- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02191592
EMA-Defined Tinnitus Subgroups
Identification of Unique Tinnitus Subgroups Using Ecological Momentary Assessment (EMA).
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.
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Missouri
-
St. Louis, Missouri, United States, 63110
- Washington University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Week 1-2 and Week 4-6
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Pre-Screening, Baseline, Week 2, Week 4, Week 6
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Shiffman S, Stone AA, Hufford MR. Ecological momentary assessment. Annu Rev Clin Psychol. 2008;4:1-32. doi: 10.1146/annurev.clinpsy.3.022806.091415.
- 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.
- Stone AA, Shiffman S. Capturing momentary, self-report data: a proposal for reporting guidelines. Ann Behav Med. 2002 Summer;24(3):236-43. doi: 10.1207/S15324796ABM2403_09.
- 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. doi: 10.1016/j.jsat.2005.10.005.
- 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. doi: 10.1177/0146167205275615.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201407024
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Tinnitus
-
State University of New York at BuffaloUniversity at BuffaloCompletedTinnitus, Subjective | Tinnitus | Noise Induced Tinnitus | Tinnitus, Objective | Tinnitus Aggravated | Tinnitus, Pulsatile | Tinnitus, Spontaneous Oto-Acoustic Emission | Tinnitus, Clicking | Tinnitus, Tensor Tympani InducedUnited States
-
Mohab MohammedNot yet recruitingPulsatile Tinnitus (Diagnosis)
-
Philipps University Marburg Medical CenterLinkoeping University; Eriksholm Research Centre; University Hospital of Gießen...CompletedTinnitus | Subjective Tinnitus | Chronic TinnitusGermany
-
University of GuadalajaraHospital Civil de Guadalajara; Institute of Experimental and Clinical TherapeuticsRecruitingOxidative Stress | Tinnitus, Subjective | Tinnitus, Bilateral | Antioxidant Therapy | Psychiatric Drugs | Inflammatory Cytokines | SSRIMexico
-
University Hospital, BordeauxNot yet recruiting
-
Cairo UniversityRecruiting
-
University of ZurichRecruitingTinnitus, Subjective | TinnitusSwitzerland
-
Eye & ENT Hospital of Fudan UniversityNot yet recruiting
-
University of Illinois at Urbana-ChampaignGN Hearing A/SActive, not recruitingTinnitus, SubjectiveUnited States
-
University of ZurichCompletedTinnitus, SubjectiveGermany, Switzerland