NCT01837368

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

December 1, 2012

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

December 19, 2012

Completed
4 months until next milestone

First Posted

Study publicly available on registry

April 23, 2013

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

May 10, 2016

Status Verified

May 1, 2016

Enrollment Period

3.4 years

First QC Date

December 19, 2012

Last Update Submit

May 9, 2016

Conditions

Tinnitus

Outcome Measures

Primary Outcomes (2)

  • 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 (3)

  • Quality of life (SF-36), perceived grade of tinnitus (THI, TF, TBF-12) and the clinical characteristic of tinnitus.

    4 weeks

  • comorbidities

    4 weeks

  • Tinnitus functional index (TFI) perceived grade of tinnitus

    4 weeks

Interventions

observational researchOTHER

It is a observational research, no intervention are performed

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with tinnitus

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Zurich, Division of Psychiatry and Psychotherapy

Zurich, Canton of Zurich, 8091, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 28476163DERIVED

Related Links

MeSH Terms

Conditions

Tinnitus

Condition Hierarchy (Ancestors)

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

Study Officials

  • Steffi Weidt, MD

    University Hospital Zurich, Division of Psychiatry and Psychotherapy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2012

First Posted

April 23, 2013

Study Start

December 1, 2012

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

May 10, 2016

Record last verified: 2016-05

Locations

CH(1)