TinnitusNCT04675112
Genetically-informed Behavioral and Cognitive Interventions for the Management of Tinnitus
A study testing Cognitive Behavioral Treatment (CBT) and Tinnitus Retraining Therapy (TRT) in people with Tinnitus, run by Gkouskou Kalliopi at 1 site in Greece.
Trial summary
Psychological and behavioral interventions, such as Cognitive Behavioral Treatment (CBT) and Tinnitus Retraining Therapy (TRT), are commonly applied either alone or in combination for the management of tinnitus but selection of the intervention model remains arbitrary. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Tinnitus
- What is being tested?
- Cognitive Behavioral Treatment (CBT) and Tinnitus Retraining Therapy (TRT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGreece
- Study dates
- 1 Jan 2019to Dec 2022
- Phase
- Interventional
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- adult patients with bothersome bilateral non-pulsative tinnitus and hearing loss
Who cannot join
- no major comorbidities
- no psychiatric history
Trial locations and contacts
1 site in 1 country.
About this study
Psychological and behavioral interventions, such as Cognitive Behavioral Treatment (CBT) and Tinnitus Retraining Therapy (TRT), are commonly applied either alone or in combination for the management of tinnitus but selection of the intervention model remains arbitrary. Our purpose is to evaluate the hypothesis that genetic markers may guide the choice of tinnitus treatment towards improved therapeutic outcomes. Patients with subjective idiopathic tinnitus are assigned to either a genetically-informed CBT or TRT intervention protocol based on the status of four single nucleotide polymorphisms (SNPs) of the dopamine and serotonin pathways, namely COMT rs4680, HTR2A rs7997012, HTR2A rs6311, and TPH2 rs4570625, that have been associated with behavioral or cognitive responses (Group A), or to a conventional approach (Group B) in which the choice of treatment was not directed by genotypic data. Tinnitus Handicap Index (THI) scores of perceived tinnitus severity are recorded at the initial and at the fourth session of treatment using appropriate questionnaires.
- Conditions
- Tinnitus
- Being tested
- Cognitive Behavioral Treatment (CBT) and Tinnitus Retraining Therapy (TRT)
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Treatment (CBT) and Tinnitus Retraining Therapy (TRT)Behavioural
CBT is a psychologically informed treatment. Depending on individual patient needs, relevant areas of tinnitus education and management/self-management strategies, such as managing the emotional consequences of tinnitus, rapid relaxation, managing fear and avoidance behaviors and changing unhelpful thoughts and beliefs, are applied in accordance to a published manual [10].
TRT is based on the neurophysiological model focusing more on education and sound therapy than on analytical cognitive and behavioral interventions. A TRT program is usually included in a management scheme with hearing aids.
| Study group | Role | What they receive |
|---|---|---|
| group A genetically informed intervention | Experimental | Group A patients are offered a genetically based approach to tinnitus management that includes a genetic test and at least three office based treatment sessions. A rationally-designed personalized management plan based on the genetic results is based on four single nucleotide polymorphisms (SNPs) of the dopamine and serotonin pathways, namely COMT rs4680, HTR2A rs7997012, HTR2A rs6311, and TPH2 rs4570625, that have been associated with behavioral or cognitive responses Receives: Behavioral: Cognitive Behavioral Treatment (CBT) and Tinnitus Retraining Therapy (TRT) |
| group B control | Other | In Group B, treatments are offered randomly taking care to offer CBT to equal number of patients as in Group A. In both groups, during the first visit, patients are offered a simple, few-minute tinnitus update and advice, relevant to their educational level and are being suggested that an average of 4 sessions are required over a period of approx. 4 months for making tinnitus noise less or not bothersome Receives: Behavioral: Cognitive Behavioral Treatment (CBT) and Tinnitus Retraining Therapy (TRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tinnitus Handicap Inventory (THI)
Upon a detailed history and an integrated ENT and audiological examination, the patients are asked to answer the THI twice (pre and post treatment), a questionnaire that quantifies the impact of tinnitus on everyday function. It is psychometrically robust and demonstrates adequate reliability and validity [9]
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2020
- Study start1 Jan 2019
- Primary completion31 Dec 2020 (estimated)
- Study completionDec 2022 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gkouskou Kalliopi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gkouskou Kalliopi, National and Kapodistrian University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04675112
- Sponsor's protocol ID
- No 208/2019
- Status last verified
- Dec 2020
- First submitted
- 15 Dec 2020
- Last updated
- 22 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetically-informed Behavioral and Cognitive Interventions for the Management of Tinnitus
- ClinicalTrials.gov ID
- NCT04675112
- Acronym / sponsor ID
- No 208/2019
- Conditions
- Tinnitus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Gkouskou KalliopiUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 19 Dec 2020 (actual)
- 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.
Psychological and behavioral interventions, such as Cognitive Behavioral Treatment (CBT) and Tinnitus Retraining Therapy (TRT), are commonly applied either alone or in combination for the management of tinnitus but selection of the intervention model remains arbitrary. Our purpose is to evaluate the hypothesis that genetic markers may guide the choice of tinnitus treatment towards improved therapeutic outcomes. Patients with subjective idiopathic tinnitus are assigned to either a genetically-informed CBT or TRT intervention protocol based on the status of four single nucleotide polymorphisms (SNPs) of the dopamine and serotonin pathways, namely COMT rs4680, HTR2A rs7997012, HTR2A rs6311, and TPH2 rs4570625, that have been associated with behavioral or cognitive responses (Group A), or to a conventional approach (Group B) in which the choice of treatment was not directed by genotypic data. Tinnitus Handicap Index (THI) scores of perceived tinnitus severity are recorded at the initial and at the fourth session of treatment using appropriate questionnaires.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A genetically informed intervention | Experimental | Behavioral: Cognitive Behavioral Treatment (CBT) and Tinnitus Retraining Therapy (TRT)Group A patients are offered a genetically based approach to tinnitus management that includes a genetic test and at least three office based treatment sessions. A rationally-designed personalized management plan based on the genetic results is based on four single nucleotide polymorphisms (SNPs) of the dopamine and serotonin pathways, namely COMT rs4680, HTR2A rs7997012, HTR2A rs6311, and TPH2 rs4570625, that have been associated with behavioral or cognitive responses |
| group B control | Other | Behavioral: Cognitive Behavioral Treatment (CBT) and Tinnitus Retraining Therapy (TRT)In Group B, treatments are offered randomly taking care to offer CBT to equal number of patients as in Group A. In both groups, during the first visit, patients are offered a simple, few-minute tinnitus update and advice, relevant to their educational level and are being suggested that an average of 4 sessions are required over a period of approx. 4 months for making tinnitus noise less or not bothersome |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adult patients with bothersome bilateral non-pulsative tinnitus and hearing loss
Key exclusion criteria (2 listed)
- no major comorbidities
- no psychiatric history
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 Treatment (CBT) and Tinnitus Retraining Therapy (TRT)CBT is a psychologically informed treatment. Depending on individual patient needs, relevant areas of tinnitus education and management/self-management strategies, such as managing the emotional consequences of tinnitus, rapid relaxation, managing fear and avoidance behaviors and changing unhelpful thoughts and beliefs, are applied in accordance to a published manual [10]. TRT is based on the neurophysiological model focusing more on education and sound therapy than on analytical cognitive and behavioral interventions. A TRT program is usually included in a management scheme with hearing aids. | Behavioural | group A genetically informed intervention, group B control |
Primary outcome
Tinnitus Handicap Inventory (THI)
Time frame: 4 months
Upon a detailed history and an integrated ENT and audiological examination, the patients are asked to answer the THI twice (pre and post treatment), a questionnaire that quantifies the impact of tinnitus on everyday function. It is psychometrically robust and demonstrates adequate reliability and validity [9]
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2020.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Treatment (CBT) and Tinnitus Retraining Therapy (TRT) in people with Tinnitus, run by Gkouskou Kalliopi at 1 site in Greece.
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: status not confirmed, as of the sponsor's last update on 22 Dec 2020. 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 Greece. 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?
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 Handicap Inventory (THI) (time frame: 4 months). 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 22 Dec 2020.