EMA-Defined Tinnitus Subgroups

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.

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Key information

Conditions

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

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Washington University

St Louis, Missouri, 63110, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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.

Secondary outcomes

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.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

Identification of Unique Tinnitus Subgroups Using Ecological Momentary Assessment (EMA).

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2016
First posted: Jul 16, 2014
Registry last updated: Mar 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed