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Systematic Assessment of Self-help Tools for the Management of Chronic Tinnitus (TinnitusTips)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04069364
Recruitment Status : Recruiting
First Posted : August 28, 2019
Last Update Posted : August 28, 2019
Sponsor:
Information provided by (Responsible Party):
Winfried Schlee, University Hospital Regensburg

Brief Summary:

With this study we want to investigate the impact of self-help tools on the subjective tinnitus distress in chronic tinnitus patients.

Furthermore, we want to investigate the influence of personal characteristics on the individual tinnitus improvement.


Condition or disease Intervention/treatment Phase
Tinnitus, Subjective Behavioral: TinnitusTipps Not Applicable

Detailed Description:
A smart-phone app running on iOS devices will be used to give self-help tips to the chronic tinnitus patients.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Systematische Untersuchung Zum Einfluss Von Selbsthilfe Auf Die Subjektive Belastung Bei Chronischem Tinnitus
Actual Study Start Date : April 29, 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : March 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tinnitus


Intervention Details:
  • Behavioral: TinnitusTipps
    Self-helf tips for managing chronic tinnitus will be given via smartphones.


Primary Outcome Measures :
  1. Change of Tinnitus Handicap Inventory [ Time Frame: Before, after 4 months, and after 6 months ]
    Questionnaire

  2. Change of Tinnitus Numeric Rating Scale [ Time Frame: Before, after 4 months, and after 6 months ]
    Questionnaire

  3. Change Clinical Global Impression [ Time Frame: Before, after 4 months, and after 6 months ]
    Questionnaire


Secondary Outcome Measures :
  1. Change of WHO Quality of Life [ Time Frame: Before, after 4 months, and after 6 months ]
    Questionnaire



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:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • chronic tinnitus, duration at least 6 monhts

Exclusion Criteria:

  • acute psychosis, depression, substance abuse
  • psychopharmaca
  • epilepsy or other disease of the central nervous system
  • other tinnitus treatments in the last 3 months
  • drug, medication or alcohol abuse in the last 12 weeks

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): NCT04069364


Locations
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Germany
University of Regensburg Recruiting
Regensburg, Germany
Contact: Winfried Schlee, PD DR    00 49 941 9412096‬    winfried.schlee@tinnitusresearch.org   
Sponsors and Collaborators
University Hospital Regensburg
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Responsible Party: Winfried Schlee, Head of eHealth Group, University Hospital Regensburg
ClinicalTrials.gov Identifier: NCT04069364    
Other Study ID Numbers: 17-544-101
First Posted: August 28, 2019    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms