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Impact of Meditation on Bothersome Tinnitus

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ClinicalTrials.gov Identifier: NCT03711630
Recruitment Status : Active, not recruiting
First Posted : October 18, 2018
Last Update Posted : April 5, 2019
Sponsor:
Collaborator:
University at Buffalo
Information provided by (Responsible Party):
State University of New York at Buffalo

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

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
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
Estimated Study Completion Date : May 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tinnitus

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.




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.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03711630


Locations
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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 State University of New York at Buffalo:
Study Protocol  [PDF] September 7, 2018


Publications:
National Health and Nutrition Examination Survey. (2013). Retrieved from https://wwwn.cdc.gov/nchs/nhanes/2011-2012/AUQ_G.htm.
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
Merkes, M. (2010). Mindfulness-based stress reduction for people with chronic diseases. Available from NLM Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews, from York (UK): Centre for Reviews and Dissemination (UK)

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Responsible Party: State University of New York at Buffalo
ClinicalTrials.gov Identifier: NCT03711630     History of Changes
Other Study ID Numbers: STUDY00002602
First Posted: October 18, 2018    Key Record Dates
Last Update Posted: April 5, 2019
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: It has yet to be determined following IRB review if this study will share its data with other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms