TinnitusNCT01837368
Research Project About Psychological Strain, Quality of Life and Emotional Awareness in Patients With Tinnitus
An observational study of Tinnitus, run by University of Zurich at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tinnitus
- What is being tested?
- observational research
- How many people
- 250 participants
- Where
- 1 siteSwitzerland
- Study dates
- Dec 2012to May 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with tinnitus
Who may be able to join
- all patients older than 18 years with tinnitus who want to participate the investigation during the period of data acquisition
Who cannot join
- patients younger than 18 years,
- insufficient knowledge of the German language.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich, Division of Psychiatry and Psychotherapy
Zurich, Canton of Zurich, 8091
About this study
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.
Read the 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.
- Conditions
- Tinnitus
- Being tested
- observational research
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observational researchOther
It is a observational research, no intervention are performed
What is being measured
The primary outcome is the main question the study is designed to answer.
Values of PRISM
measures the burden of suffering
Measured: 4 weeks
TAS
Alexithymia- measured with TAS-toronto alexithymia scale; measures ability to identify feelings, describe feeling, and style of thinking
Measured: 4 weeks
Secondary outcomes (3)
Quality of life (SF-36), perceived grade of tinnitus (THI, TF, TBF-12) and the clinical characteristic of tinnitus.
composite outcome
Measured: 4 weeks
comorbidities
measured with BAI , BDI
Measured: 4 weeks
Tinnitus functional index (TFI) perceived grade of tinnitus
Composite outcome
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2013 (estimated)
- Study startDec 2012
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TinnitusStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steffi Weidt, MD, Principal investigator, University Hospital Zurich, Division of Psychiatry and Psychotherapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01837368
- Sponsor's protocol ID
- tinnitus_T0
- Status last verified
- May 2016
- First submitted
- 19 Dec 2012
- Last updated
- 10 May 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28476163
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research Project About Psychological Strain, Quality of Life and Emotional Awareness in Patients With Tinnitus
- ClinicalTrials.gov ID
- NCT01837368
- Acronym / sponsor ID
- tinnitus_T0
- Conditions
- Tinnitus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 23 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with tinnitus
Key inclusion criteria (1 listed)
- all patients older than 18 years with tinnitus who want to participate the investigation during the period of data acquisition
Key exclusion criteria (2 listed)
- patients younger than 18 years,
- insufficient knowledge of the German language.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| observational researchIt is a observational research, no intervention are performed | Other | – |
Primary outcome
Values of PRISM
Time frame: 4 weeks
measures the burden of suffering
TAS
Time frame: 4 weeks
Alexithymia- measured with TAS-toronto alexithymia scale; measures ability to identify feelings, describe feeling, and style of thinking
3 secondary outcomes
Quality of life (SF-36), perceived grade of tinnitus (THI, TF, TBF-12) and the clinical characteristic of tinnitus.
Time frame: 4 weeks
comorbidities
Time frame: 4 weeks
Tinnitus functional index (TFI) perceived grade of tinnitus
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2016.
- Derived from this study: PubMed 28476163Peter 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.
- Publication Tinnitus and PRISMLink provided by the sponsor.
- Publication Tinnitus and quality of lifeLink provided by the sponsor.
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Enrolling by invitationObservational study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steffi Weidt, MD principal investigator
University Hospital Zurich, Division of Psychiatry and Psychotherapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tinnitus, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Values of PRISM (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01837368, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2016.