EMA-Defined Tinnitus Subgroups

Tinnitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02191592
• Other study ID #: 201407024
• Status: Completed
• Phase: N/A
• First received: July 14, 2014
• Last updated: March 1, 2016
• Start date: July 2014
• Est. completion date: February 2016

Study information

• Verified date: March 2016
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 2016
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 80 Years

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Tinnitus

Locations

Country	Name	City	State
United States	Washington University	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

References & Publications (6)

Axelsson A, Ringdahl A. Tinnitus--a study of its prevalence and characteristics. Br J Audiol. 1989 Feb;23(1):53-62. — View Citation

Freedman MJ, Lester KM, McNamara C, Milby JB, Schumacher JE. Cell phones for ecological momentary assessment with cocaine-addicted homeless patients in treatment. J Subst Abuse Treat. 2006 Mar;30(2):105-11. — View Citation

Meikle MB, Henry JA, Griest SE, Stewart BJ, Abrams HB, McArdle R, Myers PJ, Newman CW, Sandridge S, Turk DC, Folmer RL, Frederick EJ, House JW, Jacobson GP, Kinney SE, Martin WH, Nagler SM, Reich GE, Searchfield G, Sweetow R, Vernon JA. The tinnitus functional index: development of a new clinical measure for chronic, intrusive tinnitus. Ear Hear. 2012 Mar-Apr;33(2):153-76. doi: 10.1097/AUD.0b013e31822f67c0. Erratum in: Ear Hear. 2012 May;33(3):443. — View Citation

Shiffman S, Stone AA, Hufford MR. Ecological momentary assessment. Annu Rev Clin Psychol. 2008;4:1-32. Review. — View Citation

Stone AA, Schwartz JE, Broderick JE, Shiffman SS. Variability of momentary pain predicts recall of weekly pain: a consequence of the peak (or salience) memory heuristic. Pers Soc Psychol Bull. 2005 Oct;31(10):1340-6. — View Citation

Stone AA, Shiffman S. Capturing momentary, self-report data: a proposal for reporting guidelines. Ann Behav Med. 2002 Summer;24(3):236-43. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ecological Momentary Assessment of Tinnitus	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.	Week 1-2 and Week 4-6	No
Secondary	Tinnitus Functional Index (TFI)	This is a retrospective patient self-report questionnaire. It scores the severity of patient bother experienced from their tinnitus.	Pre-Screening, Baseline, Week 2, Week 4, Week 6	No

External Links

•   Clinical Outcomes Research Office Web-site
•   Link to the pre-screening survey