TinnitusNCT02632058
Efficacy of Treatment for Tinnitus
An observational study of Tinnitus, run by Psychiatrische Dienste Graubuenden.
Trial summary
Tinnitus is the acoustic perception of sound without any physical source. It is estimated that 15-21% of adults develop a Tinnitus, which can cause serious distress and debilitation in all aspects of daily life of the affected. There is currently no evidence for a successful treatment of 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?
- Cognitive Behavioral Therapy
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- Aug 2015to Jul 2017
- 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: The study population consists of patients suffering from chronic tinnitus referred to our clinic by their treating physician. There is a remarkable level of suffering from chronic tinnitus in these individuals. The participants received an established routine treatment as part of multimodal treatment at an inpatient psychiatric facility. Clinical experience shows that the applied treatment poses a low risk and demonstrates a great amount of benefit. At admission to our clinic all participants were of age and able to give their consent to treatment.
Who may be able to join
- minimum age of 18,
- existing Tinnitus auris or capitis
Who cannot join
- Psychosis,
- serious physical illness,
- Organic psychiatric disability (ICD-10 F0x.x),
- diseases classified under ICD-10 F2x.x,
- Lack of capacity,
- current substance abuse (F10.x - F19.x according to ICD-10, F17.x not included),
- insufficient knowledge of German.
About this study
Official title: Efficacy of Treatment for Tinnitus Based on Cognitive Behavioural Therapy in an Inpatient Setting: a 10-year Retrospective Outcome Analysis
Tinnitus is the acoustic perception of sound without any physical source. It is estimated that 15-21% of adults develop a Tinnitus, which can cause serious distress and debilitation in all aspects of daily life of the affected.
There is currently no evidence for a successful treatment of tinnitus. While one treatment approach involves sound-based therapies, e.g. tinnitus retraining therapy. The treatment aspect in our setting involved cognitive behavioural therapy.
Read the detailed description
Tinnitus is the perception of sound in the ears or head unrelated to an external source [Nondahl 2011]. It is a common condition with a prevalence of 25.3% (approximately 50 million) among adults in the United States and increasing with age, peaking at age 60 - 69 years [Shargorodsky 2012] and above the age of 55 years respectively [Nondahl 2012]. Of individuals with tinnitus, 7.9% (approximately 16 million) experience frequent tinnitus which involves perception at least once daily [Shargorodsky 2012]. Prevalence of tinnitus in adults in Europe is described at a similar level with 21.2% [Hendrickx 2007]. In Switzerland prevalence for tinnitus in individuals over the age of 15 years is 20%; of these 13% report having a current tinnitus and 7% report of having had tinnitus in the past five years. [Bieri 2012]. It has been shown that the 10-year cumulative incidence for tinnitus is 12.7% [Nondahl 2010]. Gender seems to play a role in the predisposition for tinnitus; prevalence for men is 26.1% and for women 24.6% [Shargorodsky 2012], while the incidence for men is 14.8% and for women 11.2% [Nondahl 2010]. There is indication that there is also a gender-related level of affliction related to tinnitus, so that women feel more distress [Seydel 2013] and emotional disturbance than men [Pajor 2012].
It has also been shown for tinnitus to have a familial occurrence; subjects related to a sibling with tinnitus have a 1.7 times higher probability to have tinnitus than subjects from a family without tinnitus. [Hendrickx 2007]. Tinnitus perceived as severe has a prevalence of 1.3% [Nondahl 2012].
Risk factors for developing tinnitus are numerous and include conditions involving auditory function (i.e. hearing impairment, exposure to noise and history of ear surgery, head injury or otosclerosis), cardiovascular-related (i.e. cardiovascular disease, peripheral vascular disease, obesity, current smoking, higher number of packyears smoked and history of heavy alcohol consumption) [Nondahl 2012].
Tinnitus is also known to be associated with various complaints such as sleep disturbances, which are reported to be greater in elderly people [Hebert 2007], although there seems to be no difference between people suffering from insomnia with or without tinnitus, which was measured in a population of 38-62 year olds [Crönlein 2007]. Furthermore, tinnitus severity significantly correlates with depression and anxiety symptoms [Udupi 2013]. In addition, there is a higher incidence of somatoform disorders in individuals with tinnitus [Zirke 2013]. Although the severity of tinnitus is associated with anxiety and depression, a causality cannot be concluded [Zöger 2006].
Concerning treatment of tinnitus, tinnitus masking and tinnitus retraining therapy are two successfully applied methods. While both methods use counseling and acoustic stimulation for intervention, the main objective in tinnitus masking is to use wide-band noise applied through ear-level devices, in order to provide immediate relief from tinnitus [Henry 2006]. Although both methods show remarkable improvement in ameliorating tinnitus, in comparison the effects of tinnitus retraining therapy improve progressively over time [Henry 2006]. The results of tinnitus retraining therapy also sustain over time [Forti 2009] and improve quality of life of those affected [Seydel 2014].
In recent years there have been numerous publications implementing a therapeutic model based on cognitive behavioral therapy with a sound-focused tinnitus retraining therapy, proving its effectiveness and long-term effects [Herraiz 2005, Robinson 2008, Zenner 2012, Cima 2012], with long-term effects persisting 15 years after completion of the therapy-program [Goebbel 2006]. Also, tinnitus retraining therapy carried out as a short-term therapy in an outpatient setting has also showed to be maintained over time [Mazurek 2009]. Apart from its therapeutic effectiveness tinnitus therapy based on cognitive therapy shows an increased cost-effectiveness compared to usual therapy [Maes 2014].
In the tinnitus-clinic in Chur we have been treating patients with a modified tinnitus-retraining program based on cognitive therapy for a decade. Patients are either admitted by their general practitioner, Otolaryngologist or self-admitted. We offer capacity to treat nation-wide patients in an inpatient setting, for a modified tinnitus retraining therapy lasting four to six-weeks, depending on severity of comorbid factors. Up to date, there is no other clinic in Switzerland treating individuals in an inpatient setting to the likes of ours. Admitted patients usually have a long way of suffering with an unsuccessful search for enduring relief. With this study we intend to show an improvement in treatment of tinnitus based upon our model of modified tinnitus retraining therapy. If our therapeutic model is successful, many individuals could benefit from a substantial improvement in quality of life.
- Conditions
- Tinnitus
- Being tested
- Cognitive Behavioral Therapy
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
What is being measured
The primary outcome is the main question the study is designed to answer.
Tinnitus-severity assessed with the Tinnitus-questionnaire (Goebel and Hiller 1998).
Measured: 6-8 weeks
Secondary outcomes (3)
Brief Symptom Inventory (BSI, Derogatis 1975)
Measured: 6-8 weeks
Beck Depression Inventory (BDI, Beck 1961)
Measured: 6-8 weeks
Noise Sensitivity Questionnaire [Nelting 2004]
Measured: 6-8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2015 (estimated)
- Study startAug 2015
- Primary completionDec 2016 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TinnitusStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Psychiatrische Dienste Graubuenden
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02632058
- Sponsor's protocol ID
- KEK-ZH-not defined
- Status last verified
- Dec 2015
- First submitted
- 14 Dec 2015
- Last updated
- 16 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Treatment for Tinnitus Based on Cognitive Behavioural Therapy in an Inpatient Setting: a 10-year Retrospective Outcome Analysis
- ClinicalTrials.gov ID
- NCT02632058
- Acronym / sponsor ID
- KEK-ZH-not defined
- Conditions
- Tinnitus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Psychiatrische Dienste GraubuendenUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 16 Dec 2015 (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.
Tinnitus is the acoustic perception of sound without any physical source. It is estimated that 15-21% of adults develop a Tinnitus, which can cause serious distress and debilitation in all aspects of daily life of the affected.
There is currently no evidence for a successful treatment of tinnitus. While one treatment approach involves sound-based therapies, e.g. tinnitus retraining therapy. The treatment aspect in our setting involved cognitive behavioural therapy.
Detailed description
Tinnitus is the perception of sound in the ears or head unrelated to an external source [Nondahl 2011]. It is a common condition with a prevalence of 25.3% (approximately 50 million) among adults in the United States and increasing with age, peaking at age 60 - 69 years [Shargorodsky 2012] and above the age of 55 years respectively [Nondahl 2012]. Of individuals with tinnitus, 7.9% (approximately 16 million) experience frequent tinnitus which involves perception at least once daily [Shargorodsky 2012]. Prevalence of tinnitus in adults in Europe is described at a similar level with 21.2% [Hendrickx 2007]. In Switzerland prevalence for tinnitus in individuals over the age of 15 years is 20%; of these 13% report having a current tinnitus and 7% report of having had tinnitus in the past five years. [Bieri 2012]. It has been shown that the 10-year cumulative incidence for tinnitus is 12.7% [Nondahl 2010]. Gender seems to play a role in the predisposition for tinnitus; prevalence for men is 26.1% and for women 24.6% [Shargorodsky 2012], while the incidence for men is 14.8% and for women 11.2% [Nondahl 2010]. There is indication that there is also a gender-related level of affliction related to tinnitus, so that women feel more distress [Seydel 2013] and emotional disturbance than men [Pajor 2012].
It has also been shown for tinnitus to have a familial occurrence; subjects related to a sibling with tinnitus have a 1.7 times higher probability to have tinnitus than subjects from a family without tinnitus. [Hendrickx 2007]. Tinnitus perceived as severe has a prevalence of 1.3% [Nondahl 2012].
Risk factors for developing tinnitus are numerous and include conditions involving auditory function (i.e. hearing impairment, exposure to noise and history of ear surgery, head injury or otosclerosis), cardiovascular-related (i.e. cardiovascular disease, peripheral vascular disease, obesity, current smoking, higher number of packyears smoked and history of heavy alcohol consumption) [Nondahl 2012].
Tinnitus is also known to be associated with various complaints such as sleep disturbances, which are reported to be greater in elderly people [Hebert 2007], although there seems to be no difference between people suffering from insomnia with or without tinnitus, which was measured in a population of 38-62 year olds [Crönlein 2007]. Furthermore, tinnitus severity significantly correlates with depression and anxiety symptoms [Udupi 2013]. In addition, there is a higher incidence of somatoform disorders in individuals with tinnitus [Zirke 2013]. Although the severity of tinnitus is associated with anxiety and depression, a causality cannot be concluded [Zöger 2006].
Concerning treatment of tinnitus, tinnitus masking and tinnitus retraining therapy are two successfully applied methods. While both methods use counseling and acoustic stimulation for intervention, the main objective in tinnitus masking is to use wide-band noise applied through ear-level devices, in order to provide immediate relief from tinnitus [Henry 2006]. Although both methods show remarkable improvement in ameliorating tinnitus, in comparison the effects of tinnitus retraining therapy improve progressively over time [Henry 2006]. The results of tinnitus retraining therapy also sustain over time [Forti 2009] and improve quality of life of those affected [Seydel 2014].
In recent years there have been numerous publications implementing a therapeutic model based on cognitive behavioral therapy with a sound-focused tinnitus retraining therapy, proving its effectiveness and long-term effects [Herraiz 2005, Robinson 2008, Zenner 2012, Cima 2012], with long-term effects persisting 15 years after completion of the therapy-program [Goebbel 2006]. Also, tinnitus retraining therapy carried out as a short-term therapy in an outpatient setting has also showed to be maintained over time [Mazurek 2009]. Apart from its therapeutic effectiveness tinnitus therapy based on cognitive therapy shows an increased cost-effectiveness compared to usual therapy [Maes 2014].
In the tinnitus-clinic in Chur we have been treating patients with a modified tinnitus-retraining program based on cognitive therapy for a decade. Patients are either admitted by their general practitioner, Otolaryngologist or self-admitted. We offer capacity to treat nation-wide patients in an inpatient setting, for a modified tinnitus retraining therapy lasting four to six-weeks, depending on severity of comorbid factors. Up to date, there is no other clinic in Switzerland treating individuals in an inpatient setting to the likes of ours. Admitted patients usually have a long way of suffering with an unsuccessful search for enduring relief. With this study we intend to show an improvement in treatment of tinnitus based upon our model of modified tinnitus retraining therapy. If our therapeutic model is successful, many individuals could benefit from a substantial improvement in quality of life.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of patients suffering from chronic tinnitus referred to our clinic by their treating physician. There is a remarkable level of suffering from chronic tinnitus in these individuals. The participants received an established routine treatment as part of multimodal treatment at an inpatient psychiatric facility. Clinical experience shows that the applied treatment poses a low risk and demonstrates a great amount of benefit. At admission to our clinic all participants were of age and able to give their consent to treatment.
Key inclusion criteria (2 listed)
- minimum age of 18,
- existing Tinnitus auris or capitis
Key exclusion criteria (7 listed)
- Psychosis,
- serious physical illness,
- Organic psychiatric disability (ICD-10 F0x.x),
- diseases classified under ICD-10 F2x.x,
- Lack of capacity,
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 |
|---|---|---|
| Cognitive Behavioral Therapy | Other | – |
Primary outcome
Tinnitus-severity assessed with the Tinnitus-questionnaire (Goebel and Hiller 1998).
Time frame: 6-8 weeks
3 secondary outcomes
Brief Symptom Inventory (BSI, Derogatis 1975)
Time frame: 6-8 weeks
Beck Depression Inventory (BDI, Beck 1961)
Time frame: 6-8 weeks
Noise Sensitivity Questionnaire [Nelting 2004]
Time frame: 6-8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2015.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Tinnitus, run by Psychiatrische Dienste Graubuenden.
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 2 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 16 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Tinnitus-severity assessed with the Tinnitus-questionnaire (Goebel and Hiller 1998). (time frame: 6-8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Dec 2015.