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NCT04069364 Clinical Trial

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

Tinnitus, Subjective Clinical Trial

— TinnitusTips  

Official title:
Systematische Untersuchung Zum Einfluss Von Selbsthilfe Auf Die Subjektive Belastung Bei Chronischem Tinnitus

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04069364
Other study ID # 17-544-101
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 29, 2019
Est. completion date March 31, 2020

Study information
Verified date August 2019
Source University Hospital Regensburg
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility
Status Recruiting
Enrollment 50
Est. completion date March 31, 2020
Est. primary completion date December 31, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Germany University of Regensburg Regensburg

Sponsors (1)
Lead Sponsor Collaborator
University Hospital Regensburg

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change of Tinnitus Handicap Inventory Questionnaire Before, after 4 months, and after 6 months
Primary Change of Tinnitus Numeric Rating Scale Questionnaire Before, after 4 months, and after 6 months
Primary Change Clinical Global Impression Questionnaire Before, after 4 months, and after 6 months
Secondary Change of WHO Quality of Life Questionnaire Before, after 4 months, and after 6 months
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