Clinical trial NCT02191592: EMA-Defined Tinnitus Subgroups
Official title: Identification of Unique Tinnitus Subgroups Using Ecological Momentary Assessment (EMA).
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tinnitus
Keywords: Tinnitus
EMA
Bothersome
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2014-07-16
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be recruited from Otolaryngology Clinics and from Tinnitus Support Groups

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Age between the ages of 21 and 80.
* Have subjective, unilateral or bilateral, tinnitus of 6 months' duration or longer.
* Must be score of 1, 2, 3, or 4 on Global Bother Score. (Range is 0-4, with 0 being not bothered and 4 being extremely bothered)
* Must have access to a smart phone device compatible with the notification system.
* Must be able to read, write, and understand English.

Exclusion Criteria:

* Tinnitus related to Workman's Compensation Claim or other litigation-related situations.

Primary outcomes:
measure: Ecological Momentary Assessment of Tinnitus
timeFrame: Week 1-2 and Week 4-6
Secondary outcomes:
measure: Tinnitus Functional Index (TFI)
timeFrame: Pre-Screening, Baseline, Week 2, Week 4, Week 6
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Washington University
state: Missouri
Study officials:
References:
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citation: Axelsson A, Ringdahl A. Tinnitus--a study of its prevalence and characteristics. Br J Audiol. 1989 Feb;23(1):53-62. doi: 10.3109/03005368909077819.