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

August 23, 2019 updated by: Winfried Schlee, University Hospital Regensburg

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: SEQUENTIAL
  • Masking: SINGLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Tinnitus Handicap Inventory
Time Frame: Before, after 4 months, and after 6 months
Questionnaire
Before, after 4 months, and after 6 months
Change of Tinnitus Numeric Rating Scale
Time Frame: Before, after 4 months, and after 6 months
Questionnaire
Before, after 4 months, and after 6 months
Change Clinical Global Impression
Time Frame: Before, after 4 months, and after 6 months
Questionnaire
Before, after 4 months, and after 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of WHO Quality of Life
Time Frame: Before, after 4 months, and after 6 months
Questionnaire
Before, after 4 months, and after 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Regensburg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 29, 2019

Primary Completion (ANTICIPATED)

December 31, 2019

Study Completion (ANTICIPATED)

March 31, 2020

Study Registration Dates

First Submitted

April 29, 2019

First Submitted That Met QC Criteria

August 23, 2019

First Posted (ACTUAL)

August 28, 2019

Study Record Updates

Last Update Posted (ACTUAL)

August 28, 2019

Last Update Submitted That Met QC Criteria

August 23, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-544-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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