Systematic Assessment of Self-help Tools for the Manageme... | NCT04069364

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

NCT04069364

Sponsor

University Hospital Regensburg

Status

Unknown status

Last Update Posted

Aug 28, 2019Actual

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Tinnitus, Subjective

Interventions

TinnitusTipps

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 29, 2019Actual

Primary Completion Date

Dec 31, 2019Estimated

Completion Date

Mar 31, 2020Estimated

First Submitted Date

Apr 29, 2019

First Submission Date that Met QC Criteria

Aug 23, 2019

First Posted Date

Aug 28, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 23, 2019

Last Update Posted Date

Aug 28, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Winfried Schlee, Head of eHealth Group, University Hospital RegensburgPrincipal Investigator

Lead Sponsor

University Hospital RegensburgOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
TinnitusTipps	Behavioral	Self-helf tips for managing chronic tinnitus will be given via smartphones.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Regensburg	Recruiting	Regensburg			Germany

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D014012	Tinnitus

Ancestor Terms

ID	Term
D006311	Hearing Disorders
D004427	Ear Diseases
D010038	Otorhinolaryngologic Diseases
D012678	Sensation Disorders

Browse Leaves

Not provided

Browse Branches

Not provided