Genetically-informed Behavioral and Cognitive Interventions for the Management of Tinnitus

Tinnitus Clinical Trial

Official title:

Genetically-informed Behavioral and Cognitive Interventions for the Management of Tinnitus

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04675112
• Other study ID #: No 208/2019
• Status: Enrolling by invitation
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: December 2022

Study information

• Verified date: December 2020
• Source: National and Kapodistrian University of Athens
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 20
• Est. completion date: December 2022
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• adult patients with bothersome bilateral non-pulsative tinnitus and hearing loss

Exclusion Criteria:

• no major comorbidities
• no psychiatric history

Related Conditions & MeSH terms

• Tinnitus

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Greece	ENT clinic	Athens

Sponsors (1)

Lead Sponsor	Collaborator
Gkouskou Kalliopi

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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]	4 months