1. A multi-disciplined approach to tinnitus research
Nottingham Hearing Biomedical Research Unit
Kathryn Fackrell
15/04/2017

2. A multi-disciplined approach to tinnitus research
Measuring tinnitus
Evaluating interventions
Functional connectivity in the tinnitus brain
Efficacy of sound devices
Efficacy of novel compounds
Benefit of self-help programmes
Effectiveness of audiologist-delivered counselling
Efficacy of (combination) hearing aids devices
Validation of measures of tinnitus
Exploring therapeutic target
Validation of a new cognitive model of tinnitus
Effect of tinnitus on working memory and attention
Addressing questions that are important to patients and clinicians

3. Effectiveness of audiologist-delivered counselling
“‘Talking therapies’ will have an increased role to play in NHS care generally”
Cognitive Behaviour Therapy
Offers a practical solution to dealing with current problems
Counselling
Aims to empower patients to reach decisions and take actions for themselves
Tinnitus Priority Setting Partnership: One of the top 10 unanswered questions
Where psychologists are not available, the audiologist’s role should extend to offering psychological treatment through CBT or other appropriate counselling techniques.”
Establishing a therapeutic relationship, clarifying and defining problems, planning actions, and managing expectations are all key features of the approach (Culley 2004).

4. Manualisation and feasibility of audiologist-delivered counselling for tinnitus
Dawn Marie-Walker
David Stockdale
Deb Hall
Mary McMurran
Amanda Casey

5. Manualisation and feasibility of audiologist-delivered counselling for tinnitus
Develop a manual for audiologist-delivered talking therapy and test its feasibility
Several interacting components
Target a wide range of possible outcomes
Have a permitted degree of flexibility or tailoring,
What are the essential components of talking therapy for tinnitus that can be delivered by audiologists?

6. Identifying components
Step one: Scoping review
Course materials articles, practical guidelines, protocols from relevant clinical trials, commentaries and professional magazine articles
Step two: Consultation - Delphi review
Develop a consensus on..
the essential components
associated aims of tinnitus counselling
From the shared perspective of the patient and the clinician.

7. Identifying components
Step two: Consultation - Delphi review
Who do we need?
20 patients
experienced some form of counselling or CBT for tinnitus complaint
From an audiologist, hearing therapist, or clinical psychologist
20 audiologists/hearing therapists
received training in counselling or CBT and consult tinnitus patients
Derek Hoare:

8. Evaluating self-help programmes: update
Study one: Usability of program
Gaining opinion of both the website and program
New users who will
Complete the 6 week program
Complete survey each week
People who have previously used the program
Complete one off survey
The tinnitus e-programme is an online programme in which patients work though educational materials over 6 weeks. These programmes were chosen as they vary in terms of their delivery method and the amount of condition-specific content they offer.
Identifying evidence-base and theory
What do we know about self-help already? Does it work? Why does it work?
2) Pilot study
In the pilot phase, utilise PPI to help design the study and explore what is the most feasible way to evaluate these programmes
3) Process and outcome evaluation
The main evaluation will take a mixed methods approach. It will involve a questionnaire study and patients’ views and experiences of the programme - allow us to identify what works and what doesn’t and how the programmes can be improved in the future.
Sandra Smith:

9. A Randomised Placebo Controlled Double- blind trial of AUT00063 drug
Investigate the efficacy and safety of AUT00063 drug versus placebo
Reduced activity at certain sites in the brain has been linked to hearing problems, such as tinnitus
voltage-gated potassium channels may be a drug target for hearing-related problems.
an experimental new medicine
improve the action of these specific channels
treat the brain component of these hearing problems
early-onset subjective tinnitus
Please follow the link for more information:  
Reduced activity at certain sites in the brain (called "voltage-gated potassium channels") has been linked to hearing problems, like age-related loss of hearing or tinnitus (a 'ringing' or buzzing noise in the ears).

10. An update on my PhD
Validation of the TFI

11. The importance of questionnaires
How?
Diagnostic tool
Why?
Why?
Assess tinnitus severity
Triaging patients
Grade tinnitus severity
Selection criteria
Guiding decisions
To determine treatment candidacy
Identify minimal important change
To facilitate clinical audit
Counsel patient therefore providing feedback
Out-come based commissioning – clinicians have to show evidence of effective management
To ascertain key standards of best practice for tinnitus in order to find the most effective forms of management to prescribe, given particular symptoms
To compare new management strategies – before adoption into clinical practice – provide high level evidence of efficacy
Inform treatment approaches
To compare new management
Counsel patient
Evaluate treatment approaches & interventions
Outcome measure
Hoare & Hall (2011)

12. Validating a new tinnitus questionnaire: Tinnitus Functional Index (TFI)
Does the questionnaire reflect what it is measuring?
Does the questionnaire compare to others tinnitus questionnaires?
Does the questionnaire reliably show changes that occur over time?
Is there a grading system?
Diagnostic tool & measure of change of tinnitus distress

13. UK clinical population
250 new tinnitus patients
Final participants complete this April!

14. TFI score distribution
Clinical population
Research population
Mean score:
Mean score:

15. Clinic overall scores
N: 252

16. Aintree: TFI shows changes over time
60.78
43.83
N: 15

17. Responsiveness: research population
Floor and ceiling effects: limit the detect of worsening and improvements. To be a questionnaire that will be good as an outcome measures the items need to detect small improvements. OS far using the research population, we have found some floor effects.
Floor and ceiling effects: limited detection of individual improvements and worsening

18. Responsiveness: clinics population
Floor and ceiling effects: limit the detect of worsening and improvements. To be a questionnaire that will be good as an outcome measures the items need to detect small improvements. OS far using the research population, we have found some floor effects.
Floor and ceiling effects: limited detection of individual improvements and worsening

19. UK clinical population
250 new tinnitus patients
Factorial structure
Any identified domains/subscales
Is the structure reliable?
Reproducibility
Can it reliably distinguish between people?
Responsiveness
Does it reliably show small changes that occur over time?
Is there a minimal important change score?
Interpretability
What do the scores mean?

20. Thank you for listening
Nottingham Hearing Biomedical Research Unit:
Sandra Smith:
Kathryn Fackrell:
Derek Hoare:

21. Acoustic CR ® Neuromodulation
Specific sound stimulation algorithm developed by the ANM Adaptive Neuromodulation to break up patterns of abnormal synchronous activity in the hearing brain.
Two-centre Double blind RESET II trial
“The report clearly details the methodology and also the changes in the trial protocol – both approved and also the non-compliances. The End of Study Report did not report a significant difference in the primary outcome measure (global Tinnitus Handicap Questionnaire scores) between the treatment group and the placebo group”.
BTA 2014_sourced 04/02/2015
CE marking (Feb ‘10)
FDA approval (Dec ‘11)
Tinnitus Clinic, UK (est. May ‘11)
Phase 1 trial in Germany
Specific sound stimulation algorithm developed by the ANM Adaptive Neuromodulation to break up patterns of abnormal synchronous activity in the hearing brain.
Neurons firing spontaneously – neural synchronicity – the sounds disrupt the neurons firing
The pitch of the tinnitus to identify the pattern of sounds, these are around they pitch 2 above/below-