Tinnitus is the perception of a phantom sound and the patient's reaction to it. Although much... more Tinnitus is the perception of a phantom sound and the patient's reaction to it. Although much progress has been made, tinnitus remains a scientific and clinical enigma of high prevalence and high economic burden, with an estimated prevalence of 10%-20% among the adult population. The EU is funding a new collaborative project entitled "Unification of Treatments and Interventions for Tinnitus Patients" (UNITI, grant no. 848261) under its Horizon 2020 framework. The main goal of the UNITI project is to set the ground for a predictive computational model based on existing and longitudinal data attempting to address the question of which treatment or combination of treatments is optimal for a specific patient group based on certain parameters. Clinical, epidemiological, genetic and audiological data, including signals reflecting ear-brain communication, as well as patients' medical history, will be analyzed making use of existing databases. Predictive factors for different patient groups will be extracted and their prognostic relevance validated through a Randomized Clinical Trial (RCT) in which different patient groups will undergo a combination of tinnitus therapies targeting both auditory and central nervous systems. From a scientific point of view, the UNITI project can be summarized into the following research goals: (1) Analysis of existing data: Results of existing clinical studies will be analyzed to identify subgroups of patients with specific treatment responses and to identify systematic differences between the patient groups at the participating clinical centers. (2) Genetic and blood biomarker analysis: High throughput Whole Exome Sequencing (WES) will be performed in well-characterized chronic tinnitus cases, together with Proximity Extension Assays (PEA) for the identification of blood biomarkers for tinnitus. (3) RCT: A total of 500 patients will be recruited at five clinical centers across Europe comparing single treatments against combinational treatments. The four main treatments are Cognitive Behavioral Therapy (CBT), hearing aids, sound stimulation, and structured counseling. The consortium will also make use of e/m-health applications for the treatment and assessment of tinnitus. (4) Decision Support System: An innovative Decision Support System will be implemented, integrating all available parameters (epidemiological, clinical, audiometry, genetics, socioeconomic and medical history) to suggest specific examinations and the optimal intervention strategy based on the collected data. (5) Financial estimation analysis: A cost-effectiveness analysis for the respective interventions will be calculated to investigate the economic effects of the interventions based on quality-adjusted life years. In this paper, we will present the UNITI project, the scientific questions that it aims to address, the research consortium, and the organizational structure.
This article is an open access article distributed under the terms and conditions of the Creative... more This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY
Background Tinnitus is a leading cause of disease burden globally. Several therapeutic strategies... more Background Tinnitus is a leading cause of disease burden globally. Several therapeutic strategies are recommended in guidelines for the reduction of tinnitus distress; however, little is known about the potential increased effectiveness of a combination of treatments and personalized treatments for each tinnitus patient. Methods Within the Uni cation of Treatments and Interventions for Tinnitus Patients project, a multicenter, randomized clinical trial is conducted with the aim to compare the effectiveness of single treatments and combined treatments on tinnitus distress (UNITI-RCT). Five different tinnitus centers across Europe aim to treat chronic tinnitus patients with either cognitive behavior therapy, sound therapy, structured counseling, or hearing aids alone, or with a combination of two of these treatments, resulting in 4 treatment arms with single treatment and 6 treatment arms with combinational treatment. This statistical analysis plan describes the statistical methods to be deployed in the UNITI-RCT. Discussion The UNITI-RCT trial will provide important evidence about whether a combination of treatments is superior to a single treatment alone in the management of chronic tinnitus patients. This pre-speci ed statistical analysis plan details the methodology for the analysis of the UNITI trial results. Trial registration ClinicalTrials.gov NCT04663828 (https://clinicaltrials.gov/ct2/show/NCT04663828). The trial is ongoing. Date of registration: December 11, 2020. The main RCT analyses will start by the end of December 2022 and will include data from patients who have nished their treatment by the 19th of December 2022.
Current evidence on efficacy of hearing aids (HAs) on tinnitus perception and annoyance is consid... more Current evidence on efficacy of hearing aids (HAs) on tinnitus perception and annoyance is considered insufficient due to the heterogeneity of tinnitus characteristics and of methods used in the relevant clinical studies. This is a scoping review focused on the methodological aspects of clinical studies evaluating the value of HA fitting as part of tinnitus management over the past 10 years. Thirty-four studies were included in the review, showing important heterogeneity in almost all aspects of inclusion criteria, comparators, outcome measures, follow-up time and HA fitting procedures. Although all studies show that HA fitting has a positive impact on tinnitus perception in patients with hearing loss, the methodological heterogeneity does not allow robust conclusions. Future studies taking into account the different nature and goals of each tinnitus therapeutic modality and adapting their methods, endpoints and timelines according to them could lay the groundwork for obtaining high...
Professional musicians are at high risk of developing tinnitus due to their over-exposure to musi... more 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.
Background Tinnitus represents a relatively common condition in the global population accompanied... more Background Tinnitus represents a relatively common condition in the global population accompanied by various comorbidities and severe burden in many cases. Nevertheless, there is currently no general treatment or cure, presumable due to the heterogeneity of tinnitus with its wide variety of etiologies and tinnitus phenotypes. Hence, most treatment studies merely demonstrated improvement in a subgroup of tinnitus patients. The majority of studies are characterized by small sample sizes, unstandardized treatments and assessments, or applications of interventions targeting only a single organ level. Combinatory treatment approaches, potentially targeting multiple systems as well as treatment personalization, might provide remedy and enhance treatment responses. The aim of the present study is to systematically examine established tinnitus therapies both alone and in combination in a large sample of tinnitus patients. Further, it wants to provide the basis for personalized treatment app...
Journal of Speech, Language, and Hearing Research, 2020
Purpose We aimed to develop and validate the Musicians' Hearing Handicap Index (MHHI), a new ... more 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 questio...
Tinnitus is the perception of a phantom sound and the patient's reaction to it. Although much... more Tinnitus is the perception of a phantom sound and the patient's reaction to it. Although much progress has been made, tinnitus remains a scientific and clinical enigma of high prevalence and high economic burden, with an estimated prevalence of 10%-20% among the adult population. The EU is funding a new collaborative project entitled "Unification of Treatments and Interventions for Tinnitus Patients" (UNITI, grant no. 848261) under its Horizon 2020 framework. The main goal of the UNITI project is to set the ground for a predictive computational model based on existing and longitudinal data attempting to address the question of which treatment or combination of treatments is optimal for a specific patient group based on certain parameters. Clinical, epidemiological, genetic and audiological data, including signals reflecting ear-brain communication, as well as patients' medical history, will be analyzed making use of existing databases. Predictive factors for different patient groups will be extracted and their prognostic relevance validated through a Randomized Clinical Trial (RCT) in which different patient groups will undergo a combination of tinnitus therapies targeting both auditory and central nervous systems. From a scientific point of view, the UNITI project can be summarized into the following research goals: (1) Analysis of existing data: Results of existing clinical studies will be analyzed to identify subgroups of patients with specific treatment responses and to identify systematic differences between the patient groups at the participating clinical centers. (2) Genetic and blood biomarker analysis: High throughput Whole Exome Sequencing (WES) will be performed in well-characterized chronic tinnitus cases, together with Proximity Extension Assays (PEA) for the identification of blood biomarkers for tinnitus. (3) RCT: A total of 500 patients will be recruited at five clinical centers across Europe comparing single treatments against combinational treatments. The four main treatments are Cognitive Behavioral Therapy (CBT), hearing aids, sound stimulation, and structured counseling. The consortium will also make use of e/m-health applications for the treatment and assessment of tinnitus. (4) Decision Support System: An innovative Decision Support System will be implemented, integrating all available parameters (epidemiological, clinical, audiometry, genetics, socioeconomic and medical history) to suggest specific examinations and the optimal intervention strategy based on the collected data. (5) Financial estimation analysis: A cost-effectiveness analysis for the respective interventions will be calculated to investigate the economic effects of the interventions based on quality-adjusted life years. In this paper, we will present the UNITI project, the scientific questions that it aims to address, the research consortium, and the organizational structure.
This article is an open access article distributed under the terms and conditions of the Creative... more This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY
Background Tinnitus is a leading cause of disease burden globally. Several therapeutic strategies... more Background Tinnitus is a leading cause of disease burden globally. Several therapeutic strategies are recommended in guidelines for the reduction of tinnitus distress; however, little is known about the potential increased effectiveness of a combination of treatments and personalized treatments for each tinnitus patient. Methods Within the Uni cation of Treatments and Interventions for Tinnitus Patients project, a multicenter, randomized clinical trial is conducted with the aim to compare the effectiveness of single treatments and combined treatments on tinnitus distress (UNITI-RCT). Five different tinnitus centers across Europe aim to treat chronic tinnitus patients with either cognitive behavior therapy, sound therapy, structured counseling, or hearing aids alone, or with a combination of two of these treatments, resulting in 4 treatment arms with single treatment and 6 treatment arms with combinational treatment. This statistical analysis plan describes the statistical methods to be deployed in the UNITI-RCT. Discussion The UNITI-RCT trial will provide important evidence about whether a combination of treatments is superior to a single treatment alone in the management of chronic tinnitus patients. This pre-speci ed statistical analysis plan details the methodology for the analysis of the UNITI trial results. Trial registration ClinicalTrials.gov NCT04663828 (https://clinicaltrials.gov/ct2/show/NCT04663828). The trial is ongoing. Date of registration: December 11, 2020. The main RCT analyses will start by the end of December 2022 and will include data from patients who have nished their treatment by the 19th of December 2022.
Current evidence on efficacy of hearing aids (HAs) on tinnitus perception and annoyance is consid... more Current evidence on efficacy of hearing aids (HAs) on tinnitus perception and annoyance is considered insufficient due to the heterogeneity of tinnitus characteristics and of methods used in the relevant clinical studies. This is a scoping review focused on the methodological aspects of clinical studies evaluating the value of HA fitting as part of tinnitus management over the past 10 years. Thirty-four studies were included in the review, showing important heterogeneity in almost all aspects of inclusion criteria, comparators, outcome measures, follow-up time and HA fitting procedures. Although all studies show that HA fitting has a positive impact on tinnitus perception in patients with hearing loss, the methodological heterogeneity does not allow robust conclusions. Future studies taking into account the different nature and goals of each tinnitus therapeutic modality and adapting their methods, endpoints and timelines according to them could lay the groundwork for obtaining high...
Professional musicians are at high risk of developing tinnitus due to their over-exposure to musi... more 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.
Background Tinnitus represents a relatively common condition in the global population accompanied... more Background Tinnitus represents a relatively common condition in the global population accompanied by various comorbidities and severe burden in many cases. Nevertheless, there is currently no general treatment or cure, presumable due to the heterogeneity of tinnitus with its wide variety of etiologies and tinnitus phenotypes. Hence, most treatment studies merely demonstrated improvement in a subgroup of tinnitus patients. The majority of studies are characterized by small sample sizes, unstandardized treatments and assessments, or applications of interventions targeting only a single organ level. Combinatory treatment approaches, potentially targeting multiple systems as well as treatment personalization, might provide remedy and enhance treatment responses. The aim of the present study is to systematically examine established tinnitus therapies both alone and in combination in a large sample of tinnitus patients. Further, it wants to provide the basis for personalized treatment app...
Journal of Speech, Language, and Hearing Research, 2020
Purpose We aimed to develop and validate the Musicians' Hearing Handicap Index (MHHI), a new ... more 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 questio...
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