Serum Prestin Level May Increase Following Music Exposure That Induces Temporary Threshold Shifts: A Pilot Study.

OBJECTIVES: To determine if blood prestin level changes after exposure to music at high sound pressure levels, and if this change is associated with temporary threshold shift (TTS) and/or changes in distortion product (DP) amplitude. DESIGN: Participants were exposed to pop-rock music at 100 dBA for 15 min monaurally through headphones. Pure-tone audiometry, DP amplitude, and blood prestin level were measured before and after exposure. RESULTS: Fourteen adults (9 women; age range: 20 to 54 years, median age = 31 [Interquartile ratio = 6.75]) with normal hearing were included in the study. Mean prestin level increased shortly after exposure to music, then returned to baseline within 1 week, although this trend was not observed in all participants. All participants presented TTS or a decrease in DP amplitude in at least one frequency after music exposure. There was a statistically significant average threshold elevation at 4 min postexposure. Statistically significant DP amplitude shifts were observed at 4 and 6 kHz, 2 min following exposure. Mean baseline serum prestin level (mean: 140.00 pg/mL, 95% confidence interval (CI): 125.92 to 154.07) progressively increased following music exposure, reaching a maximum at 2 hr (mean: 158.29 pg/mL, 95% CI: 130.42 to 186.66) and returned to preexposure level at 1 week (mean: 139.18 pg/mL, 95% CI: 114.69 to 163.68). However, after correction for multiple comparisons, mean prestin level showed no statistically significant increase from baseline at any timepoint. No correlation between maximum blood prestin level change and average TTS or distortion product otoacoustic emission amplitude shift was found. However, in an exploratory analysis, TTS at 6 kHz (the frequency at which maximum TTS occurred) decreased significantly as baseline blood prestin level increased. CONCLUSIONS: The results suggest that blood prestin level may change after exposure to music at high sound pressure levels, although statistical significance was not reached in this relatively small sample after correction. Baseline serum prestin level may also predict the degree of TTS. These findings thus suggest that the role of baseline serum prestin level as a proxy marker of cochlear susceptibility to intense music exposure should be further explored.

A phase I/IIa safety and efficacy trial of intratympanic gamma-secretase inhibitor as a regenerative drug treatment for sensorineural hearing loss.

Inhibition of Notch signalling with a gamma-secretase inhibitor (GSI) induces mammalian hair cell regeneration and partial hearing restoration. In this proof-of-concept Phase I/IIa multiple-ascending dose open-label trial (ISRCTN59733689), adults with mild-moderate sensorineural hearing loss received 3 intratympanic injections of GSI LY3056480, in 1 ear over 2 weeks. Phase I primary outcome was safety and tolerability. Phase lla primary outcome was change from baseline to 12 weeks in average pure-tone air conduction threshold across 2,4,8 kHz. Secondary outcomes included this outcome at 6 weeks and change from baseline to 6 and 12 weeks in pure-tone thresholds at individual frequencies, speech reception thresholds (SRTs), Distortion Product Otoacoustic Emissions (DPOAE) amplitudes, Signal to Noise Ratios (SNRs) and distribution of categories normal, present-abnormal, absent and Hearing Handicap Inventory for Adults/Elderly (HHIA/E). In Phase I (N = 15, 1 site) there were no severe nor serious adverse events. In Phase IIa (N = 44, 3 sites) the average pure-tone threshold across 2,4,8 kHz did not change from baseline to 6 and 12 weeks (estimated change -0.87 dB; 95% CI -2.37 to 0.63; P = 0.252 and -0.46 dB; 95% CI -1.94 to 1.03; P = 0.545, respectively), nor did the means of secondary measures. DPOAE amplitudes, SNRs and distribution of categories did not change from baseline to 6 and 12 weeks, nor did SRTs and HHIA/E scores. Intratympanic delivery of LY3056480 is safe and well-tolerated; the trial's primary endpoint was not met.

Development and Validation of an Efficient and Safe Loud Music Exposure Paradigm.

PURPOSE: The purpose of this study was to develop a time-efficient music exposure and testing paradigm that safely creates temporary cochlear dysfunction that could be used in future temporary threshold shift (TTS) studies. METHOD: A 30-min audio compilation of pop rock music tracks was created. Adult volunteers with normal hearing were then exposed to this music material monaurally through headphones for 30 min at 97 dBA or 15 min at 100 dBA. Levels were measured from the ear of a manikin and are considered to provide an equivalent daily noise dose based on a 3-dB exchange. We assessed the changes in their hearing, by means of distortion product otoacoustic emission (DPOAE) testing, and standard and extended high-frequency pure-tone audiometry before and after exposure. There were 17 volunteers in total. In the first trial, eight volunteers (four females; Mdnage = 31 years [interquartile range, IQR = 4.25]) were included. Although TTS was observed in all eight participants for at least one frequency, a large variation in affected frequencies was observed. To address this issue, the audio material was further remastered to adjust levels across the different frequency bands. Fourteen adults (nine newly recruited and five from the first trial; seven females; Mdnage = 31 years [IQR = 5]) were exposed to the new material. RESULTS: All but two of 17 participants presented clinically significant TTS or decrease in DPOAE amplitude in at least one frequency. Statistically significant average TTS of 7.43 dB was observed at 6 kHz. There were statistically significant average DPOAE amplitude shifts of -2.55 dB at 4 kHz, -4.97 dB at 6 kHz, and -3.14 dB at 8 kHz. No participant presented permanent threshold shift. CONCLUSIONS: A monaural music paradigm was developed and shown to induce statistically significant TTS and DPOAE amplitude shifts, without evidence of permanent loss. This realistic and time-efficient paradigm may be considered a viable option for experimental studies of temporary music-induced hearing loss. SUPPLEMENTAL MATERIAL: https://doi.org/10.23641/asha.25016471.

Head mounted display effect on vestibular rehabilitation exercises performance.

Objectives: Vestibular rehabilitation clinical guidelines document the additional benefit offered by the Mixed Reality environments in the reduction of symptoms and the improvement of balance in peripheral vestibular hypofunction. The HOLOBalance platform offers vestibular rehabilitation exercises, in an Augmented Reality (AR) environment, projecting them using a low- cost Head Mounted Display. The effect of the AR equipment on the performance in three of the commonest vestibular rehabilitation exercises is investigated in this pilot study. Methods: Twenty-five healthy adults (12/25 women) participated, executing the predetermined exercises with or without the use of the AR equipment. Results: Statistically significant difference was obtained only in the frequency of head movements in the yaw plane during the execution of a vestibular adaptation exercise by healthy adults (0.97 Hz; 95% CI=(0.56, 1.39), p<0.001). In terms of difficulty in exercise execution, the use of the equipment led to statistically significant differences at the vestibular-oculomotor adaptation exercise in the pitch plane (OR=3.64, 95% CI (-0.22, 7.50), p=0.049), and in the standing exercise (OR=28.28. 95% CI (23.6, 32.96), p=0.0001). Conclusion: Τhe use of AR equipment in vestibular rehabilitation protocols should be adapted to the clinicians' needs.

Vocal Health Knowledge Status and Attitudes of Professional and Amateur Performing Artists in Greece.

OBJECTIVE: This study aimed to investigate the vocal health literacy level and attitudes of professional and amateur performing artists in Greece and identify possible gaps and limitations that should be addressed in the future. METHODS: This mixed-methods study took place in two successive stages. The first stage involved 4 focus groups with professional and amateur actors and singers. The focused discussions of this stage, which were moderated by one otolaryngologist and one speech and language therapist, provided necessary information for the design of the structured questionnaire used during the second stage of the study (online survey). The online questionnaire included questions about responders' knowledge and attitudes of vocal health. Although not compulsory, the Greek version of the Singing Voice Handicap Index (SVHI) was also part of the online survey. RESULTS: The online questionnaire was validly answered by 305 respondents during a 10-month period (May 2020 to March 2021). Considerable knowledge gaps were observed regarding anatomy, physiology, and vocal disorders management. The vast majority of participants (94.1%) had at some point experienced problems with their voice. Gastroesophageal reflux (21.6%), vocal nodules (12.5%), and vocal polyps (3.9%) were the most frequently mentioned diagnoses in our sample. A small proportion of participants (9.5%) stated that they have never visited an ENT, while 84.3% have never seen a speech and language therapist. The total scores on the SVHI in our sample were compatible to the ones in previous studies targeting healthy professional and amateur artists (range 0-116, mean 32, SD 24.7). CONCLUSIONS: This study provides insights into Greek performing artists' knowledge and attitudes regarding vocal health and may pave the way towards improving vocal health awareness among performing artists.

Rehearsal Sound Exposure and Choir Singers' Hearing: A Pilot Field Study.

Exposure to high- and moderate-intensity sound is inevitable for professional singers during their working day, the majority of which is spent in rehearsal, preparing for a performance. The impact of self-produced sound exposure on singers' hearing within the rehearsal setting has not been examined. OBJECTIVES: This original pilot field study investigates the feasibility of data collection and hypothesis testing of singers' hearing within the rehearsal environment. METHODS: 18 professional choir singers are examined for hearing threshold changes following routine rehearsal sound exposure. Pure Tone Audiometry is measured before, immediately after, and approximately 24 hours after rehearsal. RESULTS: This study does not identify definitive Temporary Threshold Shift in this population under these conditions. That said, mean temporary threshold shift was found 3.61 dB higher than the recovery threshold shift in the right ear at 3000 Hz (P = 0.06), and this may be important to look at for future studies. CONCLUSIONS: Methodological challenges of this field study include dynamic experimental conditions intrinsic to the rehearsal process, environmental and musical influence on Pure Tone Audiometry results and estimation of sound intensity exposure.

Recommendations for physical activity in the elderly population: A scoping review of guidelines.

Physical inactivity and sedentary time are associated with all-cause mortality, chronic non-communicable diseases and falls in the elderly. Objective of this review is to assess and summarize recommendations from clinical guidelines for physical activity (PA) of older adults in general and related to falls. A scoping review of the existing clinical guidelines was conducted. The included studies should have been developed under the auspices of a health organization and their methodology should be described in detail. Nine clinical guidelines providing specific recommendations for the elderly were identified. There was a strong agreement across the guidelines regarding goals, activities parameters, adverse effects of PA, in addition to reference for preventing falls. Keeping even the minimum of physical activity, introducing balance exercises and strengthening exercises for preventing falls, avoiding unexpected accelerations in the intensity of the activities, applying the necessary precautions and consulting a health professional are the main pillars of recommendations. Despite any deficiencies in definitions, monitoring and optimal dosage consistency of recommendations, is an ideal incentive for countries and organizations to adopt and enhance physical activity as an antidote to the degeneration of human's health and quality of life.

Exploring the Acceptability and Feasibility of Providing a Balance Tele-Rehabilitation Programme to Older Adults at Risk for Falls: An Initial Assessment.

Falls are a major health concern. The HOLOBALANCE tele-rehabilitation system was developed to deliver an evidence based, multi-sensory balance rehabilitation programme, to the elderly at risk of falls. The system delivers a series of balance physiotherapy exercises and cognitive and auditory training tasks prescribed by an expert balance physiotherapist following an initial balance assessment. The HOLOBALANCE system uses augmented reality (AR) to deliver exercises and games, and records task performance via a combination of body worn sensors and a depth camera. The HOLOBALANCE tele-rehabilitation system provides feedback to the supervising clinical team regarding task performance, participant usage and user feedback. Herewith we present the findings from the first 25 study participants regarding the feasibility and acceptability of the proposed system. The results of the clinical study indicate that the system is acceptable by the end users and also feasible for using in hospital and home environments.

Systematic review of sound stimulation to elicit tinnitus residual inhibition.

BACKGROUND: Residual Inhibition is considered as tinnitus alteration immediately after exposure to sound. Its clinical significance and correlation with the pathophysiology and treatment prognosis of tinnitus remain enigmatic. The objective of this review is to critically appraise scientific evidence regarding the residual inhibition prevalence and how it is correlated with different sound stimuli. METHODS: A systematic review of tinnitus Residual Inhibition (RI) studies was performed, focusing on prevalence, methods used, stimuli presented and responses obtained. A literature search (PubMed, Cochrane Central Register of Controlled Trials, Scopus, MEDLINE) was conducted. Seventeen studies involving 1066 patients fulfilled the inclusion criteria. Sound stimulation was performed using pure tones, customized sounds, narrow- and broadband noises, and modulated sounds. RESULTS: Sound stimuli exposure produced complete RI of tinnitus in 34.5% of patients (range 5.6-72%), with higher RI rates after stimulation with pure tones and narrowband noise centered to the tinnitus perceived pitch. RI duration tends to increase when stimuli duration increases. CONCLUSIONS: RI is frequent and can be induced by narrow-band noise (NBN), broadband noise (BBN), pure tones, customized sounds and modulated sounds. Adequate evidence to support the use of RI as a tool for tinnitus phenotyping or as a management option is pending. Further clinical research exploring the profile of patients with RI and its potential use as prognostic factor should be conducted.

Blood Prestin Levels in Normal Hearing and in Sensorineural Hearing Loss: A Scoping Review.

OBJECTIVES: Recently, it has been hypothesized that blood prestin concentration levels may reflect cochlear damage and thus serve as an easily measurable, early sensorineural hearing loss (HL) biomarker. This is a scoping review aiming to identify and critically appraise current evidence on prestin blood levels and their temporal variation in rodents and humans with normal hearing and with sensorineural HL. DESIGN: This study was designed and held according to PRISMA Extension for Scoping Reviews (PRISMA-ScR) guidelines. With no limitation with regards to study type, animal and human studies focusing on prestin blood levels in normal hearing and in sensorineural HL were sought in major databases such as Medline, Central Scopus, PROSPERO, and Clinicaltrials.gov. Results were then hand-searched. A data charting form was developed including the parameters of interest. RESULTS: Seven studies focusing on measuring prestin blood levels by means of ELISA in rodents and human subjects with normal hearing and noise-induced, drug-induced, or idiopathic sudden HL were found eligible and were included in the analysis. According to these proof-of-concept studies, prestin can be detected in the circulation of subjects with no HL; however, normal ranges remain unclear. After cochlear damage, blood prestin levels seem to initially rise and then return to near or below baseline. The degree of their change relates with subjects' degree of HL, damaged cochlear region and recovery. Prestin blood levels and their temporal variation seem to correlate with cochlear damage; however, methodological weaknesses, such as small sample size, lack of detailed phenotyping, insufficient exclusion of confounding factors, and short follow-up, do not allow for robust conclusions. CONCLUSIONS: Current findings support the value of studying blood prestin levels in normal hearing and HL and highlight a need for larger-scale longitudinal research.

Audiological findings in professionals exposed to music and their relation with tinnitus.

Professional musicians are at high risk of developing tinnitus due to their over-exposure to music at both occupational and recreational level. This is a 5-year long prospective case series study performed in the Musicians/Performing Arts Medicine Clinic of the 1st Otorhinolaryngology Department of the National and Kapodistrian University of Athens. A total of 274 professional musicians underwent thorough medical history, history of music exposure, assessment of the impact their hearing status has on their professional life (Musicians Hearing Handicap Index), behavioral (Pure Tone Audiometry, standard and extended high frequency) and objective audiometric tests (TEOAE and DPOAE). Standard pure tone audiometry thresholds were correlated with the presence of tinnitus only at high frequencies. Musicians with tinnitus had a clinical and significant higher MHHI score and the incidence of tinnitus was significantly higher in participants suffering from musculoskeletal disease and those with abnormal PTA. Participants' hours of practice were similar in those with tinnitus and those without. The tinnitus group (and in order of descending effect size) had significantly worse thresholds in high frequency audiometry (≥3000Hz) as well as lower signal to noise ratios in DPOAE at almost all frequencies and in TEOAE at high frequencies (2.8 and 4kHz). A subgroup analysis of the musicians with normal PTA, showed that those with tinnitus showed elevated thresholds in the extended high frequency. In conclusion, tinnitus occurrence in musicians with normal audiogram is potentially correlated with high frequency hearing loss and impaired otoacoustic emissions and these two examinations should be considered in this group.

EHealth and Its Role in Supporting Audiological Rehabilitation: Patient Perspectives on Barriers and Facilitators of Using a Personal Hearing Support System With Mobile Application as Part of the EVOTION Study.

BACKGROUND: Hearing loss is a major public health challenge. Audiology services need to utilise a range of rehabilitative services and maximise innovative practice afforded by technology to actively promote personalized, participatory, preventative and predictive care if they are to cope with the social and economic burden placed on the population by the rapidly rising prevalence of hearing loss. Digital interventions and teleaudiology could be a key part of providing high quality, cost-effective, patient-centred management. There is currently very limited evidence that assesses the hearing impaired patient perspective on the acceptance and usability of this type of technology. AIM: This study aims to identify patient perceptions of the use of a hearing support system including a mobile smartphone app when used with Bluetooth-connected hearing aids across the everyday life of users, as part of the EVOTION project. METHODS: We applied a questionnaire to 564 participants in three countries across Europe and analysed the following topics: connectivity, hearing aid controls, instructional videos, audiological tests and auditory training. KEY FINDINGS: Older users were just as satisfied as younger users when operating this type of technology. Technical problems such as Bluetooth connectivity need to be minimised as this issue is highly critical for user satisfaction, engagement and uptake. A system that promotes user-controllability of hearing aids that is more accessible and easier to use is highly valued. Participants are happy to utilise monitoring tests and auditory training on a mobile phone out of the clinic but in order to have value the test battery needs to be relevant and tailored to each user, easy to understand and use. Such functions can elicit a negative as well as positive experience for each user. CONCLUSION: Older and younger adults can utilise an eHealth mobile app to complement their rehabilitation and health care. If the technology works well, is tailored to the individual and in-depth personalised guidance and support is provided, it could assist maximisation of hearing aid uptake, promotion of self-management and improving outcomes.

Musicians' Hearing Handicap Index: A New Questionnaire to Assess the Impact of Hearing Impairment in Musicians and Other Music Professionals.

Purpose We aimed to develop and validate the Musicians' Hearing Handicap Index (MHHI), a new self-evaluation tool for quantifying occupation-related auditory difficulties in music professionals. Although pure-tone audiometry is often considered the "gold standard" and is usually employed as the main instrument for hearing assessment, it cannot fully describe the impact of hearing dysfunction. The MHHI is an attempt to complement the hearing impairment assessment toolbox and is based on a unique approach to quantify the effects of hearing-related symptoms or hearing loss on the performance of musicians and other music industry professionals. Method An initial set of 143 questionnaire items was successively refined through a series of critical appraisals, modifications, and suggestions. This yielded an intermediate questionnaire consisting of 43 items, which was administered to 204 musicians and sound engineers. After exploratory factor analysis, the final form of the MHHI questionnaire was obtained, consisting of 29 items. The questionnaire's test-retest reliability, internal consistency, discriminating power, content validity, criterion validity, and aspects of construct validity and inherent conceptual structure were assessed. Results Exploratory factor analysis revealed a combination of four common factors for the 29 validated questionnaire items. They were named "impact on social and working lives," "difficulties in performance and sound perception," "communication difficulties," and "emotional distress." The MHHI was shown to be a valid and reliable instrument to assess musicians' and sound engineers' occupational difficulties due to hearing impairment and related symptoms. Conclusion The ability of the MHHI to discriminate between groups of music professionals with different auditory symptoms or pure-tone audiometry thresholds suggests that auditory symptoms might influence a professional's performance to an extent that cannot be assessed by a pure-tone audiogram.

A Dynamic Bayesian Network Approach to Behavioral Modelling of Elderly People during a Home-based Augmented Reality Balance Physiotherapy Programme.

In this study, we propose a dynamic Bayesian network (DBN)-based approach to behavioral modelling of community dwelling older adults at risk for falls during the daily sessions of a hologram-enabled vestibular rehabilitation therapy programme. The component of human behavior being modelled is the level of frustration experienced by the user at each exercise, as it is assessed by the NASA Task Load Index. Herein, we present the topology of the DBN and test its inference performance on real-patient data.Clinical Relevance- Precise behavioral modelling will provide an indicator for tailoring the rehabilitation programme to each individual's personal psychological needs.

Tinnitus healthcare: a survey revealing extensive variation in opinion and practices across Europe.

Tinnitus remains a scientific and clinical problem whereby, in spite of increasing knowledge on effective treatment and management for tinnitus, very little impact on clinical practice has been observed. There is evidence that prolonged, obscure and indirect referral trajectories persist in usual tinnitus care. OBJECTIVE: It is widely acknowledged that efforts to change professional practice are more successful if barriers are identified and implementation activities are systematically tailored to the specific determinants of practice. The aim of this study was to administer a health service evaluation survey to scope current practice and knowledge of standards in tinnitus care across Europe. The purpose of this survey was to specifically inform the development process of a European clinical guideline that would be implementable in all European countries. DESIGN: A health service evaluation survey was carried out. SETTING: The survey was carried out online across Europe. PARTICIPANTS: Clinical experts, researchers and policy-makers involved in national tinnitus healthcare and decision-making. OUTCOME MEASURES: A survey was developed by the study steering group, piloted on clinicians from the TINNET network and underwent two iterations before being finalised. The survey was then administered to clinicians and policy-makers from 24 European countries. RESULTS: Data collected from 625 respondents revealed significant differences in national healthcare structures, use of tinnitus definitions, opinions on characteristics of patients with tinnitus, assessment procedures and particularly in available treatment options. Differences between northern and eastern European countries were most notable. CONCLUSIONS: Most European countries do not have national clinical guidelines for the management of tinnitus. Reflective of this, clinical practices in tinnitus healthcare vary dramatically across countries. This equates to inequities of care for people with tinnitus across Europe and an opportunity to introduce standards in the form of a European clinical guideline. This survey has highlighted important barriers and facilitators to the implementation of such a guideline.

Clinical validation of a public health policy-making platform for hearing loss (EVOTION): protocol for a big data study.

INTRODUCTION: The holistic management of hearing loss (HL) requires an understanding of factors that predict hearing aid (HA) use and benefit beyond the acoustics of listening environments. Although several predictors have been identified, no study has explored the role of audiological, cognitive, behavioural and physiological data nor has any study collected real-time HA data. This study will collect 'big data', including retrospective HA logging data, prospective clinical data and real-time data via smart HAs, a mobile application and biosensors. The main objective is to enable the validation of the EVOTION platform as a public health policy-making tool for HL. METHODS AND ANALYSIS: This will be a big data international multicentre study consisting of retrospective and prospective data collection. Existing data from approximately 35 000 HA users will be extracted from clinical repositories in the UK and Denmark. For the prospective data collection, 1260 HA candidates will be recruited across four clinics in the UK and Greece. Participants will complete a battery of audiological and other assessments (measures of patient-reported HA benefit, mood, cognition, quality of life). Patients will be offered smart HAs and a mobile phone application and a subset will also be given wearable biosensors, to enable the collection of dynamic real-life HA usage data. Big data analytics will be used to detect correlations between contextualised HA usage and effectiveness, and different factors and comorbidities affecting HL, with a view to informing public health decision-making. ETHICS AND DISSEMINATION: Ethical approval was received from the London South East Research Ethics Committee (17/LO/0789), the Hippokrateion Hospital Ethics Committee (1847) and the Athens Medical Center's Ethics Committee (KM140670). Results will be disseminated through national and international events in Greece and the UK, scientific journals, newsletters, magazines and social media. Target audiences include HA users, clinicians, policy-makers and the general public. TRIAL REGISTRATION NUMBER: NCT03316287; Pre-results.

Translation and validation of the dizziness handicap inventory in Greek language.

OBJECTIVE: The aim of the study was to test the reliability and validity of the Dizziness Handicap Inventory in the Greek language (DHI). DESIGN: This study was performed in a university tertiary centre. Internal consistency was estimated using Cronbach's alpha for the DHI, physical (DHI-P), functional (DHI-F) and emotional (DHI-E) subscale scores. Correlation between DHI (total and subscales) and the SOT (sensory organisation test) as well as correlation between the DHI and FGA (functional gait assessment) was tested using Spearman's correlation coefficient. Test-retest reliability was tested using ICC (Intraclass Correlation Coefficient). SAMPLE SIZE: Ninety (90) patients were included in the study. RESULTS: Internal consistency was excellent for the total score and very good for the physical functional and emotional subscale scores. No statistically significant correlation was found between SOT and DHI. There was a moderate correlation between FGA and total DHI scores (r = -0.472; p < 0.0001) and poor to moderate between FGA and DHI subscale scores (DHI-E r1 = -0.342; p1 = 0.001, DHI-F r2 = -0.448 p2 < 0.0001, DHI-P r3 = -0.472 p3 < 0.0001). Test-retest reliability was excellent. CONCLUSION: Greek version of DHI is recommended as a valid measure for patients with vestibular disorders.

EMBalance - validation of a decision support system in the early diagnostic evaluation and management plan formulation of balance disorders in primary care: study protocol of a feasibility randomised controlled trial.

BACKGROUND: Balance problems are caused by multiple factors and often lead to falls and related fractures, bringing large socio-economic costs. The complexity of balance control mechanisms, the lack of medical expertise, and the absence of specialised equipment contribute to the delayed or incorrect diagnosis and management ofthese patients. Advances in computer science have allowed the development of computer systems that support clinical diagnosis and treatment decisions based on individualised patient data. The aim of the EMBalance decision support system (DSS) is to support doctors facing this clinical challenge, to make a definitive diagnosis and implement an effective management plan. The EMBalance study will determine the accuracy of this supportive tool when used by non-specialist doctors. This study is funded by the European Union's Seventh Framework Programme. METHODS/DESIGN: EMBalance is a proof-of-concept study designed as a non-commercial, international, multi-centre, single-blind, parallel-group randomised controlled trial to be carried out at four clinical sites in the United Kingdom, Germany, Greece and Belgium. The study is comprised of three stages: internal pilot, phase I (diagnosis) and stage II (management). For this purpose, 200 patients presenting with persistent dizziness (>3 months' duration) to primary care services will be randomised to either the intervention group (diagnostic assessment with the DSS) or a control group (diagnostic assessment without the DSS). Patients allocated to the intervention group will be assessed by a doctor with the support of the EMBalance DSS, while patients allocated to the control group will receive a visit as per standard practice. Ultimately, all patients' diagnoses and management plans will be certified by a consultant in neuro-otology. DISCUSSION: EMBalance is the first trial to test the accuracy of a DSS in both the diagnosis of and the management plan for vestibular disorders across the healthcare systems of four different countries. The EMBalance study is the result of a combined effort of engineers and physicians to develop an accurate tool to support non-specialist doctors, with no risk for the patient. This trial will provide reliable information about the benefits of implementing DSSs in primary care while supporting the feasibility of testing the EMBalance algorithms in further research. TRIAL REGISTRATION: ClinicalTrials.gov NCT02704819 . Registered 29 February 2016.

Management and modeling of balance disorders using decision support systems: the EMBALANCE project.

In this work, we present the concept, the methodological ideas and the architecture of the EMBALANCE platform. EMBALANCE platform extends existing but generic and currently uncoupled balance modeling activities, leading to a multi-scale and patient-specific balance Hypermodel, which is incorporated to a Decision Support System (DSS), towards the early diagnosis, prediction and the efficient treatment planning of balance disorders. Various data feed the intelligent system increasing the dimensionality and personalization of the system. Human Computer Interaction techniques are utilized in order to develop the required interfaces in a user-intuitive and efficient way, while interoperable web services enhance the accessibility and acceptance of the system. The platform will be validated using both retrospective as well as prospective experimental and clinical data. The final tool will be a powerful web-based platform provided to primary and secondary care physicians across specialties, levels of training and geographical boundaries, targeting wider clinical acceptance as well as the increased confidence in the developed DSS towards the early diagnostic evaluation, behaviour prediction and effective management planning of balance problems. Currently we focus and present the management and modeling of the balance disorders.

Effect of modeling parameters on the frequency response of the middle ear by means of finite element analysis.

A 3D finite element model of the human middle ear was developed for the investigation of the modeling parameters' effect on the frequency response. In this study, we incorporated realistic reconstructed geometries from microCT imaging data. The geometric representation of the stapedial annular ligament provided additional damping and the Rayleigh parameter ß was adjusted to lower values in comparison to previous computational studies. The maximum displacement of the stapes footplate, equal to 0.168 µm, was observed at a frequency of 1050 Hz. The computational results were validated with experimental measurements. Good agreement is observed between our results and the experimental data and other finite element studies.