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TinnitusNCT03711630

Impact of Meditation on Bothersome Tinnitus

A study testing Meditation in people with Tinnitus and Noise Induced Tinnitus, run by State University of New York at Buffalo at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Meditation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
1 siteUnited States
Study dates
6 Oct 2018to 21 Mar 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University at Buffalo

    Buffalo, New York, 14226

Other trials in United States

About this study

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.

Read the 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.

Being tested
Meditation
Medical subject headings
Tinnitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MeditationBehavioural

    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.

Study groups in NCT03711630
Study groupRoleWhat they receive
MeditationExperimentalThe study cohort will participate in self-guided meditation practice over the course of eight weeks.
Receives: Behavioral: Meditation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Tinnitus Handicap Questionnaire (Change in Bother from Tinnitus Over Time)

    A measure of degree of bother imposed by tinnitus on the patient.

    Measured: Week 1, Week 3, Week 8

Secondary outcomes (4)
  1. Tinnitus Handicap Inventory

    A measure of degree of bother imposed by tinnitus on the patient.

    Measured: Week 1, Week 3, Week 8

  2. Hospital Anxiety and Depression Scale

    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

    Measured: Week 1, Week 3, Week 8

  3. Tinnitus Functional Index

    A measure of degree of bother imposed by tinnitus on the patient.

    Measured: Week 1, Week 3, Week 8

  4. Mindful Attention Awareness Scale

    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.

    Measured: Week 1, Week 3, Week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Oct 2018
  2. Study start6 Oct 2018
  3. Primary completion23 Feb 2019
  4. Study completion21 Mar 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
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)
Enrolment
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03711630
Sponsor's protocol ID
STUDY00002602
Status last verified
Oct 2020
First submitted
9 Oct 2018
Last updated
22 Oct 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: This study will not share IPD beyond authors within this study.

Publications

  • National Health and Nutrition Examination Survey. (2013). Retrieved from https://wwwn.cdc.gov/nchs/nhanes/2011-2012/AUQ_G.htm.

  • Alsubaie M, Abbott R, Dunn B, Dickens C, Keil TF, Henley W, Kuyken W. Mechanisms of action in mindfulness-based cognitive therapy (MBCT) and mindfulness-based stress reduction (MBSR) in people with physical and/or psychological conditions: A systematic review. Clin Psychol Rev. 2017 Jul;55:74-91. doi: 10.1016/j.cpr.2017.04.008. Epub 2017 Apr 23.

    PubMed 28501707
  • Anheyer D, Haller H, Barth J, Lauche R, Dobos G, Cramer H. Mindfulness-Based Stress Reduction for Treating Low Back Pain: A Systematic Review and Meta-analysis. Ann Intern Med. 2017 Jun 6;166(11):799-807. doi: 10.7326/M16-1997. Epub 2017 Apr 25.

    PubMed 28437793
  • Bhatt JM, Lin HW, Bhattacharyya N. Prevalence, Severity, Exposures, and Treatment Patterns of Tinnitus in the United States. JAMA Otolaryngol Head Neck Surg. 2016 Oct 1;142(10):959-965. doi: 10.1001/jamaoto.2016.1700.

    PubMed 27441392
  • Candia V, Wienbruch C, Elbert T, Rockstroh B, Ray W. Effective behavioral treatment of focal hand dystonia in musicians alters somatosensory cortical organization. Proc Natl Acad Sci U S A. 2003 Jun 24;100(13):7942-6. doi: 10.1073/pnas.1231193100. Epub 2003 May 27.

    PubMed 12771383
  • Cebolla A, Demarzo M, Martins P, Soler J, Garcia-Campayo J. Unwanted effects: Is there a negative side of meditation? A multicentre survey. PLoS One. 2017 Sep 5;12(9):e0183137. doi: 10.1371/journal.pone.0183137. eCollection 2017.

    PubMed 28873417
  • Chou R, Deyo R, Friedly J, Skelly A, Hashimoto R, Weimer M, Fu R, Dana T, Kraegel P, Griffin J, Grusing S, Brodt ED. Nonpharmacologic Therapies for Low Back Pain: A Systematic Review for an American College of Physicians Clinical Practice Guideline. Ann Intern Med. 2017 Apr 4;166(7):493-505. doi: 10.7326/M16-2459. Epub 2017 Feb 14.

    PubMed 28192793
  • Gans, J. J., O'Sullivan, P., & Bircheff, V. (2014). Mindfulness Based Tinnitus Stress Reduction Pilot Study A Symptom Perception-Shift Program. Mindfulness, 5(3), 322-333. doi:10.1007/s12671-012-0184-4

  • Goldin P, Ramel W, Gross J. Mindfulness Meditation Training and Self-Referential Processing in Social Anxiety Disorder: Behavioral and Neural Effects. J Cogn Psychother. 2009 Aug;23(3):242-257. doi: 10.1891/0889-8391.23.3.242.

    PubMed 25568592
  • Gotink RA, Meijboom R, Vernooij MW, Smits M, Hunink MG. 8-week Mindfulness Based Stress Reduction induces brain changes similar to traditional long-term meditation practice - A systematic review. Brain Cogn. 2016 Oct;108:32-41. doi: 10.1016/j.bandc.2016.07.001. Epub 2016 Jul 16.

    PubMed 27429096
  • Gotink RA, Younge JO, Wery MF, Utens EMWJ, Michels M, Rizopoulos D, van Rossum LFC, Roos-Hesselink JW, Hunink MMG. Online mindfulness as a promising method to improve exercise capacity in heart disease: 12-month follow-up of a randomized controlled trial. PLoS One. 2017 May 9;12(5):e0175923. doi: 10.1371/journal.pone.0175923. eCollection 2017.

    PubMed 28486559
  • Han BI, Lee HW, Kim TY, Lim JS, Shin KS. Tinnitus: characteristics, causes, mechanisms, and treatments. J Clin Neurol. 2009 Mar;5(1):11-9. doi: 10.3988/jcn.2009.5.1.11. Epub 2009 Mar 31.

    PubMed 19513328
  • Henry JA, Zaugg TL, Myers PJ, Schechter MA. The role of audiologic evaluation in progressive audiologic tinnitus management. Trends Amplif. 2008 Sep;12(3):170-87. doi: 10.1177/1084713808319941. Epub 2008 Jul 15.

    PubMed 18628281
  • Henry JA, Zaugg TL, Schechter MA. Clinical guide for audiologic tinnitus management I: Assessment. Am J Audiol. 2005 Jun;14(1):21-48. doi: 10.1044/1059-0889(2005/004).

    PubMed 16180968
  • Hernandez SE, Barros-Loscertales A, Xiao Y, Gonzalez-Mora JL, Rubia K. Gray Matter and Functional Connectivity in Anterior Cingulate Cortex are Associated with the State of Mental Silence During Sahaja Yoga Meditation. Neuroscience. 2018 Feb 10;371:395-406. doi: 10.1016/j.neuroscience.2017.12.017. Epub 2017 Dec 22.

    PubMed 29275207

Questions about this trial

What is this clinical trial studying?

A study testing Meditation in people with Tinnitus and Noise Induced Tinnitus, run by State University of New York at Buffalo at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tinnitus Handicap Questionnaire (Change in Bother from Tinnitus Over Time) (time frame: Week 1, Week 3, Week 8). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03711630, which also lists 31 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2020.

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