Dupilumab in chronic rhinosinusitis with nasal polyps: Real life data in a multicentric Sicilian experience.

OBJECTIVE: This study aimed to evaluate the effectiveness and safety of dupilumab during the first year of treatment in a real-life setting, focusing on improvement in nasal polyp score (NPS) as well as specific symptoms, quality of life and olfactory function. METHODOLOGY/PRINCIPAL: A multicentric observational cohort study was carried out. A total of 170 patients were enrolled in the Otorhinolaryngology Unit of the three University Hospitals and considered for dupilumab therapy. All recorder characteristics were age (at the first dupilumab application visit), sex, smoke habits, previous local and systemic corticosteroid therapy, history of endoscopic sinus surgery, number of previous endoscopic sinus surgery, concomitant asthma, history of an allergic condition, immunoglobulin E (IgE), allergy to nonsteroidal anti-inflammatory drugs (NSAIDs), Aspirin Exacerbated Respiratory Disease (AERD), other comorbidities associated, blood eosinophils, nasal polyp score, sinonasal outcome test 22 (SNOT 22), sniffin' stick test, the start date of dupilumab therapy and number of doses of dupilumab and eventually, Dupilumab's adverse events related to administration. The Wilcoxon test for dependent samples was performed to compare variables. Statistical significance was assumed for p values < 0.05. RESULTS: A statistically significant reduction in SNOT-22 and NPS was shown at the 6th and 12th month compared to baseline values (p < 0.001 for both comparisons). A statistically significant increase value at the Sniffin' sticks test was shown in the 6th and 12th month compared to baseline values (p < 0.001 for both comparisons). At the 12-month follow-up, according to EUFOREA indications, all patients were considered to remain in treatment with dupilumab and continued the treatment because of a reduced NPS, improved quality of life and a reduced need for system corticosteroids. Dupilumab seemed to be well tolerated by all patients. Any adverse effect of the drug led to the quit of biological treatment. CONCLUSIONS: This multi-centric real-life study supported the effectiveness of dupilumab as an add-on therapy to intranasal corticosteroids in patients with severe uncontrolled CRSwNP in improvement of quality of life, severity of symptoms, polyp size reduction and smell function. Furthermore, our data support the safety profile of monoclonal therapy with dupilumab.

Extended wear hearing aids: a comparative, pilot study.

PURPOSE: The study evaluated if there were differences between three types of hearing aids, Lyric extended wear (EW), receiver-in-the-ear canal (RITE), completely-in-the-canal (CIC) hearing aids in terms of audiological and psychosocial outcomes. METHODS: Fifteen patients were selected. INCLUSION CRITERIA: Pure-Tone Average (PTA) air conduction range of hearing threshold at 500, 1000, and 2000 Hz from 15 dB HL to 75 dB HL. Patients were assigned in three groups according to the hearing aid used: Extended wear, RITE, and CIC. Pure-tone audiometry, speech audiometry, free-field pure-tone and speech audiometry with hearing aids, and Matrix sentence test were performed. The Satisfaction with Amplification in Daily Life (SADL) questionnaire and the Abbreviated Profile of Hearing Aid Benefit (APHAB) questionnaire were used to assess the psychosocial and audiological benefits provided by hearing aids. RESULTS: No differences were demonstrated in the Matrix sentence test between the groups. A statistically significant difference was present between the "Personal image" of patients with EW and RITE with a p value of 0.01 (better outcome using EW). For the APHAB questionnaire, a significant difference was present in the "Aversiveness" of the patients with EW in comparison to CIC and RITE with a p value of 0.01 (higher aversiveness of sound using EW). CONCLUSION: In terms of audiological advantage, extended ear hearing aids are similar to RITE and CIC as demonstrated from the Matrix speech reception threshold. The result was confirmed using the APHAB questionnaire. Extended wear devices are better than daily hearing aids concerning the "personal image".

Frequency-lowering processing to improve speech-in-noise intelligibility in patients with age-related hearing loss.

OBJECTIVE: Modern hearing aids use various signal-processing strategies to improve speech intelligibility. In this manuscript, we studied the linear frequency transposition (LFT), a frequency-lowering algorithm, in patients with age-related hearing loss. Frequency-lowering algorithms transpose high-frequency sounds to a lower-frequency band. The study aimed to assess whether LFT could be used as a tool to improve speech intelligibility in patients with a better high-frequency preservation. METHODS: The study population consisted of 77 patients (age average 74.8 ± 12.4) wearing hearing aids with an open or tulip coupling system with age-related hearing loss. The unaided air conduction pure tone average (PTA) at 500, 1000, 2000 Hz was 43.5 ± 14.3 dB; the unaided word recognition score (WRS) average was 53.7 ± 12.5%. We compared WRS in all patients with the hearing aid turned on, in "quiet" and using a "pink" and "babble" masking noise. Three hearing aid settings were tested in each acoustic conditions: no transposition (NT), high transposition (HT), and low transposition (LT). "High" and "low" refer to the "start frequency"; all sounds above the start frequency are transposed in a lower-frequency band. When the start frequency was suggested by the fitting software, we called the condition "high transposition"; when the start frequency was set at the lowest possible value provided by the fitting software, we called the condition "low transposition". The quality of the voice was also assessed asking the patient to give a score from 1 to 10, where 10 was the maximum listening comfort [quality of voice score (QVS)]. RESULTS: Collected data were compared for each condition (NT, HT, LT, in quiet, pink noise and babble noise) and no statistically significant differences were found in WRS and QVS (quiet WRS p = 0.07, pink noise WRS p = 0.18, babble noise WRS p = 0.11, QVS p = 0.91). We selected 33 patients with a better WRS in babble noise using transposition (high and low). In this group, the age was significantly lower than patients who did not use transposition (p = 0.01). CONCLUSION: Linear frequency transposition is not useful to improve speech-in-noise intelligibility in patients with age-related hearing loss. Despite that no statistically significant differences were found, younger people could get advantages from the LFT when babble noise disturbs the listening of speech. The use of FL algorithm as a way to improve speech intelligibility in noisy environments should be always considered.

Adenomatous Neuroendocrine Tumors of the Middle Ear in a Young Man With Conductive Hearing Loss.

ABSTRACT: Neuroendocrine neoplasms of the ear pose a diagnostic challenge because clinical symptoms are no specific. Definite diagnosis is made by histopathological analysis with immunohystochemical evalutation. Therapy consists in a complete surgical resection. Controversial terminology of the neoplasm arises from the differentiation of these tumors composed of both endocrine and exocrine glands. Middle ear localization is an extremely rare presentation but less aggressive than gastrointestinal tract or lung localizations which are the most frequent. Radio-diagnostic analyses are necessary follow-up for preventing or detecting recurrence or metastasis. The authors present a case of neuroendocrine tumor of the middle ear in a young male of 37 years old who presented unilateral right hearing loss and tinnitus. A transcanal tympanoplasty was performed. There were no intraoperative complications and the postoperative period was uneventful.

Symptomatology in head and neck district in coronavirus disease (COVID-19): A possible neuroinvasive action of SARS-CoV-2.

OBJECTIVE: The aim of this manuscript is to investigate transversally Ear Nose Throat (ENT) symptoms COVID-19 infection correlated and to study the neurotropism and neuroinvasiveness of the virus in the head-neck district through the investigation of the sense of smell, taste, tearing, salivation and hearing. METHODS: A total of 50 patients with laboratory-confirmed COVID-19 infection were included in our study. For each patient we evaluated the short version of the Questionnaire of Olfactory Disorders-Negative Statements (sQOD-NS), the Summated Xerostomia Inventory-Dutch Version (SXI-DV), The Standardized Patient Evaluation of Eye Dryness (SPEED), Schirmer test I, the Hearing Handicap Inventory For Adults (HHIA) and the Tinnitus Handicap Inventory (THI). All the tests we carried out were performed during the active phase of the symptomatology from COVID-19 (Condition A) and 15 after SARS-COV-2 RT-PCR test negative (Condition B). RESULTS: A total of 46 patients (92%) had olfactory dysfunction related to the infection. The 70% of patients reported gustatory disorders. Cough, fever, headache and asthenia were the most prevalent symptoms. There was a statistically significant difference (p < 0,001) in sQOD-NS, SXI-DV, SPEED, Schirmer test, HHIA and THI between Condition A and Condition B. CONCLUSIONS: In our population there was an alteration of the sense of taste, of the sense of smell, dry eyes and of the oral cavity and an auditory discomfort, symptoms probably linked to the neurotropism of the virus. Furthermore, anosmia, dysgeusia and xerostomia are early symptoms of COVID-19, which can be exploited for an early quarantine and a limitation of viral contagion.

Real ear measurement (REM) and auditory performances with open, tulip and double closed dome in patients using hearing aids.

OBJECTIVE: The aim of the study is to evaluate the importance of acoustic modifications generated by different commercially available ear-tips, focused on domes of receiver in the canal hearing aids using Real Ear Measurement (REM). METHODS: We enrolled 110 people selecting 200 ears bearers of hearing aids. In every patient, we performed REM and audiological tests with three different dome types: Open, Tulip and Double Closed (DC). Data about real-ear occluded gain (REOG), Pure Tone Average (PTA), Word Recognition Score (WRS) with aids switched on in Free Field, Ear and Auditory Comfort were collected and analyzed. RESULTS: REOG gain was statistically significant different between the three types of dome, with a DC that always closes the external auditory canal (EAC) (p < 0.001). There was no statistically significant difference between the PTA (p = 0.11). Regarding the WRS there were statistically significant differences between Open and DC dome (p < 0.001) and between Tulip and DC dome (p < 0.001), with worse discrimination when using DC. Both auditory and ear comfort are worse in the DC than in the other two domes (p < 0.001). From measured REOG gain values, in 135 cases Tulip dome does not occlude the EAC, with a statistically significant difference compared to DC (p < 0.001; Odd Ratio 0.0012; 95% CI 0.001-0.0196). CONCLUSION: Our study confirms the necessity to perform REM to evaluate if the prescription target is achieved, especially when tulip domes are used, because they may not occlude the ear canal, causing in some cases the reduction of the vocal discrimination.

Rhino-Orbito-Cerebral Mucormycosis in Diabetic Disease Mucormycosis in Diabetic Disease.

The authors present their experience about clinical evidences that include patients with an untreated diabetes who developed rhino-orbito-cerebral mucormycosis (ROCM). They were treated with endoscopic sinus surgery and medical treatment with intravenous, intradural therapy, and sinus washes with amphotericin B. The ROCM is a disease with a rapid evolution and an increase in mortality rate, especially if the fungus enters the cranial cavity. Therefore, it would be necessary in all diabetic patients with sinus symptoms, headaches, visual changes, suspect a mucormycosis, and perform a careful radiology assessment and a nasal endoscopy. Often, despite an early diagnosis and rapid treatment for ROCM, it is not possible to stem the disease, which ends with the patient's death.

Effect of a Mandibular Advancement Device on the Upper Airway in a Patient With Obstructive Sleep Apnea.

The authors present a case of a 33-year-old male patient with obstructive sleep apnea syndrome who was treated with a mandibular advancement device with excellent results. The aim of this study is to underline the importance of new instruments that allow evaluating the upper airway with greater precision, such as cone beam tomography. Given the diagnosis and treatment, the upper airway was assessed using cone beam tomography; an increase in UA volume of 22% was observed (initial volume 22,962 mm), along with a 28% increase in area (initial area 971 mm). The evaluation of the UA using teleradiography also showed an increase in the points evaluated, with the midpoint of the soft palate presenting the greatest increase.

A complex relation between depression and multiple sclerosis: a descriptive review.

BACKGROUND: Multiple sclerosis (MS) is a demyelinating neurodegenerative disease that affects central nervous system (CNS). MS patients are more likely to develop depressive symptoms than patients with other chronic diseases. OBJECTIVE: In this review, we have analysed if there is a correlation between brain lesions (BL), structural damage (SD) and depressive symptoms (DS). METHODS: We Searched on PubMed and Web of Science databases and screening references of included studied and some review article for additional citations. From initial 745 studies, only 9 met the inclusion criteria. All studies conducted research on 389 patients with MS associated with DS and 120 HC (healthy controls). RESULTS: The selected researches highlighted the involvement of limbic system, the role of hippocampus and the impact of brain lesions on the emotional status of MS patients. DISCUSSION: In the genesis of depression are implicated many mechanisms including genetic, biochemical, immunological and psychosocial factors, even if a prominent role in the onset of DS seem to be associated with structural and functional brain alterations.

Obstructive sleep apnoea syndrome and endothelial function: potential impact of different treatment strategies-meta-analysis of prospective studies.

PURPOSE: Previous studies have shown an association between obstructive sleep apnoea syndrome (OSAS) and cardiovascular events. Whether this association is mediated by an impairment of endothelial function, which is itself a driver of elevated cardiovascular risk, has yet to be clarified, as it is the eventual protective role of several OSAS treatments. The aim of our meta-analysis is to evaluate the effect of various OSAS treatments on endothelial function calculated by means of flow-mediated dilatation (FMD). METHODS: We conducted a meta-analysis of prospective studies including patients affected by mild to severe OSAS treated with continuous positive airway pressure (CPAP), surgery, oral appliance and medical treatments. FMD was measured before and after treatment RESULTS: After pooling results from different treatment strategies, OSAS treatment showed a positive impact on endothelial function (Mean Difference [MD] = 2.58; 95% CI 1.95-3.20; p < 0.00001). CONCLUSIONS: Our study supports the hypothesis that several modalities of treatment for OSAS positively impact endothelial function. Whether this effect also associates with an improvement of clinical outcomes remains to be ascertained.

A Patient With Toxoplasmosis as a Cause of Submental Lymphadenopathy.

Submental mass secondary to toxoplasmosis is a rare condition and physicians rarely consider its diagnosis. The presented case reports a 43-year-old woman referred with a constant, painless, edema located in the submental area for 2 weeks. Diagnosis of toxoplasmosis was established by the positive serological finding after an accurate medical history of the infectious disease specialist (the patient had eaten raw meat). The patient underwent antimicrobial therapy with resolution of lymphadenopathy. According to review of literature, the article aims to remind clinicians, maxillofacial surgeons, and otolaryngologists that a neck mass can be related to the infectious cause with involving of lymph node like as toxoplasmosis. Therefore, a serological diagnosis should be considered before moving to needle biopsy or excisional biopsy of neck mass.

Cerebrospinal Fluid Leak Following Nasal Packing for Epistaxis.

Anterior epistaxis is commonly treated with Merocel nasal packing insertion. A 63-year-old male patient showed a cerebrospinal fluid rhinorrhea and pneumocephalus immediately after insertion of a Merocel tampon used for spontaneous right anterior epistaxis. He later developed fever and headache. This clinical report is to highlight how the nasal merocel should be positioned by specialized personnel and to describe how to manage this type of complication.

Auditory System Involvement in Psoriasis.

Psoriasis is a systemic inflammatory disorder associated with many other chronic and progressive diseases. There are few studies on the association of psoriasis with alterations in auditory function. A clinical and instrumental pilot study of auditory function was performed with 77 psoriatic patients and 77 age- and sex-matched healthy controls. The main results were: (i) hearing loss, mostly of sensorineural type, was significantly more frequent in patients than in controls; (ii) conductive and mixed hearing loss were more frequent in arthropathic than in non-arthropathic psoriatic patients; (iii) duration of psoriasis > 10 years or smoking were associated with higher frequency of hearing loss; (iv) psoriasis was more severe in patients with hearing loss than in those without hearing loss. Tympanogram abnormalities were found in patients more often than in controls. These data expand the list of extracutaneous conditions associated with psoriasis, and support the need for further basic and clinical research in this field.

Therapeutic efficacy of the Galletti-Contrino manoeuvre for benign paroxysmal positional vertigo of vertical semicircular canals in overweight subjects.

OBJECTIVE: To compare the Galletti-Contrino manoeuvre with the more widely used Semont-Toupet in overweight subjects presenting with benign paroxysmal positional vertigo (BPBV) of vertical semicircular canals (posterior and anterior canals). STUDY DESIGN: Prospective cohort study. PATIENTS: 204 patients (BMI range 25-30) with a diagnosis of BPPV of vertical semicircular canals were randomly divided in two groups treated with two different maneuvers: Galletti-Contrino (Group A) and Semont-Toupet manoeuvre (Group B). The results were compared with those obtained from a control group (204 non-overweight subjects with BPV of vertical semicircular canals.) INTERVENTION: Galletti Contrino/ Semont Toupet manoeuvres. MAIN OUTCOME MEASURE(S): Liberatory nystagmus or vertigo after maximum 2 maneuvers. Vertigo and dizziness intensity scores (Visual analogue scale VAS 0-10) from day 0 to day 5 following the repositioning manoeuvre were also recorded in responsive patients. RESULTS: While in non-overweight subjects no significant difference comparing the effectiveness of the two manoeuvres was found, liberatory nystagmus and vertigo were more frequently observed after Galletti Contrino manoeuvre in overweight subjects; this difference was statistically significant when posterior canals were involved (P < 0.03). Vertigo and dizziness VAS scores reduced significantly from day 0 to day 5 after therapy in all groups. A more significant reduction of dizziness VAS was recorded in patients undergoing Galletti-Contrino manoeuvre at days 4-5 (P < 0.005). CONCLUSION: Galletti-Contrino manoeuvre seems to be significantly more effective than Semont-Toupet manoeuvre in the treatment of BPPV of posterior semicircular canal and may be preferential in patients with limited body movements.

A Multicenter Clinical Evaluation of Data Logging in Cochlear Implant Recipients Using Automated Scene Classification Technologies.

Currently, there are no studies assessing everyday use of cochlear implant (CI) processors by recipients by means of objective tools. The Nucleus 6 sound processor features a data logging system capable of real-time recording of CI use in different acoustic environments and under various categories of loudness levels. In this study, we report data logged for the different scenes and different loudness levels of 1,366 CI patients, as recorded by SCAN. Monitoring device use in cochlear implant recipients of all ages provides important information about the listening conditions encountered in recipients' daily lives that may support counseling and assist in the further management of their device settings. The findings for this large cohort of active CI users confirm differences between age groups concerning device use and exposure to various noise environments, especially between the youngest and oldest age groups, while similar levels of loudness were observed.

Neonatal stridor and laryngeal cyst: Which comes first?

Neonatal stridor is a rare condition usually caused by laryngomalacia. Congenital laryngeal cyst represents an uncommon cause of stridor in the neonatal population and may be misinterpreted as laryngomalacia, leading to serious morbidity and mortality if diagnosis and treatment are delayed. Herein we report the case of a full-term infant with stridor, feeding problems and failure to thrive. Initially, direct laryngoscopy diagnosed only laryngomalacia. As stridor worsened, however, and respiratory distress appeared, repeat laryngoscopy showed vallecular laryngeal cyst, visible macroscopically. The patient was successfully treated with endoscopic marsupialization. There was no evidence of recurrence at follow up after 3 months. This case highlights the importance of laryngoscopic assessment for suspected laryngeal abnormalities in infants with stridor. If symptoms worsen, endoscopy should be repeated, because congenital laryngeal cysts may not be immediately visible macroscopically.

Role of diffusion tensor imaging in the diagnosis and management of post-traumatic anosmia.

INTRODUCTION: Anosmia is a possible complication of Traumatic Brain Injury (TBI). Psychometric and electrophysiological methods of olfaction measure and Magnetic Resonance Imaging (MRI) are the tools to evaluate the post-traumatic olfactory loss. Diffusion Tensor Imaging (DTI) provides useful data for a better understanding of etiopathogenesis TBI-related anosmia, in particular the loss of neural connections and their eventual recovery over time. MATERIALS AND METHODS: This study describes a case of TBI-related anosmia. The olfactory function was evaluated by Sniffin' Sticks Test (SST), Olfactory Event-Related Potentials (OERPs), MRI and DTI at baseline (T0) and after one year (T1). RESULTS: At baseline, SST highlighted a functional anosmia. The OERPs showed the presence of a small N1-P2 complex. MRI confirmed the presence of a scarring involved in the right orbitofrontal cortex (OFC). DTI detected a reduction in the average length and the number of neuronal fibre pathways of right OFC. At T1, a recovery of olfactory function was confirmed by SST and OERPs. CONCLUSION: While MRI images are unchanged from T0, DTI showed an increase in average length and number of fibre tracts in the right OFC. DTI could be a valid tool to display a post-traumatic loss of neural connections and to better understand TBI-recovery mechanisms.

Prevalence of Deafness-Associated Connexin-26 (GJB2) and Connexin-30 (GJB6) Pathogenic Alleles in a Large Patient Cohort from Eastern Sicily.

Mutations in the gene encoding the gap junction protein connexin 26 (GJB2) and connexin 30 (GJB6) have been shown to be a major contributor to prelingual, sensorineural, nonsyndromic deafness. The aim of this study was to characterize and establish the prevalence of GJB2 and GJB6 gene alterations in 196 patients affected by sensorineural, nonsyndromic hearing loss, from Eastern Sicily. We performed sequence analysis of GJB2 and identified sequence variants in 68 out of 196 patients (34.7%); (28 homozygous for c.35delG, 22 compound heterozygous and 11 with only one variant allele). We found 12 different allelic variants, the most prevalent being c.35delG, which was found on 89 chromosomes (65.5%), followed by other alleles with different frequencies (p.E47X, c.-23+1G>A, p.L90P, p.R184W, p.M34T, c.167delT, p.R127H, p.M163V, p.V153I, p.W24X, and p.T8M). Importantly, for the first time we present the frequency and spectrum of GJB2 mutations in NSHL patients from Eastern Sicily. No alterations were found in the GJB6 gene, confirming that alterations in this gene are uncommon in our geographic area. Note that 65.3% and 23.5% of our patients, respectively were found to be negative or carriers by GJB2 molecular screening. This emphasizes the need to broaden the genetic analysis to other genes involved in hearing loss.

Clinical pharmacology of melatonin in the treatment of tinnitus: a review.

PURPOSE: We performed a review with the purpose to summarise, analyse and discuss the evidence provided by clinical studies evaluating effectiveness of melatonin in the cure of tinnitus. Due to the fact that there is no satisfactory treatment for tinnitus, clinical research has explored new therapeutic approaches. METHODS: A search of Pubmed, Medline, Embase, Central and Google Scholar was conducted to find trials published prior March 2014 on melatonin in the treatment of tinnitus. Design of the studies, randomization, allocation concealment procedures and diagnostic instruments (scales for tinnitus evaluation) were critical evaluated. RESULTS: Five clinical studies have been included. Three of them tested effectiveness of melatonin alone, the remaining two along with sulpiride and sulodexide respectively. Considered clinical trials adopted various experimental designs: single arm, randomised placebo-controlled and randomised placebo-controlled followed by crossover. These studies were characterised by several methodological weaknesses. CONCLUSION: Confirmation of melatonin clinical effectiveness in the treatment of tinnitus cannot be given in the light of the biases observed in the considered evidence. Melatonin seems to improve sleep disturbance linked to tinnitus.

Oral gabapentin and intradermal injection of lidocaine: is there any role in the treatment of moderate/severe tinnitus?

The objective of our work is to evaluate recovery induced by gabapentin alone and in association with intradermal infiltration of lidocaine in patients affected by moderate/severe tinnitus. Seventy-two patients suffering from moderate/severe unilateral non-pulsatile subjective tinnitus were enrolled. Severity and behaviour of tinnitus were assessed by Tinnitus handicap Index (THI) on the 8th, 22nd and 36th days from onset of therapy, and on the 3rd and 6th month after the end of therapy in patients treated with oral gabapentin (Group I), oral gabapentin and intradermal injection of lidocaine (Group II), and placebo (Group III) Significant differences in THI scores from the 8th day of therapy to the 22nd (p < 0.0001) and from the 22nd day to the 36th (p = 0.0002 and p = 0.0004, respectively) were found in Group I and Group II. In Group II, another relevant decrease of THI scores from the 36th day of therapy to 3 months from the end of treatment (p = 0.0004) was found. A significant difference in THI scores between Group I and Group II was found after 8 days of treatment (p = 0.05) with a more relevant decrease registered in Group II; significant differences were also found in THI scores between Group I and Group III after 8 days of treatment (p = 0.01), with a more relevant decrease registered in Group III; significant differences in THI scores between Group II and Group III were found after 36 days of treatment (p = 0.009), 3 and 6 months after the end of therapy (p = 0.005 and p = 0.007, respectively), with a more relevant decrease registered in Group II. In conclusion, the use of gabapentin associated to lidocaine seems to be superior to placebo and gabapentin in relieving tinnitus.