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

Primary Purpose

Tinnitus, Subjective

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
TinnitusTipps
Sponsored by
University Hospital Regensburg
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Tinnitus, Subjective

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of RegensburgRecruiting

Outcomes

Primary Outcome Measures

Change of Tinnitus Handicap Inventory
Questionnaire
Change of Tinnitus Numeric Rating Scale
Questionnaire
Change Clinical Global Impression
Questionnaire

Secondary Outcome Measures

Change of WHO Quality of Life
Questionnaire

Full Information

First Posted
April 29, 2019
Last Updated
August 23, 2019
Sponsor
University Hospital Regensburg
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1. Study Identification

Unique Protocol Identification Number
NCT04069364
Brief Title
Systematic Assessment of Self-help Tools for the Management of Chronic Tinnitus
Acronym
TinnitusTips
Official Title
Systematische Untersuchung Zum Einfluss Von Selbsthilfe Auf Die Subjektive Belastung Bei Chronischem Tinnitus
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 29, 2019 (Actual)
Primary Completion Date
December 31, 2019 (Anticipated)
Study Completion Date
March 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Regensburg

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinnitus, Subjective

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
TinnitusTipps
Intervention Description
Self-helf tips for managing chronic tinnitus will be given via smartphones.
Primary Outcome Measure Information:
Title
Change of Tinnitus Handicap Inventory
Description
Questionnaire
Time Frame
Before, after 4 months, and after 6 months
Title
Change of Tinnitus Numeric Rating Scale
Description
Questionnaire
Time Frame
Before, after 4 months, and after 6 months
Title
Change Clinical Global Impression
Description
Questionnaire
Time Frame
Before, after 4 months, and after 6 months
Secondary Outcome Measure Information:
Title
Change of WHO Quality of Life
Description
Questionnaire
Time Frame
Before, after 4 months, and after 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
University of Regensburg
City
Regensburg
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Winfried Schlee, PD DR
Phone
00 49 941 9412096‬
Email
winfried.schlee@tinnitusresearch.org

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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