Impact of Meditation on Bothersome Tinnitus
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03711630|
Recruitment Status : Active, not recruiting
First Posted : October 18, 2018
Last Update Posted : April 5, 2019
|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
|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)|
|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|
The study cohort will participate in self-guided meditation practice over the course of eight weeks.
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.
- 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.
- Tinnitus Handicap Inventory [ Time Frame: Week 1, Week 3, Week 8 ]A measure of degree of bother imposed by tinnitus on the patient.
- 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.
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
- Tinnitus Functional Index [ Time Frame: Week 1, Week 3, Week 8 ]A measure of degree of bother imposed by tinnitus on the patient.
- 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.
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
|United States, New York|
|University at Buffalo|
|Buffalo, New York, United States, 14226|