New Therapy for Patients With Severe Tinnitus
| Status: | Completed |
|---|---|
| Conditions: | Other Indications |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 6/1/2017 |
| Start Date: | September 2011 |
| End Date: | November 2013 |
Preliminary Clinical Trial of an Integrative Therapy With Severe Tinnitus
Tinnitus is a common problem for which there is no universally effective treatment. The best
available estimates indicate that 10 - 15% of adults report having tinnitus symptoms, but
only 20% of those who report tinnitus suffer from it and subsequently seek treatment. Only
formally reported by the U.S. Department of Veterans Affairs (VA), the economic impact of
tinnitus is thought to be substantial. The VA reported in 2004 that 289,159 veterans
received a disability award for their tinnitus amounting to a total annual compensation
amount of over $345.5 million. Individuals with persistent severe tinnitus are unable to
habituate to the tinnitus sound that most likely originates in the central auditory system
(CAS) in response to peripheral injury. In a widely referenced study, it has been
hypothesized that lack of habituation is secondary to abnormal processing of sensory
information. Specifically, processing by the limbic system and autonomic nervous system is
apparently abnormal in patients with increased levels of cortical arousal and inadequate
coping mechanisms. In otolaryngology and audiology clinics, 'sound-based and educational
therapies' (SBE) are the focus of most current therapies, and utilize enhanced sound input
to the CAS. While SBE treatments may well provide a starting point for tinnitus treatment,
additional treatment options are necessary particularly for those with significant
non-auditory aspects of tinnitus (e.g., anxiety, depression, interference with daily life)
as well as for those who do not experience significant improvement with SBE. Furthermore,
commonly used forms of SBE [e.g.,Tinnitus Retraining Therapy (TRT)] can require over a year
to become effective and may not be used in patients with hearing that is too poor to be
modified by sound input. Based on prevalence data from tinnitus sufferers who seek treatment
and the known percentage who do not respond to commonly used therapies, we estimate that 1.2
million individuals are not able to benefit at all from current, widely used treatment
strategies. A new strategy to augment those currently used could empower patients to exert
control over their tinnitus symptoms without the use of medications, expensive devices such
as the Neuromonics device, or extended programs such as TRT. An alternative strategy may be
useful both for patients who are not candidates for SBE and for those who respond poorly. An
Integrative Medicine approach provides a likely solution. To date, there has been no
systematic study of the benefits of an Integrative Medicine approach for severe tinnitus,
particularly for non-auditory aspects of tinnitus symptoms. The goal of the proposed study
is to determine if an integrative medicine approach which targets treatment of the
nonauditory aspects of tinnitus suffering is more effective in alleviating tinnitus symptoms
when added to current commonly applied SBE therapies, compared with SBE alone. If
successful, this approach will be applied to a larger patient population in future studies
to test the generalizability and the durability of the effect. Our eventual goal is to
develop a streamlined approach that individualizes tinnitus treatment based on symptoms and
patient characteristics, and that can be widely applied in general medical practice.
available estimates indicate that 10 - 15% of adults report having tinnitus symptoms, but
only 20% of those who report tinnitus suffer from it and subsequently seek treatment. Only
formally reported by the U.S. Department of Veterans Affairs (VA), the economic impact of
tinnitus is thought to be substantial. The VA reported in 2004 that 289,159 veterans
received a disability award for their tinnitus amounting to a total annual compensation
amount of over $345.5 million. Individuals with persistent severe tinnitus are unable to
habituate to the tinnitus sound that most likely originates in the central auditory system
(CAS) in response to peripheral injury. In a widely referenced study, it has been
hypothesized that lack of habituation is secondary to abnormal processing of sensory
information. Specifically, processing by the limbic system and autonomic nervous system is
apparently abnormal in patients with increased levels of cortical arousal and inadequate
coping mechanisms. In otolaryngology and audiology clinics, 'sound-based and educational
therapies' (SBE) are the focus of most current therapies, and utilize enhanced sound input
to the CAS. While SBE treatments may well provide a starting point for tinnitus treatment,
additional treatment options are necessary particularly for those with significant
non-auditory aspects of tinnitus (e.g., anxiety, depression, interference with daily life)
as well as for those who do not experience significant improvement with SBE. Furthermore,
commonly used forms of SBE [e.g.,Tinnitus Retraining Therapy (TRT)] can require over a year
to become effective and may not be used in patients with hearing that is too poor to be
modified by sound input. Based on prevalence data from tinnitus sufferers who seek treatment
and the known percentage who do not respond to commonly used therapies, we estimate that 1.2
million individuals are not able to benefit at all from current, widely used treatment
strategies. A new strategy to augment those currently used could empower patients to exert
control over their tinnitus symptoms without the use of medications, expensive devices such
as the Neuromonics device, or extended programs such as TRT. An alternative strategy may be
useful both for patients who are not candidates for SBE and for those who respond poorly. An
Integrative Medicine approach provides a likely solution. To date, there has been no
systematic study of the benefits of an Integrative Medicine approach for severe tinnitus,
particularly for non-auditory aspects of tinnitus symptoms. The goal of the proposed study
is to determine if an integrative medicine approach which targets treatment of the
nonauditory aspects of tinnitus suffering is more effective in alleviating tinnitus symptoms
when added to current commonly applied SBE therapies, compared with SBE alone. If
successful, this approach will be applied to a larger patient population in future studies
to test the generalizability and the durability of the effect. Our eventual goal is to
develop a streamlined approach that individualizes tinnitus treatment based on symptoms and
patient characteristics, and that can be widely applied in general medical practice.
Inclusion Criteria:
1. Debilitating tinnitus, defined by score on the Tinnitus Hearing Inventory > 38;
2. Participation not ruled out by baseline medical exam (see below);
3. Age 18 or older (no upper age limit);
4. No acute systemic illness requiring frequent treatment such as chemotherapy,
dialysis, and no such treatment in the past 3 months,
5. Able to speak, read and write in English,
6. Willingness to participate fully in either treatment arm when randomized,
7. Not currently enrolled in another clinical trial or taking an experimental
8. No previous experience with either Sound Based and Educational (SBE) therapies as
applied in this study or an Integrated Medicine approach specifically for the
treatment of tinnitus symptoms; and
9. Adequate hearing to allow participation in the SBE treatment program.
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