Research Project About Psychological Strain, Quality of L... | NCT01837368

Studies
Research Project About Psychological Strain, Quality of Life and Emotional Awareness in Patients With Tinnitus

NCT01837368

Sponsor

University of Zurich

Status

Completed

Last Update Posted

May 10, 2016Estimated

Enrollment

250Actual

Phase

Not provided

Conditions

Tinnitus

Interventions

observational research

Countries

Switzerland

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

May 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2012

Primary Completion Date

May 2016Actual

Completion Date

May 2016Actual

First Submitted Date

Dec 19, 2012

First Submission Date that Met QC Criteria

Apr 22, 2013

First Posted Date

Apr 23, 2013Estimated

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

May 9, 2016

Last Update Posted Date

May 10, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

Validation of PRISM (Pictorial Representation of Illness and Self Measure) as a assessment of quality of life and suffering in patients with tinnitus.

Association between experiencing, verbalizing and regulating emotions and perceived tinnitus.

Correlation analysis are used to search for connections between the subjective behavioral outcomes mentioned above and the objective EEG-patterns.

Detailed Description

Validation of PRISM (Pictorial Representation of Illness and Self Measure). Assessment of quality of life and suffering in patients with tinnitus in an observational study using different questionnaires. (THI, TF, TBF-12, BDI, BAI, SF-36).

THI - Tinnitus Handicap Inventory

TF - Tinnitus Questionnaire after Goebel and Hiller

TBF-12 - Tinnitus Impairment Questionnaire

BDI - Beck Depression Inventory

BAI - Beck Anxiety Inventory

SF-36 - Short Form 36 Health Survey Questionnaire

Association between experiencing, verbalizing and regulating emotions and perceived tinnitus using the TAS-20 (20-Item Toronto Alexithymia Scale) and the above mentioned questionnaires.

EEG-studies on the spontaneous brain activity of individuals affected by tinnitus consistently report differences in the composition of the EEG-frequency spectrum between individuals with tinnitus and healthy controls. Furthermore it has been shown that not only the auditory cortex but other regions of the brain are involved in the perception of the chronic ear noise as well. Among them is the limbic system which is associated with the emotional processing of the human brain.

Correlation analysis are used to search for connections between the subjective behavioral outcomes mentioned above and the objective EEG-patterns. Aim of the current study is to provide conclusive models of associated assessments of the psychological strain end emotional stress of individuals suffering from tinnitus and objective EEG-analysis.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

250Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
observational research	Other	It is a observational research, no intervention are performed

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Values of PRISM	measures the burden of suffering	4 weeks
TAS	Alexithymia- measured with TAS-toronto alexithymia scale; measures ability to identify feelings, describe feeling, and style of thinking	4 weeks

Secondary Outcomes

Measure	Description	Time Frame
Quality of life (SF-36), perceived grade of tinnitus (THI, TF, TBF-12) and the clinical characteristic of tinnitus.	composite outcome	4 weeks
comorbidities	measured with BAI , BDI

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

all patients older than 18 years with tinnitus who want to participate the investigation during the period of data acquisition

Exclusion criteria:

patients younger than 18 years,
insufficient knowledge of the German language.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with tinnitus

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Steffi Weidt, MD	University Hospital Zurich, Division of Psychiatry and Psychotherapy	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Zurich, Division of Psychiatry and Psychotherapy		Zurich	Canton of Zurich	8091	Switzerland

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28476163	Derived	Peter N, Kleinjung T, Jeker R, Meyer M, Klaghofer R, Weidt S. Tinnitus functional index: validation of the German version for Switzerland. Health Qual Life Outcomes. 2017 May 5;15(1):94. doi: 10.1186/s12955-017-0669-x.

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