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

Not Applicable

• Conditions: Tinnitus, Subjective

• Registration Number: NCT04069364
• Lead Sponsor: 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.

Detailed Description

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

Study Timeline

• Study Start: 2019-04-29
• Study First Submitted: 2019-04-29
• Status Verified: 2019-08
• Study First Submitted QC: 2019-08-23
• Last Update Submitted: 2019-08-23
• Study First Posted: 2019-08-28
• Last Update Posted: 2019-08-28
• Primary Completion: 2019-12-31
• Study Completion: 2020-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Change of Tinnitus Numeric Rating Scale	Before, after 4 months, and after 6 months	Questionnaire
Change of Tinnitus Handicap Inventory	Before, after 4 months, and after 6 months	Questionnaire
Change Clinical Global Impression	Before, after 4 months, and after 6 months	Questionnaire

Secondary Outcome Measures

Name	Time	Method
Change of WHO Quality of Life	Before, after 4 months, and after 6 months	Questionnaire

Trial Locations

Locations (1)

University of Regensburg; 🇩🇪 Regensburg, Germany