Tinnitus is the perception of sound in the absence of an external stimulus commonly
described as ringing in the ears. Tinnitus is a highly common condition, with most
individuals experiencing it at some point in their lifetime. At least 1 in 10 US adults
experience chronic or disabling tinnitus [1] with a significant negative impact on
quality of life, often affecting sleep, concentration, mood, and hearing ability.
Tinnitus can be intermittent or constant in nature, and intensity can vary or be
exacerbated by stress, noise exposure, or other factors. Currently, there is no widely
applicable cure for tinnitus, and management typically includes use of sound therapy,
mental health counseling, lifestyle modifications, stress management, and distraction
techniques, all of which serve to mask symptoms without addressing underlying physiology.
Tinnitus is associated with changes in auditory function, with hearing loss being the
most associated co-morbidity in patients. However, tinnitus can also be observed in
patients with audiometrically normal hearing [2, 3].
Tinnitus can have a significant deleterious effect on a person's quality of life, and
there is currently no cure. State-of-the art treatment options suffer limitations and are
often ineffective and complex. Most widely used tinnitus treatments focus on reducing
awareness of tinnitus/masking symptoms and the impact on emotional state rather than
seeking to address the underlying mechanisms of the sound generation [4]. Treatment
modalities include sound therapy using environmental sounds and/or hearing aids,
psychological interventions including tinnitus retraining therapy and/or cognitive
behavioral therapy, somatosensory stimulation including vagus nerve stimulation and
osteopathic manipulation, and distraction exercises including guided breathing and
development of new hobbies. Other therapies aim to target the generation of tinnitus,
including direct and indirect stimulation of the auditory cortex and/or other brain
structures through neuromodulation and pharmacologics [5]. Despite the limited success of
many of these treatment modalities, none have been shown to be widely applicable to
manage tinnitus severity or provide a treatment for tinnitus. Further, systematic reviews
have failed to demonstrate a strong evidence base for these approaches [1]. Many
treatments and strategies currently in research are costly in terms of both time and
resources, reducing sufferers' access or their ability to continue treatment over time.
For those who do not find relief from their debilitating symptoms, and for those seeking
to address secondary effects of tinnitus, there exists a need for novel treatment aimed
at reducing acute tinnitus severity [6].
The investigators propose to show the efficacy of a highly accessible and translatable,
non-invasive device utilizing mild therapeutic hypothermia, or MTH, to reduce tinnitus
severity in participants with tinnitus. Unlike other approaches, MTH will address the
physiological mechanisms of tinnitus and is easily deployable for routine use and symptom
management. With support from a prior SBIR Phase I award, the investigators have designed
and manufactured the headband-style device, ReBoundTM, to provide therapeutic hypothermia
to the inner ear structures. Modifying temperature of the cochlea is known to influence
auditory responses [7-12]. The investigators and others have shown that MTH delivered
locally or systemically protects hearing function and cochlear structures against
noise-induced hearing loss when compared to normothermic animals [13]. The present study
builds upon strong preliminary and published results of MTH treatment in the inner ear
[14, 15] and two additional new publications [16, 17].
The goal of this interventional clinical study is to establish mild therapeutic
hypothermia, delivered non-invasively to the structures of the inner ear, as a safe and
repeatable therapeutic method for symptomatic relief of tinnitus. The study will assess
both objective and subjective measures to address two main aims:
Ascertain the benefits of mild therapeutic hypothermia for symptomatic relief of
chronic tinnitus in participants using the ReBound hypothermia device.
Ascertain the benefits of mild therapeutic hypothermia for symptom management in
chronic tinnitus participants over six months using the ReBound device.
Participants will wear the ReBound hypothermia device for 30 minutes in a single session.
Researchers will compare results from those receiving the therapy to those from a control
group (sham therapy). Participants will also use the device in-home for 6 months and
monitor their symptoms with online surveys.
This research will be highly impactful given the significant adverse effects of tinnitus,
an unmet clinical need, on a broad population, and the high translational potential of
MTH for reducing tinnitus symptoms.
