Impact of Meditation on Bothersome Tinnitus

NCT03711630 | Completed

• 1 other identifier: STUDY00002602
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Tinnitus; Noise Induced Tinnitus; Tinnitus, Subjective; Tinnitus, Objective; Tinnitus Aggravated; Tinnitus, Pulsatile; Tinnitus, Spontaneous Oto-Acoustic Emission; Tinnitus, Clicking; Tinnitus, Tensor Tympani Induced

Outcome Measures

Primary Outcomes (1)

• Tinnitus Handicap Questionnaire (Change in Bother from Tinnitus Over Time)

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

  Week 1, Week 3, Week 8

Secondary Outcomes (4)

• Tinnitus Handicap Inventory

  Week 1, Week 3, Week 8

• Hospital Anxiety and Depression Scale

  Week 1, Week 3, Week 8

• Tinnitus Functional Index

  Week 1, Week 3, Week 8

• Mindful Attention Awareness Scale

  Week 1, Week 3, Week 8

Study Arms (1)

Meditation

EXPERIMENTAL

The study cohort will participate in self-guided meditation practice over the course of eight weeks.

Behavioral: Meditation

Interventions

Meditation BEHAVIORAL

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.

Meditation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• State University of New York at Buffalo: lead
• University at Buffalo: collaborator

Study Sites (1)

University at Buffalo

Buffalo, New York, 14226, United States

Location

Related Publications (31)

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MeSH Terms

Conditions

Tinnitus

Interventions

Meditation

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Relaxation Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: October 9, 2018
• First Posted: October 18, 2018
• Study Start: October 6, 2018
• Primary Completion: February 23, 2019
• Study Completion: March 21, 2020
• Last Updated: October 22, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)