trials.

Check more hospitals offering tinnitus clinical trials below.

Top Treatments for Tinnitus Clinical Trials

There are multiple novel treatments being tested in tinnitus clinical trials, one of which is the Lenire bimodal stimulation device is a non-invasive stimulation device that is meant to relieve the symptoms of chronic subjective tinnitus. It delivers sound to the ears and connects it through a piece of mouth equipment that will give an electrical stimulus to the tongue. It was developed by Neuromod Devices Limited, which is based in Dublin, Ireland. Other treatments are also available, as listed below.

Top Cities for Tinnitus Clinical Trials

In the United States alone, Tinnitus clinical trials are being run all over the country. However, you will find more trials conducted in New York and Chicago, with a record of four (4) trials each. Portland, Louisville, and Farmington Hills are also studying alternative treatments for tinnitus, each with three (3) active trials. Check out more top cities offering tinnitus clinical trials.

Which Phases Are Most Popular For Tinnitus Clinical Trials?

According to Power's data, Phase 2 is the most popular phase when it comes to clinical trials for tinnitus. One study in Phase 2 is using OTO-313 drug for tinnitus treatment. It aims to evaluate whether the drug may help minimize the perception of the condition. See more clinical trials in varying phases of development below.

How Many Tinnitus Clinical Trials Are Open to Youth and/or Seniors?

Power gives a list of various clinical trials that are open to the youth or the senior citizens of the country. Currently, there are a total of 23 available trials for patients aged 18 and above.

Most Recent Tinnitus Clinical Trials

There are a lot of active Tinnitus clinical trials, with ebselen for vertigo currently in its 3rd phase while etanercept for tinnitus in its 2nd. The treatment group for Tinnitus, versatile, started as recently as September 15th of this month, and the trial is still recruiting participants. See more clinical trials below.

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About The Author

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 6th, 2021

Last Reviewed: October 19th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

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