Presentation on theme: "A multi-disciplined approach to tinnitus research"— Presentation transcript:
1A multi-disciplined approach to tinnitus research Nottingham Hearing Biomedical Research UnitKathryn Fackrell15/04/2017
2A multi-disciplined approach to tinnitus research Measuring tinnitusEvaluating interventionsFunctional connectivity in the tinnitus brainEfficacy of sound devicesEfficacy of novel compoundsBenefit of self-help programmesEffectiveness of audiologist-delivered counsellingEfficacy of (combination) hearing aids devicesValidation of measures of tinnitusExploring therapeutic targetValidation of a new cognitive model of tinnitusEffect of tinnitus on working memory and attentionAddressing questions that are important to patients and clinicians
3Effectiveness of audiologist-delivered counselling “‘Talking therapies’ will have an increased role to play in NHS care generally”Cognitive Behaviour TherapyOffers a practical solution to dealing with current problemsCounsellingAims to empower patients to reach decisions and take actions for themselvesTinnitus Priority Setting Partnership: One of the top 10 unanswered questionsWhere 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).
4Manualisation and feasibility of audiologist-delivered counselling for tinnitus Dawn Marie-WalkerDavid StockdaleDeb HallMary McMurranAmanda Casey
5Manualisation and feasibility of audiologist-delivered counselling for tinnitus Develop a manual for audiologist-delivered talking therapy and test its feasibilitySeveral interacting componentsTarget a wide range of possible outcomesHave a permitted degree of flexibility or tailoring,What are the essential components of talking therapy for tinnitus that can be delivered by audiologists?
6Identifying components Step one: Scoping reviewCourse materials articles, practical guidelines, protocols from relevant clinical trials, commentaries and professional magazine articlesStep two: Consultation - Delphi reviewDevelop a consensus on..the essential componentsassociated aims of tinnitus counsellingFrom the shared perspective of the patient and the clinician.
7Identifying components Step two: Consultation - Delphi reviewWho do we need?20 patientsexperienced some form of counselling or CBT for tinnitus complaintFrom an audiologist, hearing therapist, or clinical psychologist20 audiologists/hearing therapistsreceived training in counselling or CBT and consult tinnitus patientsDerek Hoare:
8Evaluating self-help programmes: update Study one: Usability of programGaining opinion of both the website and programNew users who willComplete the 6 week programComplete survey each weekPeople who have previously used the programComplete one off surveyThe 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 theoryWhat do we know about self-help already? Does it work? Why does it work?2) Pilot studyIn the pilot phase, utilise PPI to help design the study and explore what is the most feasible way to evaluate these programmes3) Process and outcome evaluationThe 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:
9A Randomised Placebo Controlled Double- blind trial of AUT00063 drug Investigate the efficacy and safety of AUT00063 drug versus placeboReduced activity at certain sites in the brain has been linked to hearing problems, such as tinnitusvoltage-gated potassium channels may be a drug target for hearing-related problems.an experimental new medicineimprove the action of these specific channelstreat the brain component of these hearing problemsearly-onset subjective tinnitusPlease 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).
11The importance of questionnaires How?Diagnostic toolWhy?Why?Assess tinnitus severityTriaging patientsGrade tinnitus severitySelection criteriaGuiding decisionsTo determine treatment candidacyIdentify minimal important changeTo facilitate clinical auditCounsel patient therefore providing feedbackOut-come based commissioning – clinicians have to show evidence of effective managementTo ascertain key standards of best practice for tinnitus in order to find the most effective forms of management to prescribe, given particular symptomsTo compare new management strategies – before adoption into clinical practice – provide high level evidence of efficacyInform treatment approachesTo compare new managementCounsel patientEvaluate treatment approaches & interventionsOutcome measureHoare & Hall (2011)
12Validating 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
13UK clinical population 250 new tinnitus patientsFinal participants complete this April!
14TFI score distribution Clinical populationResearch populationMean score:Mean score:
16Aintree: TFI shows changes over time 60.7843.83N: 15
17Responsiveness: 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
18Responsiveness: 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
19UK clinical population 250 new tinnitus patientsFactorial structureAny identified domains/subscalesIs the structure reliable?ReproducibilityCan it reliably distinguish between people?ResponsivenessDoes it reliably show small changes that occur over time?Is there a minimal important change score?InterpretabilityWhat do the scores mean?
20Thank you for listening Nottingham Hearing Biomedical Research Unit:Sandra Smith:Kathryn Fackrell:Derek Hoare:
21Acoustic 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 04/02/2015CE marking (Feb ‘10)FDA approval (Dec ‘11)Tinnitus Clinic, UK (est. May ‘11)Phase 1 trial in GermanySpecific 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 firingThe pitch of the tinnitus to identify the pattern of sounds, these are around they pitch 2 above/below-