Clinical trial NCT01837368: Research Project About Psychological Strain, Quality of Life and Emotional Awareness in Patients With Tinnitus
Official title: Research Project About Psychological Strain, Quality of Life and Emotional Awareness in Patients With Tinnitus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tinnitus
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2013-04-23
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with tinnitus

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.

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.

Primary outcomes:
measure: Values of PRISM
timeFrame: 4 weeks
measure: TAS
timeFrame: 4 weeks
Secondary outcomes:
measure: Quality of life (SF-36), perceived grade of tinnitus (THI, TF, TBF-12) and the clinical characteristic of tinnitus.
timeFrame: 4 weeks
measure: comorbidities
timeFrame: 4 weeks
measure: Tinnitus functional index (TFI) perceived grade of tinnitus
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Division of Psychiatry and Psychotherapy
state: ZH
Study officials:
affiliation: University Hospital Zurich, Division of Psychiatry and Psychotherapy
name: Steffi Weidt, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.