Impact of Meditation on Bothersome Tinnitus



Status:Active, not recruiting
Conditions:Other Indications
Therapuetic Areas:Other
Healthy:No
Age Range:18 - Any
Updated:4/6/2019
Start Date:October 6, 2018
End Date:May 1, 2020

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The purpose of this mixed methods correlational study is to investigate the effects of
meditation on the level of bother in tinnitus patients in the United States. The researchers
seek to understand the changes in bother as compared to the amount of time spent meditating.
Data is obtained through the Insight Timer mediation application. Outcome measures will
include several validated and reliable measures.

Mindfulness is a practice of "careful attention to mental and physical processes." ("Glossary
of Buddhist Terms," 2018) Mindfulness is a component of various types of spiritual practices
including meditation, specifically, from Buddhist tradition. While there are many types of
meditative activities, Western medicine has begun to focus on practices most closely related
to Vipassana Meditation, also known as, Insight Meditation. Mindfulness can be considered a
component of meditation practices, but can also be practiced and incorporated in to an
individual's daily activity.

While meditation has long been a practice in several Eastern religions and spiritual
practices, it most notably came to Europe and North America in the early 1960s. By 1976, the
Insight Meditation Society, one of the first retreat centers in the United States, was
founded by Joseph Goldstein, Sharon Salzburg, and Jack Kornfield ("Celebrating 40 Years
(1976-2016)," 2018). From this, developed the medical research around mindfulness of Jon
Kabat-Zinn, Founder of the UMass Medical School Mindfulness Based Stress Reduction (MBSR)
Program ("History of MBSR," 2017).

Mindfulness practice has gained popularity as a first line medical intervention for three
main reasons. Mindfulness practice is non-invasive, non-pharmacologic, and has no significant
side effects (Cebolla, Demarzo, Martins, Soler, & Garcia-Campayo, 2017). Since it is
non-invasive, mindfulness on its own is rarely harmful, however, if used in the place of
proven interventions can be dangerous. Those utilizing mindfulness practices and meditation
must still be under the care of appropriate medical professionals. As a non-pharmacologic
intervention, it can be cost effective and not financially prohibitive or burdensome for
patients. While the quality of instruction and subsequent practice should be further
investigated, the practice itself has the potential to be available at little cost. Much like
exercise, meditation and mindfulness practice can be subject to failure if a patient is not
compliant to the regimen. Since there is still much to know about the impacts of the types
and qualities of meditation on an individual level, its potential benefits can greatly
outweigh any risks.

For the purposes of this study meditation and meditative activities will not be limited only
to mindfulness, which can be one aspect of meditation. Meditation can be categorized into
three areas. Focused attention (FA) or concentration meditation is a practice in which the
practitioner focuses their attention on a singular idea or object (Rinpoche, 1980) as in
breath awareness, metta or loving-kindness meditation, or a repeated word or phrase as in
transcendental meditation. This has typically become a starting point for most novice
practitioners. Open-monitoring (OM) includes mindfulness practice, in which the practitioner
seeks to become aware of physical and emotional states, responses, and activities. The third
category of meditation is one that combines both Focused Attention and Open-monitoring
Meditation. This includes Vipassana practice, or Insight meditation, from which Kabat-Zinn
has developed the MBSR model. The first two practices rarely are exclusive of each other, but
rather, a practitioner's session may include FA and OM.

Previous study of meditation has demonstrated activations and changes in specific regions of
the brain. Findings from Manna et al., indicate that expert meditators control cognitive
engagement in conscious processing of sensory-related, thought and emotion contents, by
massive self-regulation of fronto-parietal and insular areas in the left hemisphere, in a
meditation state-dependent fashion. We also found that anterior cingulate and dorsolateral
prefrontal cortices play antagonist roles in the executive control of the attention setting
in meditation tasks. … Finally, our study suggests that a functional reorganization of brain
activity patterns for focused attention and cognitive monitoring takes place with mental
practice, and that meditation-related neuroplasticity is crucially associated to a functional
reorganization of activity patterns in prefrontal cortex and in the insula. (2010) Others
have confirmed through the use of fMRI that meditative methods of MBSR, Mindfulness Cognitive
Behavioral Therapy (MCBT), and dispositional mindfulness - the present moment awareness in
daily life - change functional and structural components of the prefrontal cortex, cingulate
cortex, insula, hippocampus, and amygdala after an eight-week program. These findings
indicate emotional and behavioral changes being related to those functional and structural
changes (Gotink, Meijboom, Vernooij, Smits, & Hunink, 2016). These changes were found to be
similar to those noted in experienced meditators.

Others found changes in functional connectivity in the medial prefrontal cortex, right
thalamus/parahippocampal gyrus, and bilateral anterior insula/putamen during meditation.
These findings were associated with top-down cognitive, emotion, and attention control in the
practice of mental silence in Sahaja Yoga meditation (Hernandez, Barros-Loscertales, Xiao,
Gonzalez-Mora, & Rubia, 2018).

A meta-analysis by Merkes of fifteen studies on the effects of MBSR has demonstrated improved
functional outcomes for chronic conditions including "fibromyalgia, chronic pain, rheumatoid
arthritis, type 2 diabetes, chronic fatigue syndrome, multiple chemical sensitivity, and
cardiovascular diagnoses." This analysis also reported no negative outcomes between baseline
and follow-up assessments (Merkes, 2010).

While it can be difficult to differentiate and locate the source of a patient's tinnitus, it
is thought to originate in any combination of three areas - namely peripherally from the
auditory system, centrally, or from somatosensory input. Tinnitus is commonly associated with
specific regions of the brain, particularly, the Dorsal Cochlear Nucleus, Central Auditory
Pathway, and Auditory Cortex (Han, Lee, Kim, Lim, & Shin, 2009). Most recently, using
residual inhibition, Sedley et al. found tinnitus activity in the thalamus, and contrary to
expectations, almost all of the auditory cortex and large portions of the temporal, parietal,
sensorimotor, and limbic cortex (2015).

Given tinnitus is believed to cause neuroplastic changes in several areas of the brain (Han
et al., 2009) and that meditation and mindfulness activities are shown to make restorative
changes in those same areas while improving emotional responses, this study investigates the
association between the amount of time spent and type of meditation and relief from tinnitus
through reduction of bother.

McKenna et al., have found significant reduction of bother in patients with chronic tinnitus
through the use of Mindfulness-Based Cognitive Therapy (MBCT), a standardized approach to
tinnitus management following an eight-week MBCT program led by clinical psychologists. They
rightly point out that much of the current research in non-standardized approaches, like the
one proposed in this study, has been limited by small sample sizes (2018). This study looks
to add to the body of research for non-standardized interventions and lead to the possibility
of increased access to care for patients.

Inclusion Criteria:

- Adults, age 18 and above, self-reporting bothersome tinnitus lasting longer than three
months.

- Have been evaluated by an audiologist or otologist.

- Those willing and able to utilize their own smart device or computer meeting the
following requirements. For Mac: Requires iOS 10.0 or later. Compatible with
iPhone, iPad, and iPod touch.

- For Android: varies by device.

- Data and/or Wi-Fi access

Exclusion Criteria:

- Individuals with meditation training or consistent meditation practice (practice that
totals more than 20 minutes daily) within the past six months.

- Those indicated by the Hospital Anxiety and Depression Scale to have "abnormal"
indications for anxiety or depression.

- Those with any conditions that would restrict them from being able to either sit,
walk, or lie down for at least 30 minutes at a time.
We found this trial at
1
site
Buffalo, New York 14215
Phone: 716-222-2735
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Buffalo, NY
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