Marzena Mielczarek

Toward a Global Consensus on Outcome Measures for Clinical Trials in Tinnitus: Report From the First International Meeting of the COMiT Initiative, November 14, 2014, Amsterdam, The Netherlands

In Europe alone, over 70 million people experience tinnitus; for seven million people, it creates a debilitating condition. Despite its enormous socioeconomic relevance, progress in successfully treating the condition is somewhat limited. The European Union has approved funding to create a pan-European tinnitus research collaboration network (2014–2018). The goal of one working group is to establish an international standard for outcome measurements in clinical trials of tinnitus. Importantly, this would enhance tinnitus research by informing sample-size calculations, enabling meta-analyses, and facilitating the identification of tinnitus subtypes, ultimately leading to improved treatments. The first meeting followed a workshop on “Agreed Standards for Measurement: An International Perspective” with invited talks on clinimetrics and existing international initiatives to define core sets for outcome measurements in hearing loss (International classification of functioning, disability, and health core sets for hearing loss) and eczema (Harmonizing outcome measures for eczema). Both initiatives have taken an approach that clearly distinguishes the specification of what to measure from that of how to measure it. Meeting delegates agreed on taking a step-wise roadmap for which the first output would be a consensus on what outcome domains are essential for all trials. The working group seeks to embrace inclusivity and brings together clinicians, tinnitus researchers, experts on clinical research methodology, statisticians, and representatives of the health industry. People who experience tinnitus are another important participant group. This meeting report is a call to those stakeholders across the globe to actively participate in the initiative.

The application of direct current electrical stimulation of the ear and cervical spine kinesitherapy in tinnitus treatment

OBJECTIVE The aim of the study was to evaluate the effectiveness of electrical stimulations of the hearing organ in tinnitus treatment adapting the frequency of stimulation according to tinnitus frequency, to assess the influence of cervical spine kinesitherapy on tinnitus, as well as to evaluate hearing after electrical stimulations alone and together with cervical spine kinesitherapy. METHODS The study comprised 80 tinnitus, sensorineural hearing loss patients (119 tinnitus ears) divided into two groups. In group I (n - 58 tinnitus ears) electrical stimulation of the hearing organ was performed, in group II (n - 61 tinnitus ears) electrical stimulation together with cervical spine kinesitherapy. Hydrotransmissive, selective electrical stimulations were conducted using direct, rectangular current. The passive electrode was placed on the forehead, the active--a silver probe--was immersed in the external ear canal in 0.9% saline solution. The treatment involved fifteen applications of electrical stimulations (each lasted for 4 min) administered three or four times a week (whole treatment lasted approximately 30 days). The evaluation of the results considered a case history (change from permanent to temporary tinnitus), questionnaires (the increase/decrease of the total points) and the audiometric evaluation of hearing level. RESULTS Before the treatment, group I comprised 51 ears (87.93%) with permanent, and 7 ears (12.07%) with temporary tinnitus; group II - 55 ears (90.17%) with permanent and 6 ears (9.83%) with temporary tinnitus. After the treatment, in both groups the number of ears with permanent tinnitus decreased considerably obtaining the pauses or disappearing of tinnitus. Directly after the treatment, group I comprised 25 ears (43.11%) with permanent, and 10 ears (17.24%) with temporary tinnitus, in 23 ears (39.65%) tinnitus disappeared; group II - 33 ears (54.1%) with permanent and 11 ears (18.03%) with temporary tinnitus, in 17 ears (27.87%) tinnitus disappeared. Regarding questionnaires, improvement was observed in group I - in 43.11% of ears, in group II - 32.8%. In both groups audiometric improvement of hearing was recognized. CONCLUSIONS (1) Electrical stimulation of the hearing organ, with the application of current frequencies according to tinnitus frequencies (selective electrical stimulation), was an efficient method in severe tinnitus treatment. (2) Cervical spine kinesitherapy in the treatment of tinnitus, using electrical stimulation, did not have any supporting influence.

GJB2 sequencing in deaf and profound sensorineural hearing loss children.

INTRODUCTION GJB2 mutations are the most frequent reason of genetic congenital hearing loss. The aim of the study was to assess the prevalence of GJB2 mutations in the deaf and profound hearing loss children. MATERIAL AND METHODS The material of the study was a group of 61 patients divided into two groups. Group I - 35 deaf or with profound sensorineural hearing loss children (the pupils of the deaf and hard of hearing school), aged 5-17 years (average 9.2 years), 14 males, 21 females, II - control group comprised 26 normal hearing patients, aged 5-16 years (average 10.4years), 14 males, 12 females (patients of Department of Pediatric Otolaryngology, Audiology and Phoniatrics, Medical University of Lodz). In both groups, exon 2 sequencing of GJB2 gene was performed. RESULTS In group I in 6 patients (17%) 35delG in GJB2 gene was found. The patients were homozygotes, with negative family history of hearing loss. No other mutations in GJB2 gene were found. In group II no mutations in GJB2 were observed. CONCLUSIONS The most frequent cause of hearing impairment in the deaf and profound sensorineural hearing loss children was 35delG mutation in GJB2 gene. No other mutations in GJB2 gene were detected.

An Increase in Alpha Band Frequency in Resting State EEG after Electrical Stimulation of the Ear in Tinnitus Patients—A Pilot Study

In our clinic invasive transtympanal promontory positive DC stimulations were first used, with a success rate of 42%. However, non-invasive hydrotransmissive negative DC stimulations are now favored, with improvement being obtained in 37.8% directly after the treatment, and 51.3% in a follow up 1 month after treatment. The further improvement after 1 month may be due to neuroplastic changes at central level as a result of altered peripheral input. The aim of the study was to determine how/whether a single electrical stimulation of the ear influences cortical activity, and whether changes observed in tinnitus after electrical stimulation are associated with any changes in cortical activity recorded in EEG. The study included 12 tinnitus patients (F–6, M-6) divided into two groups. Group I comprised six patients with unilateral tinnitus - unilateral, ipsilateral ES was performed. Group II comprised six patients with bilateral tinnitus—bilateral ES was performed. ES was performed using a custom-made apparatus. The active, silver probe—was immersed inside the external ear canal filled with saline. The passive electrode was placed on the forehead. The stimulating frequency was 250 Hz, the intensity ranged from 0.14 to 1.08 mA. The voltage was kept constant at 3 V. The duration of stimulation was 4 min. The EEG recording (Deymed QEST 32) was performed before and after ES. The patients assessed the intensity of tinnitus on the VAS 1-10. Results: In both groups an improvement in VAS was observed—in group I—in five ears (83.3%), in group II—in seven ears (58.3%). In Group I, a significant increase in the upper and lower limit frequency of alpha band was observed in the central temporal and frontal regions following ES. These changes, however, were not correlated with improvement in tinnitus. No significant changes were observed in the beta and theta bands and in group II. Preliminary results of our research reveal a change in cortical activity after electrical stimulations of the ear. However, it remains unclear if it is primary or secondary to peripheral auditory excitation. No similar studies had been found in the literature.

Elektrostymulacja jako alternatywna metoda leczenia szumów usznych

Summary Introduction The aim of the study was to evaluate the influence of the selective electrical stimulation of the hearing organ on tinnitus in people with sensorineural hearing loss. Material and methods The study comprised 248 tinnitus patients treated by using electrical stimulation. The material was divided into two groups, regarding the method of stimulation. In group I – 168 people, transtympanal electrical stimulation of the promontory was applied, whereas in group II – 80 people, hydrotransmissive technique was used. ENT examination, audiological and radiological diagnostics, as well as the evaluation of the audiometric parameters of tinnitus was performed. The patients were asked to fill in the questionnaire concerning tinnitus. In 80 patients hydrotransmissive electrical stimulation was conducted using the own prototype device, in 168 patients – transtympanal stimulation, after local anaesthesia with Xylocain gel. Results On the whole, in group of 248 patients, subjective improvement (decrease in the severity of tinnitus) was noticed in 130 people (52.4%), comprising 32 cases (13%) of total relief. In 93 patients (37.5%) tinnitus remained unchanged, and in 25 (10.1%) the deterioration was observed. The comparison of the results of two electrical stimulation methods, showed the superiority of hydrotransmissive one (improvement in 58.75% of patients), however, the number of cases of total relief was greater in the case of transtympanal method (15.5%). Considering subjective evaluation, as well as audiometric (the intensity and the frequency parameters, MML) the hydrotransmissive method appeared to be more effective (improvement in 53.75%) comparing to transtympanal stimulation (improvement in 44.6%). Conclusions On the basis of studies conducted in the Clinic and the long history of the electrical stimulation administration in tinnitus treatment, it can be stated that this method may by applied in cases, in which other therapeutical methods failed.

Hydrotransmisyjna elektrostymulacja narządu słuchu w leczeniu szumów usznych

Summary Introduction The aim of the study was to evaluate the influence of electrical stimulation on severe tinnitus. Material and methods The study comprised 46 patients (66 ears) suffering from severe tinnitus, persistently or temporarily, 27 women and 19 men, ranging in age from 22 to 84 years, on average 55. The material was divided into two groups. Group I was treated using electrical stimulation, whereas group II was being applied additionally the kinesitherapy of the cervical part of the vertebral column. The average duration of tinnitus was similar in both groups and equals 4.5 years. All the patients were administered medicines, without expected result. Otolaryngological, audiological diagnostics was conducted as well as head and cervical computer tomography. The patients were asked to fill in the questionnaire concerning tinnitus. The electrical stimulation was performed using silver electrode which was dipped in saline solution in external auditory canal. Direct current was used, the intensity ranged from 0.15 mA to 1.15 mA. Fifteen electrical stimulations were entire treatment administered twice or three times a week. Before and after treatment the subjective evaluation of tinnitus was made. Results The subjective improvement was noticed in 36 people (n 46 ears – 71%). Persistent tinnitus was registered in 30 ears and temporary in 30 ears, in 6 tinnitus disappeared completely. On the basis of audiometric tests improvement was noticed in 33 ears (55%). In group I in 17 ears (44%) – in 4 ears tinnitus disappeared, in 13 partial relief was noticed, 10 ears were without any change and in 12 ears the intensification of tinnitus was recognized. In group II in 16 ears improvement was observed, in 2 of them tinnitus disappeared, in 14 decreased. In 9 ears no change was obtained and in 2 intensification was noticed. Conclusions Electrical stimulation can be an alternative therapy in severe tinnitus treatment. The administration of kinesitherapy of cervical column may have an additive effect on tinnitus treatment.INTRODUCTION The aim of the study was to evaluate the influence of electrical stimulation on severe tinnitus. MATERIAL AND METHODS The study comprised 46 patients (66 ears) suffering from severe tinnitus, persistently or temporarily, 27 women and 19 men, ranging in age from 22 to 84 years, on average 55. The material was divided into two groups. Group I was treated using electrical stimulation, whereas group II was being applied additionally the kinesitherapy of the cervical part of the vertebral column. The average duration of tinnitus was similar in both groups and equals 4.5 years. All the patients were administered medicines, without expected result. Otolaryngological, audiological diagnostics was conducted as well as head and cervical computer tomography. The patients were asked to fill in the questionnaire concerning tinnitus. The electrical stimulation was performed using silver electrode which was dipped in saline solution in external auditory canal. Direct current was used, the intensity ranged from 0.15 mA to 1.15 mA. Fifteen electrical stimulations were entire treatment administered twice or three times a week. Before and after treatment the subjective evaluation of tinnitus was made. RESULTS The subjective improvement was noticed in 36 people (n 46 ears--71%). Persistent tinnitus was registered in 30 ears and temporary in 30 ears, in 6 tinnitus disappeared completely. On the basis of audiometric tests improvement was noticed in 33 ears (55%). In group I in 17 ears (44%)--in 4 ears tinnitus disappeared, in 13 partial relief was noticed, 10 ears were without any change and in 12 ears the intensification of tinnitus was recognized. In group II in 16 ears improvement was observed, in 2 of them tinnitus disappeared, in 14 decreased. In 9 ears no change was obtained and in 2 intensification was noticed. CONCLUSIONS Electrical stimulation can be an alternative therapy in severe tinnitus treatment. The administration of kinesitherapy of cervical column may have an additive effect on tinnitus treatment.

Excitation of the Auditory System as a Result of Non-invasive Extra-Cochlear Stimulation in Normal Subjects and Tinnitus Patients

One of possible approach that may suppress tinnitus is electrical stimulation of the ear. At first invasive techniques were used (promontory or round window stimulation), nowadays a non-invasive method, namely hydrotransmissive electric stimulation (ES) through external acoustic canal, has been developed. The aim of the study is to investigate the effect of applying ES with positive and negative current polarities on the ears of healthy subjects and on the tinnitus ears of patients with tinnitus. This comparison further clarifies the mechanisms of operation of non-invasive extra-cochlear ear ES. A second aim is to assess the effects of ES on tinnitus in tinnitus patients. The material was composed of two groups: tinnitus group—49 patients suffering from tinnitus, and healthy students group—34 healthy individuals. ES was performed with the use of a custom-made apparatus. The active, silver probe–was immersed inside saline filling external ear canal. The passive electrode was placed on the forehead. Positive and next negative DC stimulation was provided with the use following frequencies: 0.25, 1, 2, 3, 4, 5, 6, 7, 8 kHz. We checked for the presence of the auditory percept (AP) and, if AP was present, the minimum current amplitude necessary to produce AP was measured. In our research both positive and negative polarities were efficient to evoke AP in the participants. This effect, however, was more pronounced for positive polarity in no tinnitus and normal hearing individuals (healthy students group). In the tinnitus group, current intensity needed to evoke AP was higher than in the healthy students group. However, comparing normal hearing vs. hearing loss patients within the tinnitus group, we did not observe the relationship between hearing threshold and current intensity evoking AP. Afterwards, we analyzed the effect of multi-frequency ES on tinnitus. It appeared to be effective in 75% of tinnitus ears (with a high score of disappearance–22%). Our study proved that extracochlear ES with positive and negative current was efficient to stimulate the auditory system. Stimulating tinnitus ears with two polarities we obtained a higher ratio of improvement (75%) comparing to positive stimulations.

Innovations in Doctoral Training and Research on Tinnitus: The European School on Interdisciplinary Tinnitus Research (ESIT) Perspective

Tinnitus is a common medical condition which interfaces many different disciplines, yet it is not a priority for any individual discipline. A change in its scientific understanding and clinical management requires a shift toward multidisciplinary cooperation, not only in research but also in training. The European School for Interdisciplinary Tinnitus research (ESIT) brings together a unique multidisciplinary consortium of clinical practitioners, academic researchers, commercial partners, patient organizations, and public health experts to conduct innovative research and train the next generation of tinnitus researchers. ESIT supports fundamental science and clinical research projects in order to: (1) advancing new treatment solutions for tinnitus, (2) improving existing treatment paradigms, (3) developing innovative research methods, (4) performing genetic studies on, (5) collecting epidemiological data to create new knowledge about prevalence and risk factors, (6) establishing a pan-European data resource. All research projects involve inter-sectoral partnerships through practical training, quite unlike anything that can be offered by any single university alone. Likewise, the postgraduate training curriculum fosters a deep knowledge about tinnitus whilst nurturing transferable competencies in personal qualities and approaches needed to be an effective researcher, knowledge of the standards, requirements and professionalism to do research, and skills to work with others and to ensure the wider impact of research. ESIT is the seed for future generations of creative, entrepreneurial, and innovative researchers, trained to master the upcoming challenges in the tinnitus field, to implement sustained changes in prevention and clinical management of tinnitus, and to shape doctoral education in tinnitus for the future.

Increased sensibility to acute acoustic and blast trauma among patients with acoustic neuroma

The article shows 2 cases of unusual presentation of acute acoustic trauma and blast injury due to occupational exposure. In the case of both patients the range of impaired frequencies in pure tone audiograms was atypical for this kind of causative factor. Both patients had symmetrical hearing before the accident (which was confirmed by provided results of hearing controls during their employment). A history of noise/blast exposure, the onset of symptoms directly after harmful exposure, symmetrical hearing before the trauma documented with audiograms, directed initial diagnosis towards acoustic/blast trauma, however, of atypical course. Acute acoustic and blast trauma and coexisting acoustic neuroma (AN) contributed to, and mutually modified, the course of sudden hearing loss. In the literature there are some reports pointing to a higher sensitivity to acoustic trauma in the case of patients with AN and, on the other hand, indicating noise as one of the causative factors in AN. Int J Occup Med Environ Health 2018;31(3):361-369.

Correlations between Apnea/Hypopnea Index and selected morphological and clinical parameters in patients with unilateral or bilateral impairment of nasal patency.

INTRODUCTION The aim of this work was to evaluate the correlation between Apnea/Hypopnea Index (AHI) and selected parameters of morphological and clinical character in the patients with a unilateral or bilateral impairment of nasal patency. MATERIAL AND METHODS The study covered 60 adults, including 37 male and 23 female subjects, 19-69 years of age. In the Department, these subjects were divided into 3 groups: I - 20 patients with unilateral impairment of nasal patency, II - 20 patients with bilateral impairment of nasal patency, III - controls with normal nasal patency. METHODOLOGY A subjective examination (questionnaire with a sleepiness scale), an objective examination (general examination of the neck and waist diameter, body weight, height, length of the uvula), otorhinolaryngological examination (Pirquet test of the palatine tonsils), X-ray and CT of the head and paranasal sinuses) to determine the cause and location of the obturation of air passages, physiological tests and polysomnography. The correlations between the neck circumferenceheight ratio (NHR) and AHI, waist-hip ratio (WHR) and AHI. The statistical analysis of the study results was conducted in Stata®/Special Edition Program, 14.1 version (StataCorp LP, College Station, Texas, USA). RESULTS Clinically, the study group revealed: shallow breathing in 47.5% and apnea in 52.5% of the studied patients whereas the control group did not show any sleep disorders. Statistical fluctuations between controls and the study groups were noticed (p<0.001). CONCLUSION By the Epworth scale, moderate and severe sleepiness was found in merely 12.5% of the patients. The differences in the length of the uvula and the size of the pharyngeal tonsils between the studied groups were not statistically significant. No statistical significance was found between NHR and AHI, BMI and AHI, WHR and AHI in the studied group.