Impact of Meditation on Bothersome Tinnitus

• ClinicalTrials.gov Identifier: NCT03711630
• Recruitment Status: Completed
• First Posted: October 18, 2018
• Last Update Posted: October 22, 2020
• Sponsor: State University of New York at Buffalo
• Collaborator: University at Buffalo
• Information provided by (Responsible Party): Brendan P. Fitzgerald, State University of New York at Buffalo

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Tinnitus; Noise Induced Tinnitus; Tinnitus, Subjective; Tinnitus, Objective; Tinnitus Aggravated; Tinnitus, Pulsatile; Tinnitus, Spontaneous Oto-Acoustic Emission; Tinnitus, Clicking; Tinnitus, Tensor Tympani Induced	Behavioral: Meditation	Not Applicable

Detailed Description:

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 27 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: This study is a non-randomized interventional study in which subjects with bothersome tinnitus will meditate to investigate how meditation effects the level of bother of their tinnitus.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Impact of Meditation on Bothersome Tinnitus
• Actual Study Start Date: October 6, 2018
• Actual Primary Completion Date: February 23, 2019
• Actual Study Completion Date: March 21, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: Meditation; The study cohort will participate in self-guided meditation practice over the course of eight weeks.	Behavioral: Meditation; Meditation practice will be through the InsightTimer smart device application. Participants will choose what types of meditation practices they will engage in and report their time spent meditating via REDCap.

Outcome Measures

Primary Outcome Measures :

1. Tinnitus Handicap Questionnaire (Change in Bother from Tinnitus Over Time) [ Time Frame: Week 1, Week 3, Week 8 ]
   A measure of degree of bother imposed by tinnitus on the patient.

Secondary Outcome Measures :

1. Tinnitus Handicap Inventory [ Time Frame: Week 1, Week 3, Week 8 ]
   A measure of degree of bother imposed by tinnitus on the patient.
2. Hospital Anxiety and Depression Scale [ Time Frame: Week 1, Week 3, Week 8 ]

   A scale to determine the degree and impact of a participant's anxiety and depression.

   Scoring:

   Total score: Depression (D) ___________ Anxiety (A) ______________ 0-7 = Normal 8-10 = Borderline abnormal (borderline case) 11-21 = Abnormal (case) 16-21 = exclusionary for participation in this study

3. Tinnitus Functional Index [ Time Frame: Week 1, Week 3, Week 8 ]
   A measure of degree of bother imposed by tinnitus on the patient.
4. Mindful Attention Awareness Scale [ Time Frame: Week 1, Week 3, Week 8 ]

   A measure to determine the degree of mindful attention the participant utilizes in their lives during the course of the study.

   To score the scale, simply compute a mean of the 15 items. Higher scores reflect higher levels of dispositional mindfulness.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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.

Contacts and Locations

Locations

United States, New York

University at Buffalo

Buffalo, New York, United States, 14226

Sponsors and Collaborators

State University of New York at Buffalo

University at Buffalo

  Study Documents (Full-Text)

Documents provided by Brendan P. Fitzgerald, State University of New York at Buffalo:

Study Protocol  [PDF] September 7, 2018

More Information

Publications:

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• Responsible Party: Brendan P. Fitzgerald, Principal Investigator, State University of New York at Buffalo
• ClinicalTrials.gov Identifier: NCT03711630
• Other Study ID Numbers: STUDY00002602
• First Posted: October 18, 2018
• Last Update Posted: October 22, 2020
• Last Verified: October 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: This study will not share IPD beyond authors within this study.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Tinnitus; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases