NCT04069364UnknownNot Applicable
Systematische Untersuchung Zum Einfluss Von Selbsthilfe Auf Die Subjektive Belastung Bei Chronischem Tinnitus
University Hospital Regensburg1 site in 1 country50 target enrollmentStarted: April 29, 2019Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Change of Tinnitus Numeric Rating Scale
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Supportive Care
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Change of Tinnitus Numeric Rating Scale
Time Frame: Before, after 4 months, and after 6 months
Questionnaire
Change of Tinnitus Handicap Inventory
Time Frame: Before, after 4 months, and after 6 months
Questionnaire
Change Clinical Global Impression
Time Frame: Before, after 4 months, and after 6 months
Questionnaire
Secondary Outcomes
- Change of WHO Quality of Life(Before, after 4 months, and after 6 months)
Investigators
Winfried Schlee
Head of eHealth Group
University Hospital Regensburg
Study Sites (1)
Loading locations...
Similar Trials
Completed
Not Applicable
Self-efficacy-based Auditory Rehabilitation With Over-the-Counter Hearing AidsHearing Loss, SensorineuralNCT06560918University of Arkansas5
Completed
Not Applicable
Impact of Hearing Aid Technology on Self-reported OutcomesPresbycusis, BilateralNCT04539847University of Southern Denmark208
Completed
Not Applicable
Evaluation of the OtoBand in Subjects With Self-reported Vertigo to Reduce Severity of Vertigo in a Real-world SettingVertigoNCT04869020Otolith Labs40
Completed
Not Applicable
Self Fitting Hearing Aid Clinical InvestigationHearing Loss, SensorineuralNCT05612763Starkey Laboratories, Inc40
Completed
Not Applicable
Evaluation of Self-management Education in First Time Hearing Aid UsersHearing LossNCT03912779Nottingham University Hospitals NHS Trust56