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IntroductionMenière’s disease (MD) is a multifactorial disease characterised by recurring vertigo, tinnitus and fluctuating sensorineural hearing loss as typical clinical symptoms. For patients with MD with poor response to non-invasive treatments, it is recommended to use intratympanic gentamicin treatment. The destruction of vestibular organs by gentamicin may cause residual vestibular symptoms, notably unsteadiness. However, most previous clinical studies paid little attention to this issue. Currently, vestibular rehabilitation treatment (VRT) has been proven to be an effective method for controlling vestibular symptoms and has been applied to patients with various vestibular diseases. The aim of this study is to investigate the efficacy of VRT versus usual care in MD patients who experience persistent unsteadiness for 1 month after intratympanic gentamicin treatment, in order to understand whether VRT has a positive impact on balance maintenance and vertigo control in patients with MD.Methods and analysisRandomised, assessor-blinded, controlled clinical trials will be used to compare the efficacy of balance function before and after VRT. Patients with MD who experience chronic unsteadiness for 1 month after intratympanic gentamicin treatment will be recruited and receive VRT, mainly including gaze stability training, gait rehabilitation, vestibular habituation training, etc. The outcomes assessments will be conducted at baseline and at eighth week and sixth month post-randomisation. The primary outcome will be the improvements in vestibular function quantified through the Functional Gait Assessment. The secondary outcomes will include sensory organisation test, vestibular laboratory tests (video head impulse test, caloric test and vestibular evoked myogenic potentials), Menière’s disease outcomes questionnaire, visual vertigo analogue scale and vestibular activities and participation measure.Ethics and disseminationThis trial received ethical approval from the Institutional Review Board of Eye and ENT Hospital of Fudan University (reference number 2024020). The study results will be disseminated via peer-reviewed journals and conferences.Trial registration number NCT06143462.

IntroductionBenign paroxysmal positional vertigo (BPPV) is recognised as the leading cause of peripheral vertigo in adults. The canalith repositioning procedure (CRP) can be used for effective treatment of BPPV. However, some patients experience residual dizziness (RD) even after successful CRP, resulting in a significant negative impact on their daily function and quality of life. Exercise-based vestibular rehabilitation (VR) has been proven as an effective method for managing dizziness and has been applied in patients with various vestibular disorders. However, the efficacy of VR to specifically target RD post-BPPV is unknown. This study aims to investigate the efficacy of VR, compared with betahistine or VR plus betahistine treatment, in the treatment of patients experiencing RD after successful CRP.Methods and analysisA randomised single-blinded controlled trial will be carried out to determine the efficacy of VR compared with betahistine or VR plus betahistine treatment in mitigating RD and improving balance function. Patients with BPPV who experience RD after successful CRP will be recruited. Participants will be randomised into one of three groups to receive VR, betahistine or VR plus betahistine. There will be 61 participants in each group. The primary outcomes will be changes in the patient’s daily function as measured by the Vestibular Activities and Participation questionnaire and balance ability assessed by computerised dynamic posturography. The secondary outcomes will be dizziness-related handicap, otolith function and duration of RD symptoms. Outcome measures will be noted at baseline and at 2, 4 and 8 weeks post-randomisation. This study has the potential to reduce unnecessary anti-vertigo drug prescriptions and may lead to a general consensus regarding the use of VR as a first-line treatment for RD in patients with BPPV.Ethics and disseminationThis trial received ethical approval from the Institutional Review Board of Eye and ENT Hospital of Fudan University (reference number 2017046). The study results will be disseminated via peer-reviewed journals and conferences.Trial registration number NCT03624283; Pre-results.

Questionnaires have been used in the past 2 decades to predict the diagnosis of vertigo and assist clinical decision-making. A questionnaire-based machine learning model is expected to improve the efficiency of diagnosis of vestibular disorders. This study aims to develop and validate a questionnaire-based machine learning model that predicts the diagnosis of vertigo. In this multicenter prospective study, patients presenting with vertigo entered a consecutive cohort at their first visit to the ENT and vertigo clinics of 7 tertiary referral centers from August 2019 to March 2021, with a follow-up period of 2 months. All participants completed a diagnostic questionnaire after eligibility screening. Patients who received only 1 final diagnosis by their treating specialists for their primary complaint were included in model development and validation. The data of patients enrolled before February 1, 2021 were used for modeling and cross-validation, while patients enrolled afterward entered external validation. A total of 1693 patients were enrolled, with a response rate of 96.2% (1693/1760). The median age was 51 (IQR 38-61) years, with 991 (58.5%) females; 1041 (61.5%) patients received the final diagnosis during the study period. Among them, 928 (54.8%) patients were included in model development and validation, and 113 (6.7%) patients who enrolled later were used as a test set for external validation. They were classified into 5 diagnostic categories. We compared 9 candidate machine learning methods, and the recalibrated model of light gradient boosting machine achieved the best performance, with an area under the curve of 0.937 (95% CI 0.917-0.962) in cross-validation and 0.954 (95% CI 0.944-0.967) in external validation. The questionnaire-based light gradient boosting machine was able to predict common vestibular disorders and assist decision-making in ENT and vertigo clinics. Further studies with a larger sample size and the participation of neurologists will help assess the generalization and robustness of this machine learning method.

Background Otitis media with effusion (OME) is a common disease in ear, nose, and throat clinics characterized by aural fullness and hearing loss and mainly caused by eustachian tube dysfunction (ETD). Tympanostomy tube insertion (TTI) is a conventional surgical treatment option that can alleviate symptoms but does not provide a definitive cure, and it is prone to recurrence. Balloon dilation eustachian tuboplasty (BDET) has become a novel procedure for the treatment of ETD, demonstrating significant potential in addressing the aforementioned limitations. However, it is not widely available in the clinic and few high-quality randomized clinical trials was conducted to investigate its long-term efficacy and security in OME. Therefore, the purpose of this study is to verify the efficacy of BDET combined with TTI for patients with OME and its prospects for providing a definitive cure. Methods and analysis This is a prospective, parallel-group, single-blind, randomized controlled prospective trial. Totally 124 patients with OME will be randomized into either group A or B. Group A will receive conventional therapy (TTI) while group B will use BDET therapy in addition to TTI. Outcome assessments will take place at baseline and at the 3rd, 6th, 12th, and 24th months after surgery. The primary outcome is eustachian tube function, which will be measured by the eustachian tube dysfunction questionnaire (ETDQ-7) and eustachian tube score (ETS). The secondary outcomes include middle ear function, hearing situation, and quality of life, which will be measured by acoustic impedance measurement, pure-tone audiometry, and Chinese-version Chronic Ear Survey (CCES). The main analysis of change in the outcomes will use mixed-model with repeated measures (MMRM) analyses of variance (ANOVAs). Discussion This is the first prospective trial in Chinese populations that aims to validate the long-term efficacy and safety of BDET-combined TTI therapy in patients with OME. This parallel-group, single-blind, randomized controlled trial may provide an opportunity to decrease the recurrence rate of OME and explore a definitive cure for patients with OME. This trial’s rigorous design enhances the reliability of the findings, ensuring a robust answer to the research question. In the future, the research team will further expand upon the clinical evidence and applications of the BDET combined therapy. Trial registration Chinese Clinical Trial Registry ChiCTR2400079632. Registered on 8 January 2024, https://www.chictr.org.cn/bin/project/edit?pid=214452 .

Purpose Laryngeal tumors can cause significant anatomical distortion, making tracheal intubation challenging. Compared to video laryngoscope (VL), intubation using a Disposcope endoscope (DE) offers flexibility and allows for better navigation around obstructive lesions in the upper airway. This study aimed to compare the clinical performance of DE and VL for anticipated laryngeal tumor related difficult intubation in Ear, Nose, and Throat (ENT) patients undergoing general anesthesia. Methods We conducted a prospective, randomized, controlled trial. Eighty patients with anticipated difficult intubation due to laryngeal tumors undergoing elective surgery were included and randomly allocated to either the DE group ( n  = 40) or the VL group ( n  = 40). The primary outcome was the first-attempt success rate of tracheal intubation. Secondary outcomes included intubation time, hemodynamic response, and the incidence of complications related to intubation. Results A total of 80 subjects (61 male/19 female, 30 to 81 years old) were included in the final analysis. The first-attempt success rate of tracheal intubation was significantly higher in the DE group compared with the VL group (97.5% vs. 77.5%; mean difference [95% CI]: 20% [5.5 to 35.1]; P  = 0.007). The intubation time was reduced in the DE group compared to the VL group (28.5 ± 6.7 s vs. 39.0 ± 10.0 s, mean difference [95% CI]: 10.5 s [6.7 to 14.3]; P  < 0.001). Compared to DE, VL exhibited a higher heart rate one minute after intubation (71.1 ± 10.9 bpm vs. 78.3 ± 12.8 bpm; mean difference [95% CI]: 7.2 bpm [1.9 to 12.5]; P  = 0.008). The incidence of postoperative airway complications was not significantly different between the two groups. Conclusion The DE showed a higher first-attempt success rate and a shorter intubation time than the VL for anticipated laryngeal tumor related difficult intubation in ENT patients undergoing general anesthesia. Trial registration Chinese Clinical Trials Identifier ChiCTR2300068449.

IntroductionDizziness is one of the most common symptoms seen in chronic vestibular syndrome, which has been linked to an increased risk of falls, substantial disability and negative psychological consequences. Recent evidence demonstrated that vestibular rehabilitation therapy (VRT) is effective for treating chronic vestibular symptoms. However, the delivery of VRT remains challenging because of lack of facility, insufficient qualified physiotherapist resources, as well as being in the actual situation of the pandemic. WeChat, the most widely used mobile app in China, offers a more viable way of delivering VRT than traditional office-based approaches do. This study aimed to evaluate the effectiveness of the WeChat-VRT programme for patients with chronic vestibular syndrome.Methods and analysisThis is a parallel-group, assessor-blinded randomised controlled trial. Fifty patients who experienced chronic vestibular symptoms longer than 3 months will be randomised into either the WeChat-VRT group or the usual care (UC) group. Participants in the WeChat-VRT group will receive 8-week VRT mainly through the WeChat app. Participants in the UC group will receive once-weekly VRT in the clinic for 8 weeks and remaining time home-based exercise. Outcome assessments will take place at baseline and at the 8th, 12th and 24th weeks after randomisation. The primary outcome will be the change from baseline to the eighth week on the patients’ functional improvements quantified by the Functional Gait Assessment (FGA). The secondary outcomes will include dynamic balance function, emotional well-being, and vestibular activity and participation level. Intention-to-treat analysis will be performed using generalised estimation equation modelling.Ethics and disseminationThe trial has been reviewed and approved by the Institutional Review Board of Eye and Ear Nose Throat Hospital of Fudan University (reference number 2017047/1). The study findings will be disseminated via peer-reviewed journals and conferences.Trial registration numberChiCTR2000029457; Pre-results.

Background Benign Paroxysmal Positional Vertigo (BPPV) is the leading cause of vertigo, and its characteristic nystagmus induced by positional maneuvers makes it a good model for Artificial Intelligence (AI) diagnosis. However, during the testing procedure, up to 10 min of indivisible long-range temporal correlation data are produced, making the AI-informed real-time diagnosing unlikely in clinical practice. Methods A combined 1D and Deep-Learning (DL) composite model was proposed. Two separate cohorts were recruited, with one for model generation and the other for evaluation of model’s real-world generalizability. Eight features, including two head traces and three eye traces and their corresponding slow phase velocity (SPV) value, were served as the inputs. Three candidate models were tested, and a sensitivity study was conducted to determine the saliently important features. Results The study included 2671 patients in the training cohort and 703 in the test cohort. A hybrid DL model achieved a micro-area under the receiver operating curve (AUROC) of 0.982 (95% CI 0.965, 0.994) and macro-AUROC of 0.965 (95% CI 0.898, 0.999) for overall classification. The highest accuracy was observed for right posterior BPPV, with an AUROC of 0.991 (95% CI 0.972, 1.000), followed by left posterior BPPV, with an AUROC of 0.979 (95% CI 0.940, 0.998), the lowest AUROC was 0.928 (95% CI 0.878, 0.966) for lateral BPPV. The SPV was consistently identified as the most predictive feature in the models. If the model process is carried out 100 times for a 10-min data, one single running takes 0.79 ± 0.06 s. Conclusion This study designed DL models which can accurately detect and categorize the subtype of BPPV, enabling a quick and straightforward diagnosis of BPPV in clinical setting. The critical feature identified in the model helps expand our understanding of this disorder.

Purpose To assess vision-related quality of life (VRQoL) in Chinese glaucoma patients and explore its sociodemographic, clinical and psychological correlates, and determine which of them explain the largest variation. Methods This cross-sectional study included 508 Chinese glaucoma patients. Chinese-version Glaucoma Quality of Life-15 questionnaire (CHI-GQL-15) and Hospital Anxiety and Depression Scales were administered to all participants to evaluate their VRQoL and psychological distresses. Visual functions (habitual-corrected visual acuity (HCVA), intraocular pressure, and mean defect (MD) of visual field) were assessed through clinical examinations by professionals. Sociodemographic information and other treatment histories were collected via interviews and chart review. Stepwise multiple linear regression analyses were performed to identify sociodemographic, clinical, and psychological predictors of VRQoL. Results The mean summary score for CHI-GQL-15 was 28.79 ± 12.74. Patients exhibited the greatest difficulty in activities involving glare and dark adaptation (28.19 ± 22.86), followed by central and near vision (26.18 ± 26.56), peripheral vision (18.03 ± 21.37), and the least difficulty for outdoor mobility (15.06 ± 24.57). Moderate and heavy economic burden, HCVA and MD of both the better and the worse eyes, number of glaucoma surgeries in the treatment history and the presence of depression were independent predictors for VRQoL of glaucoma patients. Clinical factors explained the largest variation. Conclusion VRQoL of glaucoma patients is multifactorial and was primarily determined by clinical indices. VRQoL assessment could be informative when adopted as a complement to objective visual measures in clinical practice.

Introduction Total laryngectomy (TL) with neck dissection (ND) is considered as crucial management for advanced-stage of laryngeal cancer. Shoulder dysfunction has long been recognized as a potential complication resulting from neck dissection. The aim of this study was to evaluate the effect of early prophylactic rehabilitation program in patients who underwent TL with ND. Methods A prospective, nonrandomized design was used. Seventy-six participants who underwent TL with ND were assigned into either an intervention or a control group. The control group received current standard care with no formal shoulder exercise provided, while the intervention group attended early preventive rehabilitation lasting 12 weeks. Participants were assessed at baseline, and at 3 and 6 months after surgery. Measured outcomes included shoulder function and patient-reported quality of life. General linear models with repeated measures were used to examine outcome changes in both groups over the designated assessment intervals. Results Improvement in shoulder function and patient-reported quality of life were both statistically significant over time, with no significant difference between control or intervention groups, indicating little or no benefit of preventative intervention on shoulder function outcomes. Analysis involving five subscales and the summary score of the quality of life questionnaire had only statistically significant improvement over time for both the control or intervention groups, except for physical well-being domain which had statistical significance both over time and between the control and intervention groups. Conclusion In this study, preventative exercise program initiated immediately after surgery had a limited impact on both shoulder function and perceived quality of life.

Background Maintaining glaucoma patients’ quality of life (QoL) has become one of the most important goals for treatments. The purpose of this study is to develop a Chinese version of Glaucoma Quality of Life-15 item Questionnaire (GQL-15-CHI), and examine its psychometric properties. Methods The Glaucoma Quality of Life-15 item Questionnaire (GQL-15) was translated and culturally adapted into Chinese, and administered to glaucoma patients recruited from Shanghai Eye and ENT Hospital. Visual functions: habitual-corrected visual acuity (HCVA), intraocular pressure (IOP), and mean defect (MD) of visual field) were assessed through clinical examination by professionals. Sociodemographic and other clinical data were collected via interviews and chart review. According to Nelson’s glaucoma staging system, patients were stratified as mild, moderate, and severe visual field loss (VFL). The psychometric properties, including internal consistency, test-retest reliability, item-scale correlations and factor analysis were conducted. The divergent validity was assessed through bilateral comparisons of the GQL-15-CHI composite and subscale scores between patients of different VFLs after controlling for potential confounders. Results A total of 508 glaucoma patients were recruited (male: 265, female: 243). The mean age was 55.41 years. The Cronbach’s α coefficients ranged from 0.75 to 0.91 for the subscales. The test-retest reliability, as estimated by the intraclass correlation coefficients, were above 0.70 for all subscales. Statistically significant differences were showed in the GQL-15-CHI summary and subscale scores after controlling for sociodemographic and clinical confounders (P < 0.05) among patients with different VFLs. Conclusion The GQL-15-CHI showed psychometric properties comparable to those of the original English version, and thus could be used as a reliable and valid tool for assessment of QoL in Chinese glaucoma patients.