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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
Sponsor:
Information provided by (Responsible Party):
Jay F. Piccirillo, MD, Washington University School of Medicine

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.


Condition or disease
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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 40 participants
Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tinnitus




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects will be recruited from Otolaryngology Clinics and from Tinnitus Support Groups
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.

Information from the National Library of Medicine

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


Locations
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United States, Missouri
Washington University
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Additional Information:
Publications:
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Responsible Party: Jay F. Piccirillo, MD, Professor, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02191592    
Other Study ID Numbers: 201407024
First Posted: July 16, 2014    Key Record Dates
Last Update Posted: March 2, 2016
Last Verified: March 2016
Keywords provided by Jay F. Piccirillo, MD, Washington University School of Medicine:
Tinnitus
EMA
Bothersome
Additional relevant MeSH terms:
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Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases