Polysomnographic airflow shapes and site of collapse during drug-induced sleep endoscopy.

RATIONALE: Differences in the pharyngeal site-of-collapse influences efficacy of non-CPAP therapies for obstructive sleep apnoea (OSA). Notably, complete concentric collapse at the palate (CCCp) during drug-induced sleep endoscopy (DISE) is associated with reduced efficacy of hypoglossal nerve stimulation, but CCCp is currently not recognisable using polysomnography. Here we develop a means to estimate DISE-based site-of-collapse using overnight polysomnography. METHODS: 182 OSA patients provided DISE and polysomnography data. Six polysomnographic flow-shape characteristics (mean during hypopnoeas) were identified as candidate predictors of CCCp (primary outcome variable, N=44/182), including inspiratory skewness and inspiratory scoopiness. Multivariable logistic regression combined the six characteristics to predict clear presence (N=22) versus absence (N=128) of CCCp (partial collapse and concurrent tongue-base collapse excluded). Odds ratios for actual CCCp between predicted subgroups were quantified after cross-validation. Secondary analyses examined complete lateral wall, tongue-base, or epiglottis collapse. External validation was performed on a separate dataset (Ntotal=466). RESULTS: CCCp was characterised by greater scoopiness (ß=1.5±0.6 per 2SD, multivariable estimate±se) and skewness (ß=11.4±2.4) compared to non-CCCp. Odds ratio [95%CI] for CCCp in predicted positive versus negative subgroups was 5.0[1.9-13.1]. The same characteristics provided significant cross-validated prediction of lateral wall (OR=6.3[2.4-16.5]), tongue-base (3.2[1.4-7.3]), and epiglottis (4.4[1.5-12.4]) collapse. CCCp and lateral wall collapse shared similar characteristics (skewed, scoopy), diametrically opposed to tongue-base and epiglottis collapse characteristics. External validation confirmed model prediction. CONCLUSIONS: The current study provides a means to recognise patients with likely CCCp or other DISE-based site-of-collapse categories using routine polysomnography. Since site-of-collapse influences therapeutic responses, polysomnographic airflow shape analysis could facilitate precision site-specific OSA interventions.

Comparative analysis of two custom-made mandibular advancement devices with varied designs for treating moderate to severe obstructive sleep apnea.

INTRODUCTION: Custom-made titratable mandibular advancement device (MAD) treatment can nowadays be considered a promising first-line treatment in patients with mild to severe obstructive sleep apnea (OSA). Specific manufacturing designs and titration mechanisms of MAD are on the market, characterized by their titration approach, vertical opening, and materials selection. The wing-designed MAD (SomnoDent® Flex™, SomnoMed Ltd, Sydney, Australia) has a lateral screw mechanism to advance the lower jaw in incremental steps of 0.1 up to 6.0 mm. The newer uniquely designed custom-made MAD with passive mouth closing (SomnoDent® Avant™ SomnoMed Ltd, Sydney, Australia) has a frontal exchangeable advancement strap of fixed lengths as a specific titration mechanism, all supporting freedom of lateral movement. We aimed to assess the associations between the type of MAD prescribed and OSA treatment outcome. METHODS: Data from 209 patients (165 male, mean age 53.9 (±10.9) years, median baseline BMI and AHI 27.02 [24.8; 29.7] kg/m2 and 22.8 [17.7; 31.6]/hour sleep, respectively) were collected. Of this cohort, 91 patients with the traditional, wing-based SomnoDent® Flex™ and 118 patients with SomnoDent® Avant™. All patients were diagnosed with a type 1 polysomnography demonstrating moderate to severe OSA (15 ≤ AHI ≤65 per hour sleep). The selected MAD was fitted in the so-called maximal comfortable protrusion. After 3 months of subjective titration until resolution of subjective symptoms and/or achieving physical limits, a checkup with validated home sleep monitoring was conducted. Treatment success was defined as "AHI reduction ≥50% with MAD compared to baseline AHI and AHI with MAD <10 events per hour". RESULTS: These real-world data set showed that 67% of patients achieved treatment success, with a statistically significant reduction in AHI from 22.8 [17.7; 31.6] to 7.45 [3.4; 15.0]/h sleep. The SomnoDent® Avant™ achieved 75% treatment success versus 56% for the traditional, wing-based SomnoDent® Flex™ (P < 0.05). Overall, AHI reduction was 70% for SomnoDent® Avant™ (P < 0.05) vs. 63% for SomnoDent® Flex™ (P < 0.05). CONCLUSIONS: This study shows that choice of MAD design can impact the treatment outcome and could become an important consideration in selecting the type of MAD for personalized treatment for OSA patients. While the results of the traditional wing-based MAD design were comparable to the therapeutic outcome with other titratable, custom-made MADs, the MAD with the passive mouth closing feature showed significantly greater reduction in total AHI potentially due to encouraged nasal breathing, reduced mouth breathing and lesser vertical opening thereby decreasing the probability of tongue base collapse.

Tinnitus suppression by means of cochlear implantation: does it affect cognition?

PURPOSE: Recent literature suggests that tinnitus can impact cognition, but results were varied due to a diversity in investigated aspects of cognition and utilized tests, as well as the possible influence of confounding factors. The purpose of this study was to assess the impact of tinnitus loudness on cognition by use of a within-subjects design in patients with a cochlear implant (CI). In this population, tinnitus loudness can be modulated by switching the CI on or off as CI is known to highly suppress tinnitus. METHODS: A total of 18 CI users completed two versions of the Repeatable Battery for Assessment of Neuropsychological Status for Hearing Impaired individuals (RBANS-H), once in unaided condition and once in best aided condition. Tinnitus suppression was defined as a difference in score on a visual-analogue scale (VAS) of at least one point out of ten between these two conditions. RESULTS: No significant differences in RBANS-H scores were found between the suppression and no suppression group, nor for the suppression group alone. No significant correlations between tinnitus loudness and RBANS-H were found, neither for the suppression group alone, nor for the group as a whole. CONCLUSION: The current study shows no significant effect of tinnitus loudness on cognition, which contradicts previous literature. This discrepancy could be explained by the use of a within-subjects design, which controls for confounding factors. Future research should include a larger and more diverse study sample to draw definitive conclusions on this topic.

How can peer teaching influence the development of medical students? a descriptive, longitudinal interview study.

BACKGROUND: Peer-assisted learning (PAL) - where students take up a teaching role at an early stage of their training-is widely used in medical curricula. Many qualitative studies have investigated the perceptions and benefits of PAL, but no studies have longitudinally explored how peer teachers experienced their development. This could allow for a better understanding of PAL. In this study, we explored the perceived impact of being a peer teacher on the development of personal and professional competencies as a medical student. METHODS: We longitudinally conducted semi-structured interviews with peer teachers, during their 2-year teaching period in the skills lab at the University of Antwerp and applied descriptive thematic analysis. RESULTS: In total we gathered 47 interviews in 13 peer teachers (9 female, 4 male,. 1-7 interviews each). Peer teachers reported an increase in self-confidence, which gradually transformed into self-efficacy in clinical and teaching skills., Participants told us to be inspired by the previous generation of peer teachers. Their motivation shifted from personal benefits to benefiting others while becoming a role model themselves. The peer teachers illustrated how they developed maturity by integrating different CanMEDS roles. They grew in reflection, changed/transformed an initial mark-driven study drive into more patient-centered ambitions, and started developing a personal style. CONCLUSIONS: Our study suggests that being a peer teacher leads to more self-efficacy, in clinical and teaching skills, to become a role model with as motivation to benefit others and to grow towards a good doctor maturity. Although the task is to teach peers, this opportunity nurtures the practice and integration of various CanMEDS roles, not only that of scholar but also communicator, collaborator and leader, thereby positively influencing their personal and professional development and their identity as a doctor (professional role).

Listening effort and fatigue among cochlear implant users: a scoping review.

Introduction: In challenging listening situations, speech perception with a cochlear implant (CI) remains demanding and requires high levels of listening effort, which can lead to increased levels of listening-related fatigue. The body of literature on these topics increases as the number of CI users rises. This scoping review aims to provide an overview of the existing literature on listening effort, fatigue, and listening-related fatigue among CI users and the measurement techniques to evaluate them. Methods: The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) Statements were used to conduct the scoping review. The search was performed on PubMed, Scopus, and Web of Science to identify all relevant studies. Results: In total, 24 studies were included and suggests that CI users experience higher levels of listening effort when compared to normal hearing controls using scales, questionnaires and electroencephalogram measurements. However, executing dual-task paradigms did not reveal any difference in listening effort between both groups. Uncertainty exists regarding the difference in listening effort between unilateral, bilateral, and bimodal CI users with bilateral hearing loss due to ambiguous results. Only five studies were eligible for the research on fatigue and listening-related fatigue. Additionally, studies using objective measurement methods were lacking. Discussion: This scoping review highlights the necessity for additional research on these topics. Moreover, there is a need for guidelines on how listening effort, fatigue, and listening-related fatigue should be measured to allow for study results that are comparable and support optimal rehabilitation strategies.

The prevalence of treatment-emergent central sleep apnea with mandibular advancement device therapy.

STUDY OBJECTIVES: Treatment-emergent central sleep apnea (TECSA) describes the appearance or persistence of central sleep apnea while undergoing treatment for obstructive sleep apnea. TECSA is well studied in continuous positive airway pressure therapy with an estimated prevalence of 8%. Based on a few case reports, mandibular advancement devices (MAD) may also provoke TECSA. This study aims to gain insight into the prevalence of TECSA with MAD therapy. METHODS: This retrospective study includes a total of 129 patients with moderate to severe obstructive sleep apnea who were treated with a custom-made titratable MAD. Baseline and follow-up sleep studies were compared to identify patients with TECSA. Since different diagnostic criteria to define TECSA are used in literature, prevalence was calculated according to three definitions (TECSA-1, -2, and -3). Demographics, MAD treatment variables, and findings of the diagnostic polysomnography were compared between TECSA and non-TECSA patients to identify possible predictors. RESULTS: Depending on the definition used, TECSA was found in 3.1%-7.8% of patients undergoing MAD therapy. TECSA patients had a higher apnea index (9.2 vs 2.0 events/h, P = .042), central apnea-hypopnea index (4.1 vs 0.2 events/h, P = .045) and oxygen desaturation index (23.9 vs 16.3 events/h, P = .018) at baseline compared to non-TECSA patients. No differences were found in demographics and treatment variables. CONCLUSIONS: These findings demonstrate that TECSA also occurs in patients starting MAD treatment. Patients with TECSA had a higher apnea index, central apnea-hypopnea index, and oxygen desaturation index at baseline compared to non-TECSA patients. CITATION: Hellemans S, Van de Perck E, Braem MJ, Verbraecken J, Dieltjens M, Vanderveken OM. The prevalence of treatment-emergent central sleep apnea with mandibular advancement device therapy. J Clin Sleep Med. 2023;19(12):2035-2041.

Quantitative Measurement of Pharyngeal Dimensions During Drug-induced Sleep Endoscopy for Oral Appliance Outcome.

OBJECTIVE: To quantitatively investigate the effect of mandibular advancement devices (MADs) on pharyngeal airway dimensions in a transverse plane as measured during drug-induced sleep endoscopy (DISE). METHODS: Data from 56 patients, treated with MAD at 75% maximal protrusion and with baseline Apnea-Hypopnea Index ≥10 events/h, were analyzed. For each patient, three snapshots were selected from DISE video footage at baseline, with MAD presence, and during chin lift, resulting in 498 images (168/168/162, baseline/MAD/chin lift). Cross-sectional areas, anteroposterior (AP) and laterolateral (LL) dimensions on both retroglossal and retro-epiglottic levels were measured. To define the effect of MAD and chin lift on pharyngeal dimensions, linear mixed-effect models were built. Associations between MAD treatment response and pharyngeal expansion (MAD/chin lift) were determined. RESULTS: Significant differences were found between retroglossal cross-sectional areas, AP, and LL dimensions at baseline and with MAD presence. At a retro-epiglottic level, only LL dimensions differed significantly with MAD presence compared to baseline, with significant relation of LL expansion ratio to treatment response (p = 0.0176). After adjusting the response definition for the sleeping position, greater retroglossal expansion ratios were seen in responders (1.32 ± 0.48) compared to non-responders (1.11 ± 0.32) (p = 0.0441). No significant association was found between response and pharyngeal expansion by chin lift. CONCLUSION: Our observations highlight the additional value of quantitative pharyngeal airway measurements during DISE with MAD presence in evaluating MAD treatment outcome. These findings demonstrate an increase in retroglossal airway dimensions during DISE, with MAD presence, and more pronounced increase in retroglossal expansion ratios in MAD treatment responders compared to non-responders after sleeping position correction. LEVEL OF EVIDENCE: 3 Laryngoscope, 133:3619-3627, 2023.

Prevalence of tinnitus and hyperacusis in 9-12-year-old children.

OBJECTIVES: To estimate the prevalence of tinnitus and hyperacusis in children aged 9-12 years in Flanders, as well as to explore the associations with hearing abilities and listening behaviours. DESIGN: A cross-sectional survey was undertaken in four different Flemish schools. The questionnaire was distributed among 415 children, with a response rate of 97.3%. RESULTS: The prevalence of permanent tinnitus was 10.5% and of hyperacusis was 3.3%. The hyperacusis prevalence was higher in girls (p < .05). Some children reported effects of tinnitus in terms of anxiety (20.1%), sleep (36.5%), and concentration (24.8%). When listening to personal listening devices, 33.5% of the children reported to listen for at least 1 h at 60% or higher of the volume range. Moreover, 54.9% of children stated to never wear hearing protection. CONCLUSIONS: Tinnitus and hyperacusis are prevalent in children aged 9-12 years. Some of these children might be overlooked and, as such, not receiving the required follow-up or counselling. Development of guidelines for the assessment of these auditory symptoms in children would help to determine the prevalence numbers with greater accuracy. Sensibility campaigns for safe listening are warranted, as more than half of the children never use hearing protection.

The effect of CPAP on the upper airway and ventilatory flow in patients with obstructive sleep apnea.

BACKGROUND: Continuous positive airway pressure (CPAP) is the mainstay of treatment for obstructive sleep apnea (OSA). However, data about its effect on the upper airway, especially the epiglottis, are scarce. The aim of this study was to investigate the changes in upper airway dimensions and inspiratory flow in response to incremental pressure levels. METHODS: This is a secondary analysis of a prospective clinical trial in which patients with moderate to severe OSA underwent drug-induced sleep endoscopy with simultaneous recordings of flow and mask pressure. CPAP was titrated in small increments. For each pressure level a representative 3-breath segment was selected to determine specific flow features. The corresponding endoscopic footage was reviewed to assess the degree of upper airway collapse in a semi-quantitative manner. RESULTS: A total of 214 breath segments were obtained from 13 participants (median [Q1-Q3]; apnea-hypopnea index, 24.9 [20.1-43.9] events/h; body mass index 28.1 [25.1-31.7] kg/m²). CPAP significantly increased cross-sectional dimensions of the soft palate, lateral walls and tongue base, but not of the epiglottis, and induced epiglottis collapse in one subject. Increased pressure improved peak inspiratory flow and median ventilation in all patients, even in the presence of persistent epiglottis collapse. CONCLUSION: CPAP does not effectively address epiglottis collapse in patients with OSA. However, it normalizes inspiratory flow regardless of its effect on the epiglottis. This clinical trial was registered on January 18th, 2020 on ClinicalTrials.gov with identifier NCT04232410.

Evaluation of Cognitive Functioning Before and After Cochlear Implantation in Adults Aged 55 Years and Older at Risk for Mild Cognitive Impairment.

Importance: Given the rapidly rising dementia incidence, management of modifiable risk factors, such as hearing loss, is vital. Multiple studies have demonstrated an improvement of cognitive functioning in older adults with severe hearing loss after cochlear implantation; however, few of these studies, to the authors' knowledge, specifically analyzed participants achieving poor cognitive results preoperatively. Objective: To evaluate the cognitive functioning of older adults with severe hearing loss at risk for mild cognitive impairment (MCI) before and after cochlear implantation. Design, Setting, and Participants: This prospective, longitudinal cohort study performed at a single center reports data obtained over a 6-year period (April 2015 to September 2021) of an ongoing prospective, longitudinal cohort study on cochlear implant outcomes in older adults. A consecutive sample of older adults with severe hearing loss eligible for cochlear implantation was included. All participants obtained a Repeatable Battery for the Assessment of Neuropsychological Status for hearing-impaired patients (RBANS-H) total score indicative of MCI preoperatively. Participants were assessed before cochlear implant activation and 12 months after cochlear implant activation. Intervention: The intervention consisted of cochlear implantation. Main Outcome and Measure: The primary outcome measure was cognition, measured by the RBANS-H. Results: A total of 21 older adult cochlear implant candidates were included in the analysis (mean [SD] age, 72 [9] years; 13 [62%] men). Cochlear implantation was associated with an improvement of overall cognitive functioning 12 months after activation (median [IQR] percentile, 5 [2-8] vs 12 [7-19]; difference, 7 [95% CI, 2-12]). Eight participants (38%) surpassed the MCI cutoff (16th percentile) postoperatively, while the overall median cognitive score remained under this cutoff. In addition, participants' speech recognition in noise improved, with a lower score indicating improvement (mean [SD] score, +17.16 [5.45] vs +5.67 [6.3]; difference, -11.49 [95% CI, -14.26 to -8.72]), after cochlear implant activation. Improvement of speech recognition in noise was positively associated with improvement in cognitive functioning (rs, -0.48 [95% CI, -0.69 to -0.19]). Years of education, sex, RBANS-H version, and symptoms of depression and anxiety were not related to the evolution in RBANS-H scores. Conclusions and Relevance: In this prospective, longitudinal cohort study, cognitive functioning and speech perception in noise showed a clinically meaningful improvement 12 months after cochlear implant activation in older adults with severe hearing loss at risk for MCI, suggesting that cochlear implantation is not contraindicated in cochlear implant candidates with cognitive decline and should be considered after multidisciplinary evaluation.

Effectiveness of Telerehabilitation Interventions for Self-management of Tinnitus: Systematic Review.

BACKGROUND: Tinnitus is a highly prevalent symptom affecting 10%-20% of the adult population. Most patients with tinnitus have chronic tinnitus, which can directly or indirectly disrupt their daily life and negatively affect the health-related quality of life. Therefore, patients with tinnitus are frequently in need of costly and time-consuming treatments. As an answer, telerehabilitation interventions are on a rise to promote self-management in patients with tinnitus and reduce their dependency on in-person care. OBJECTIVE: This systematic review aimed to provide an overview of the research concerning the effectiveness of telerehabilitation interventions for self-management of tinnitus. METHODS: This systematic review adheres to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. Studies were eligible for inclusion if study participants were adult patients with complaints of primary subjective tinnitus and the study intervention comprised any possible telerehabilitation form for the self-management of tinnitus complaints. A search for eligible studies was conducted on PubMed, ScienceDirect, Scopus, Web of Science, and Cochrane Library. The Cochrane Risk of Bias 2 tool was used to the assess risk of bias. RESULTS: In total, 29 articles were found eligible, and of these, 5 (17%) studied multiple telerehabilitation forms. Internet-based cognitive behavioral treatment with guidance by a psychologist or audiologist was examined in 17 studies (n=1767), internet-based cognitive behavioral treatment without guidance was examined in 4 studies (n=940), self-help manuals were examined in 1 study (n=72), technological self-help devices were examined in 2 studies (n=82), smartphone apps were examined in 8 studies (n=284), and other internet-based interventions were examined in 2 studies (n=130). These rehabilitation categories were proven to be effective in decreasing tinnitus severity and relieving tinnitus distress as measured by tinnitus questionnaires such as Tinnitus Functional Index, Tinnitus Handicap Inventory, or Tinnitus Reactions Questionnaire. However, dropout rates were often high (range 4%-71.4%). All studies reported between some concerns and high concerns of risk of bias, resulting in low to moderate certainty levels. CONCLUSIONS: Overall, there is low to moderate quality evidence that telerehabilitation interventions effectively reduce tinnitus severity and distress. These interventions form a possible tool to improve the self-management capacities of the patient and the accessibility of tinnitus care as a replacement or an addition to in-person care. Nevertheless, barriers such as lack of time, engagement, motivation, and openness of the patient causing high dropout should be considered. TRIAL REGISTRATION: PROSPERO International Prospective Register of Systematic Reviews CRD42021285450; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=285450.

Dental sleep-related conditions and the role of oral healthcare providers: A scoping review.

Dental sleep medicine as a discipline was first described about a quarter of a century ago. Snoring, obstructive sleep apnea, sleep bruxism, xerostomia, hypersalivation, gastroesophageal reflux disease, and orofacial pain were identified as dental sleep-related conditions. This scoping review aimed to: i) identify previously unidentified dental sleep-related conditions; and ii) identify the role of oral healthcare providers in the prevention, assessment, and management of dental sleep-related conditions in adults. A systematic literature search was conducted in PubMed, Embase.com, Web of Science, and Cochrane. Studies that reported an actual or likely role of oral healthcare providers in the prevention, assessment, and/or management of sleep-related conditions were included. Of the 273 included studies, 260 were on previously listed dental sleep-related conditions; the other 13 were on burning mouth syndrome. Burning mouth syndrome was therefore added to the list of dental sleep-related conditions for the first aim and categorized into sleep-related orofacial pain. For the second aim, the role of oral healthcare providers was found to be significant in the prevention, assessment, and management of obstructive sleep apnea and sleep bruxism; in the assessment and management of snoring, sleep-related orofacial pain, and oral dryness; and in the assessment of sleep-related gastroesophageal reflux condition.

Pilot study on the role of somatic modulation in hyperacusis.

BACKGROUND: Hyperacusis is a reduced tolerance to sounds that often co-occurs with tinnitus. Both symptoms have convergent as well as divergent characteristics. Somatic modulation, changes in pitch or loudness during certain movements, is common in patients with a primary complaint of tinnitus. However, thus far, this is not documented in patients with hyperacusis. OBJECTIVES: This study aimed to examine the influence of somatic manoeuvres on the perception of external sounds in patients with a primary complaint of hyperacusis. METHODOLOGY: In this prospective cross-sectional pilot study, 18 patients with a primary complaint of hyperacusis were recruited at the Tinnitus Treatment and Research Center Antwerp (TINTRA). While patients listened to a 1 kHz broadband noise of 30 dB sensation level, six neck manoeuvres (flexion, extension, lateroflexion left/right, traction and compression), three jaw manoeuvres (protrusion, laterotrusion left/right) and one placebo manoeuvre (hand on head) were performed. The primary outcome measure was the change in the perception of the presented sound in terms of loudness and intrusiveness between baseline and each modulation measured by a visual analogue scale (VAS). RESULTS: No overall significant changes were found; however, individual results indicated that five patients presented a clinically relevant change of more than three points out of ten on VAS in terms of hyperacusis after at least one of the executed somatic manoeuvres. CONCLUSIONS: This pilot study did not demonstrate an overall significant change in hyperacusis after somatic manoeuvres but does not rule out the possibility of somatic modulation in some hyperacusis patients. TRIAL REGISTRATION: The protocol of this prospective cross-sectional pilot study was registered on clinicaltrials.gov with registration number NCT04693819.

Hypoglossal nerve stimulation versus positive airway pressure therapy for obstructive sleep apnea.

PURPOSE: Hypoglossal nerve stimulation (HNS) has been shown to treat obstructive sleep apnea (OSA) effectively. The aim of this study was to compare HNS with positive airway pressure (PAP) treatment regarding outcome parameters: (1) sleepiness, (2) apnea-hypopnea index (AHI), and (3) effectiveness. METHODS: Propensity score matching with nearest neighbor algorithm was used to compare outcomes of HNS and PAP therapy in a real-world setting. Data were collected at baseline and 12 months after initiating OSA treatment including demographics, Epworth Sleepiness Scale (ESS), AHI, and objective adherence data. To account for overall treatment efficacy, the mean disease alleviation (MDA) was calculated. RESULTS: Of 227 patients who received treatment consecutively, 126 could be matched 1:1 with regard to age, body mass index, and AHI. After matching, no statistically significant differences between the groups were found. A clinically important symptom improvement was seen at 12 months in both cohorts, though there was a greater difference in ESS improvement in patients treated with HNS (8.0 ± 5.1 points vs. 3.9 ± 6.8 points; p = 0.042). In both groups, mean posttreatment AHI was significantly reduced (HNS: 8.1 ± 6.3/h; PAP: 6.6 ± 8.0/h; p < 0.001). Adherence after 12 months among patients treated with HNS was higher than in those receiving PAP therapy (5.0 ± 2.6 h/night; 4.0 ± 2.1 h/night) but not with statistical significance. Overall effectiveness calculated with the MDA was 59% in patients treated with HNS compared to 51% receiving PAP. CONCLUSION: Patients treated with HNS therapy had significantly greater improvements in daytime sleepiness compared to PAP therapy, while the mean reduction of AHI and overall effectiveness were comparable for both treatments. TRIAL REGISTRATION: ClinicalTrial.gov Identifier: NCT03756805.

A Critical Analysis of Pharyngeal Patterns of Collapse in Obstructive Sleep Apnea: Beyond the Endoscopic Classification Systems.

(1) Background: Drug-Induced Sleep Endoscopy (DISE) enables the three-dimensional and dynamic visualization of the upper airway (UA) during sleep, which is useful in selecting the best treatment option for obstructive sleep apnea (OSA) patients, particularly for surgical procedures. Despite international consensus statements or position papers, a universally accepted DISE methodology and classification system remain a controversial open question. (2) Methods: A review of the English scientific literature on DISE related to endoscopic classification systems and surgical outcome predictors (3) Results: Of the 105 articles, 47 were included in the analysis based on their content's relevance to the searched keywords. (4) Conclusions: A final report and scoring classification system is not universally accepted; the most internationally applied endoscopic classification system during DISE does not cover all patterns of events that occur simultaneously during the endoscopic examination, highlighting that several configurations of collapse and obstruction at different UA levels could be observed during DISE, which should be described in detail if DISE has to be considered in the decision-making process for the UA surgical treatment in OSA patients and if DISE has to have a role as a predictive factor for surgical outcomes analysis.

Dual-site transcranial direct current stimulation to treat tinnitus: a randomized controlled trial.

Transcranial direct current stimulation (tDCS) has been proposed as a potential intervention for subjective tinnitus, but supporting evidence remains limited. We aimed to investigate the effect of anodal high-definition tDCS of the left temporal area and right dorsolateral prefrontal cortex on tinnitus severity. This double-blind randomized controlled trial included 77 patients (age range 18-79, 43 male) with chronic subjective tinnitus as their primary complaint. Thirty-eight subjects received six consecutive sessions of dual-site sequential high-definition-tDCS with electrodes positioned over the left temporal area and right dorsolateral prefrontal cortex. Both areas were stimulated for 15 min per session, with total stimulation time amounting to 30 min. Thirty-nine subjects received sham stimulation. The primary outcome measure was the change in tinnitus severity, as evaluated by the Tinnitus Functional Index, from baseline to a follow-up visit at 8 ± 2 weeks after treatment completion. Secondary outcomes included changes in perceived tinnitus loudness, as measured with a visual analogue scale and a tinnitus matching procedure, as well as scores on the Hospital Anxiety and Depression Scale, and the Hyperacusis Questionnaire. No differences in Tinnitus Functional Index change scores were identified between the active treatment and sham control groups (linear regression: P = 0.86). The Tinnitus Functional Index scores decreased significantly over time in both groups (P = 0.0012), indicating the presence of a considerable placebo effect. These change scores were significantly influenced by sex (linear regression: P = 0.037) and baseline symptoms of anxiety (linear regression: P = 0.049) in both groups. In general, Tinnitus Functional Index scores decreased more profoundly in males and in subjects with a higher degree of anxiety at baseline. None of the included secondary measures differed significantly between experimental arms. Our results suggest that dual-site sequential high-definition-tDCS of the left temporal area and right dorsolateral prefrontal cortex does not alleviate tinnitus severity. Interestingly, in our study population, fluctuations in tinnitus severity were influenced by gender and concurrent mental condition. It is therefore important to take these factors into account when conducting or planning randomized controlled trials in tinnitus populations.

Accuracy of high-risk HPV DNA PCR, p16(INK4a) immunohistochemistry or the combination of both to diagnose HPV-driven oropharyngeal cancer.

BACKGROUND: The incidence of high-risk human papillomavirus (hrHPV)-driven head and neck squamous cell carcinoma, in particular oropharyngeal cancers (OPC), is increasing in high-resource countries. Patients with HPV-induced cancer respond better to treatment and consequently have lower case-fatality rates than patients with HPV-unrelated OPC. These considerations highlight the importance of reliable and accurate markers to diagnose truly HPV-induced OPC. METHODS: The accuracy of three possible test strategies, i.e. (a) hrHPV DNA PCR (DNA), (b) p16(INK4a) immunohistochemistry (IHC) (p16), and (c) the combination of both tests (considering joint DNA and p16 positivity as positivity criterion), was analysed in tissue samples from 99 Belgian OPC patients enrolled in the HPV-AHEAD study. Presence of HPV E6*I mRNA (mRNA) was considered as the reference, indicating HPV etiology. RESULTS: Ninety-nine OPC patients were included, for which the positivity rates were 36.4%, 34.0% and 28.9% for DNA, p16 and mRNA, respectively. Ninety-five OPC patients had valid test results for all three tests (DNA, p16 and mRNA). Using mRNA status as the reference, DNA testing showed 100% (28/28) sensitivity, and 92.5% (62/67) specificity for the detection of HPV-driven cancer. p16 was 96.4% (27/28) sensitive and equally specific (92.5%; 62/67). The sensitivity and specificity of combined p16 + DNA testing was 96.4% (27/28) and 97.0% (65/67), respectively. In this series, p16 alone and combined p16 + DNA missed 1 in 28 HPV driven cancers, but p16 alone misclassified 5 in 67 non-HPV driven as positive, whereas combined testing would misclassify only 2 in 67. CONCLUSIONS: Single hrHPV DNA PCR and p16(INK4a) IHC are highly sensitive but less specific than using combined testing to diagnose HPV-driven OPC patients. Disease prognostication can be encouraged based on this combined test result.

Bilateral vs Unilateral Hypoglossal Nerve Stimulation in Patients With Obstructive Sleep Apnea.

Objective: Unilateral hypoglossal nerve stimulation (uniHNS) is an effective treatment for obstructive sleep apnea. Bilateral hypoglossal nerve stimulation (biHNS) is a novel therapeutic option and a different approach to hypoglossal nerve stimulation. The aim of this study was to analyze the clinical outcome of the first 10 biHNS cases vs the first 10 uniHNS cases ever implanted. Study Design: Prospective data analysis. Setting: International multicenter comparative clinical trial. Methods: The first 10 patients in 2020 who received a biHNS device (Genio System; Nyxoah) and the first 10 patients in 2014 who received a uniHNS system (Inspire II; Inspire Medical Systems) were included. Treatment outcome was evaluated at 3 months after surgery. Data collection included demographics, apnea hypopnea index (AHI), oxygen saturation and desaturation index, Epworth Sleepiness Scale, and adverse events. Results: The mean ± SD age was 52.1 ± 9.6 years (biHNS) and 58.3 ± 8.6 years (uniHNS). The mean body mass index was 26.4 ± 5.6 kg/m2 (biHNS) and 26.2 ± 2.2 kg/m2 (uniHNS). The mean preimplantation AHI (biHNS, 39.9 ± 14.8/h; uniHNS, 32.2 ± 11.0/h) decreased in both groups after 3 months (biHNS, 19.2 ± 14.0/h, P = .008; uniHNS, 13.1 ± 16.8/h, P = .037) with no significant difference between groups (P = .720). The mean preimplantation Epworth Sleepiness Scale (biHNS, 11.8 ± 6.2; uniHNS, 11.1 ± 4.9) decreased as well after 3 months (biHNS, 9.4 ± 6.3; uniHNS, 6.0 ± 5.0). Conclusion: Preliminary postmarket data suggest that biHNS may be as safe and effective as uniHNS. Long-term follow-up in a larger sample size is required to assess the stability of biHNS.