EMA-Defined Tinnitus Subgroups
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|ClinicalTrials.gov Identifier: NCT02191592|
Recruitment Status : Completed
First Posted : July 16, 2014
Last Update Posted : March 2, 2016
The purpose of this research study is to test a new way of measuring the severity of tinnitus using a tool called Ecological Momentary Assessment (EMA) of Tinnitus. We will compare the relationship with this tool with another widely used questionnaire. Previous studies we have done suggest there are different patterns of tinnitus bother; we plan to explore how often these patterns occur, and how many patterns of tinnitus bother there are. And lastly we want to test how reliable this type of testing is for measuring the amount of bother people experience from their tinnitus.
Hypothesis 1: We will be able to identify 6 or more distinctive patterns of tinnitus.
Hypothesis 2: EMA will provide a reliable method for more accurately capturing the amount of bother individuals have from tinnitus.
|Condition or disease|
You to need to complete this brief survey to determine if you meet the criteria for participation in the study. You are free to skip any questions that you prefer not to answer. We will only use the information you provide in this survey to determine if you qualify for the EMA-Defined Tinnitus Subgroups study.
To be in this study, you will be required to have a smart phone that can receive text messages, is connected to the internet, and will allow you to connect via the internet to a Washington University secure server. It is necessary to connect to the Washington University server in order to complete a short survey four times a day for two separate two-week periods.
The study involves us sending you text messages at 4 random times during the day, between the hours of 8: 00 am - 9: 00 pm. The texts prompt you to click on a link and respond to a short EMA survey regarding what you are doing, what your environment is, and how your tinnitus is at that moment. These text messages will be sent daily for two weeks. Then you will have two weeks off. Finally you will again receive the text messages asking for you to respond to the survey for two more weeks. You will receive a total of 112 text messages over four weeks. In addition we will send you four emails or texts asking you to complete a survey at the following times: before you complete your first set of EMA surveys, at the end of the first set EMA surveys, prior to starting the second set of EMA surveys, and a final time after you have completed the final EMA survey. This study requires no visits to Washington University.
In order to participate you must complete this short prescreening survey to see if you qualify.
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||40 participants|
|Target Follow-Up Duration:||6 Weeks|
|Official Title:||Identification of Unique Tinnitus Subgroups Using Ecological Momentary Assessment (EMA).|
|Study Start Date :||July 2014|
|Actual Primary Completion Date :||July 2015|
|Actual Study Completion Date :||February 2016|
- Ecological Momentary Assessment of Tinnitus [ Time Frame: Week 1-2 and Week 4-6 ]This is a two week period of capturing real time data regarding a subjects tinnitus bother, environment, and activity at random periods of the day. This is a patient self report measure, but captures data in real time vs. asking them to recall information retrospectively.
- Tinnitus Functional Index (TFI) [ Time Frame: Pre-Screening, Baseline, Week 2, Week 4, Week 6 ]This is a retrospective patient self-report questionnaire. It scores the severity of patient bother experienced from their tinnitus.
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): NCT02191592
|United States, Missouri|
|St. Louis, Missouri, United States, 63110|