NCT04069364

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 29, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

April 29, 2019

Completed
4 months until next milestone

First Posted

Study publicly available on registry

August 28, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2020

Completed
Last Updated

August 28, 2019

Status Verified

August 1, 2019

Enrollment Period

8 months

First QC Date

April 29, 2019

Last Update Submit

August 23, 2019

Conditions

Tinnitus, Subjective

Outcome Measures

Primary Outcomes (3)

  • Change of Tinnitus Handicap Inventory

    Questionnaire

    Before, after 4 months, and after 6 months

  • Change of Tinnitus Numeric Rating Scale

    Questionnaire

    Before, after 4 months, and after 6 months

  • Change Clinical Global Impression

    Questionnaire

    Before, after 4 months, and after 6 months

Secondary Outcomes (1)

  • Change of WHO Quality of Life

    Before, after 4 months, and after 6 months

Interventions

TinnitusTippsBEHAVIORAL

Self-helf tips for managing chronic tinnitus will be given via smartphones.

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • chronic tinnitus, duration at least 6 monhts

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Regensburg

Regensburg, Germany

RECRUITING

MeSH Terms

Conditions

Tinnitus

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of eHealth Group

Study Record Dates

First Submitted

April 29, 2019

First Posted

August 28, 2019

Study Start

April 29, 2019

Primary Completion

December 31, 2019

Study Completion

March 31, 2020

Last Updated

August 28, 2019

Record last verified: 2019-08

Locations

DE(1)