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

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

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).

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

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?

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.

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: Derek.hoare@nottingham.ac.uk

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: sandra.smith@nottingham.ac.uk

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: http://www.autifony.com/autifony-tinnitus-quiet-study.asp   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).

An update on my PhD Validation of the TFI

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)

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

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

TFI score distribution Clinical population Research population Mean score: 52.6849 Mean score: 39.3175

Clinic overall scores N: 252

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

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

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

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?

Thank you for listening Nottingham Hearing Biomedical Research Unit: www.hearing.nihr.ac.uk Sandra Smith: sandra.smith@nottingham.ac.uk Kathryn Fackrell: msxklf@nottingham.ac.uk Derek Hoare: derek.hoare@nottingham.ac.uk http://www.autifony.com/autifony-tinnitus-quiet-study.asp

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-