search
Back to results

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

Primary Purpose

Tinnitus

Status
Unknown status
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Cognitive Behavioral Treatment (CBT) and Tinnitus Retraining Therapy (TRT)
Sponsored by
Gkouskou Kalliopi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tinnitus

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • no major comorbidities
  • no psychiatric history

Sites / Locations

  • ENT clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

group A genetically informed intervention

group B control

Arm Description

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

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

Outcomes

Primary Outcome Measures

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]

Secondary Outcome Measures

Full Information

First Posted
December 15, 2020
Last Updated
December 19, 2020
Sponsor
Gkouskou Kalliopi
search

1. Study Identification

Unique Protocol Identification Number
NCT04675112
Brief Title
Genetically-informed Behavioral and Cognitive Interventions for the Management of Tinnitus
Official Title
Genetically-informed Behavioral and Cognitive Interventions for the Management of Tinnitus
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Gkouskou Kalliopi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinnitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
group A genetically informed intervention
Arm Type
Experimental
Arm Description
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
Arm Title
group B control
Arm Type
Other
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Treatment (CBT) and Tinnitus Retraining Therapy (TRT)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Tinnitus Handicap Inventory (THI)
Description
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]
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: adult patients with bothersome bilateral non-pulsative tinnitus and hearing loss Exclusion Criteria: no major comorbidities no psychiatric history
Facility Information:
Facility Name
ENT clinic
City
Athens
Country
Greece

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs