Patient-reported experience with hypoglossal nerve stimulation in the treatment of obstructive sleep apnea.

BACKGROUND: Breathing-synchronized hypoglossal nerve stimulation (HNS) is routinely used as an alternative treatment for patients with obstructive sleep apnea (OSA). Significant and clinically relevant improvements in disease severity and OSA symptoms such as daytime sleepiness as well as overall quality of life have been reported in randomized-controlled trials and large real-world cohort studies. However, so far, few data exist on patient-reported experience with the treatment. METHODS: A structured survey with 22 questions was constructed using five-level Likert scales (1 = no agreement, 5 = complete agreement) to evaluate patient experience with HNS and perception of the treatment in the domains "Overall experience with therapy," "Experience with treatment process," and "Side-effects from treatment." Additional data were collected on current symptom status, measured with Epworth sleepiness scale (ESS) questionnaire, and OSA disease history. Multiple linear regression analysis was conducted to test associations of medical variables and response behavior. Correlations between variables and domains, as well as individual items, were assessed using Spearman rank test. RESULTS: A total of 75 patients from Germany who were treated with breathing-synchronized HNS were enrolled (mean age 57.3 years, 78% male), and 71 questionnaires with complete data were included for analysis. Two-thirds of participants (67%) had a history of OSA history for 5 years or longer. Of all patients, 76% had normalized OSA symptoms at time of the study (ESS: 6.4 ± 5.0) and 98% reported using stimulation therapy every night. Regression analysis revealed an association of current symptoms measured with ESS and response behavior. Hence, patients with normalized daytime sleepiness reported significantly more positive experience across all domains assessed, compared to patients with residual daytime sleepiness. Overall, only 2% of participants reported side effects that made them reduce or discontinue stimulation therapy. The rate of reported side effects was associated with current symptom control under therapy. CONCLUSIONS: Overall patient-reported experience with breathing-synchronized HNS therapy was positive and high satisfaction with the treatment process was observed. Side effects occurred, but rarely affected subjective use of the therapy or satisfaction. Subjective experience and perception are influenced by residual daytime sleepiness with stimulation therapy.

Patient-reported outcomes with hypoglossal nerve stimulation for treatment of obstructive sleep apnea: a systematic review and meta-analysis.

INTRODUCTION: Hypoglossal nerve stimulation (HNS) has recently been introduced as an alternative treatment for patients with OSA. A large number of studies have demonstrated substantial changes in OSA with this therapy by reducing respiratory events and improving symptoms such as daytime sleepiness and quality of life. The objective of this review was to conduct a systematic review and meta-analysis to evaluate patient-reported outcomes and experience with HNS therapy. METHODS: A systematic literature search of MEDLINE, Cochrane, and Web of Science was performed to identify randomized controlled and observational studies reporting subjective outcomes with different HNS systems in patients with OSA. Abstracts of 406 articles were screened and a subset of 55 articles were reviewed for eligibility. Risk of bias was assessed using the ROBINS-I tool. Meta-analysis using RevMan was performed when > 2 studies were identified that reported data on a specific outcome. RESULTS: Thirty-four publications reporting data on 3785 patients with a mean follow-up of 11.8 ± 12.2 months were identified and included in the meta-analysis. The analysis revealed a pooled effect of 4.59 points improvement in daytime sleepiness as measured by the ESS questionnaire (Z = 42.82, p < .001), 2.84 points improvement in daytime functioning as measured by the FOSQ score (Z = 28.38, p < .001), and 1.77 points improvement in sleep quality as measured by the PSQI questionnaire (Z = 2.53, p = .010). Patient-reported experience was consistently positive and revealed additional relevant aspects from this perspective. CONCLUSION: HNS therapy significantly improves quality of life in patients with OSA and reliably produces clinically meaningful effects on daytime sleepiness, daytime functioning, and sleep quality. Treatment regularly meets or exceeds the minimum clinically important differences defined for the respective instruments. Additional research is needed to further investigate effects on quality of life beyond improvements in daytime sleepiness and daytime functioning.

Tailoring the escape rate of a Brownian particle by combining a vortex flow with a magnetic field.

The probability per unit time for a thermally activated Brownian particle to escape over a potential well is, in general, well-described by Kramers's theory. Kramers showed that the escape time decreases exponentially with increasing barrier height. The dynamics slow down when the particle is charged and subjected to a Lorentz force due to an external magnetic field. This is evident via a rescaling of the diffusion coefficient entering as a prefactor in the Kramers's escape rate without any impact on the barrier-height-dependent exponent. Here, we show that the barrier height can be effectively changed when the charged particle is subjected to a vortex flow. While the vortex alone does not affect the mean escape time of the particle, when combined with a magnetic field, it effectively pushes the fluctuating particle either radially outside or inside depending on its sign relative to that of the magnetic field. In particular, the effective potential over which the particle escapes can be changed to a flat, a stable, and an unstable potential by tuning the signs and magnitudes of the vortex and the applied magnetic field. Notably, the last case corresponds to enhanced escape dynamics.

Theory of chain walking catalysis: From disordered dendrimers to dendritic bottle-brushes.

The chain walking (CW) polymerization technique has the unique property of a movable catalyst synthesizing its own path by creating branch-on-branch structures. By successive attachment of monomers, the resulting architecture ranges from dendritic to linear growth depending on the walking rate, which is defined by the ratio of walking steps and reaction events of the catalyst. The transition regime is characterized by local dendritic sub-structures (dendritic blobs) and a global linear chain feature forming a dendritic bottle-brush. A scaling model for structures obtained by CW catalysis is presented and validated by computer simulation relating the extensions of CW structures to the catalyst's walking ability. The limiting case of linear (low walking rate) and dendritic growth (high walking rate) is recovered, and the latter is shown to bear analogies to the Barabási-Albert graph and Bernoulli growth random walk. We could quantify the size of the dendritic blob as a function of the walking rate by using spectral properties of the connectivity matrix of the simulated macromolecules. This allows us to fit the numerical constants in the scaling approach. We predict that independent of the underlying chemical process, all CW polymerization syntheses involving a highly mobile catalyst ultimately result in bottle-brush structures whose properties depend on a unique parameter: the walking rate.

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.

The relationship between obstructive sleep apnea with hearing and balance: A scoping review.

BACKGROUND: Obstructive sleep apnea (OSA) has been linked to multiple co-morbidities, and some research points to a potential relationship between OSA and hearing and balance dysfunction, and the benefits of continuous positive airway pressure (CPAP) treatment. OBJECTIVE: The present study was undertaken as a scoping review of research on OSA and its impact on hearing and balance function in adults and children and whether the treatment of CPAP would affect hearing and balance function. METHOD: Online databases were used to identify 45 papers published that used hearing and balance assessments concerning OSA and CPAP therapy as a primary outcome. The secondary outcome was the subjective perception through validated questionnaires. RESULTS: Whilst the data on the effect of OSA on middle ear function remains inconclusive, most papers demonstrate an increase in hearing thresholds, an absence of otoacoustic emissions (OAE) and delayed auditory brainstem response (ABR) in adults with OSA. Nystagmus and abnormal vestibular evoked myogenic potentials (VEMPs) were observed in the small number of papers. The positive pressure from CPAP significantly and transiently increases middle ear pressure, however, its effects on other auditory regions and the vestibular system remains inconclusive. Research on hearing and balance function in children with OSA is limited. CONCLUSIONS: Narrow assessments of hearing and balance are not sufficient to understand the nature of hearing and balance function in OSA patients and the effect of CPAP therapy. More comprehensive assessments are necessary to observe peripheral and central changes in the auditory and vestibular pathways.

Sleep position, patient comfort, and technical performance with two established procedures for home sleep testing.

PURPOSE: In patients with a high pre-test probability of suffering from obstructive sleep apnea (OSA), (cardio)-respiratory polygraphy (RP; level 3) is commonly used for home sleep testing (HST); however, testing based on peripheral arterial tonometry (PAT) is increasingly recognized as an alternative method. The aim of the study was to compare sleep position, patients' comfort, and technical failure rates of HST with RP and PAT in patients with suspected OSA. METHODS: Sleep position, patients' comfort, and technical failure rates of RP and PAT were compared in 56 patients receiving two nights of HST with either RP or PAT in a randomized fashion. RESULTS: Time in supine position with PAT was significantly lower (173.7±88 min) compared to RP (181.7±103.7 min; p < 0.001), although the absolute mean difference was not clinically significant. Patients reported to sleep better, feeling less disturbed when falling asleep, losing less sensors, and fewer nightly awakenings with PAT, but experienced more pain at the side of the finger probe. Forty-five out of 56 patients (80%) rated PAT as being the superior sleep test and 49 out of 56 (88%) would prefer PAT for further investigations (p<0.001). PAT testing was associated with less technical failures. CONCLUSION: The results demonstrate that HST with PAT leads to less time in supine sleep positioning, which may be clinically relevant in selected patients. Moreover, PAT is associated with less technical failures and is perceived with less discomfort during testing and a reduced number of nocturnal awakenings in patient self-reports.

Effects of tranexamic acid on human nasal ciliary beat frequency.

BACKGROUND: Patients with recurrent epistaxis, particularly due to hereditary hemorrhagic telangiectasia (HHT) are recommended to apply topical tranexamic acid (TXA) to reduce bleeding events. Those patients may suffer ciliary dysfunction due to TXA's effects on ciliary beating frequency (CBF) and their consequences. METHODOLOGY/PRINCIPAL: Human nasal epithelial cells were harvested with a nasal brush in 30 healthy subjects. We investigated the CBF in RPMI medium using high-frequency video microscopy. TXA was added to the cells in various concentrations ranging from 2 to 5%, including the therapeutic concentration (2%) and a control (0%). RESULTS: CBF in the control condition was 6.1 ± 1.6 Hz. TXA reduces CBF in a time and concentration dependent manner, to, e.g. 4.3 ± 1.2 Hz with 2% TXA and 3.3 ± 0.9 Hz with 5% TXA after 16-20 min. The differences in CBF were statistically significant for all concentrations of TXA. CONCLUSIONS: TXA has the potential to significantly impair nasal epithelial function. Therefore, frequent or regular topical nasal application of TXA should be done under close monitoring of nasal function, especially in patients with co-morbidities like chronic rhinosinusitis.

Understanding the clinical reasoning processes involved in the management of multimorbidity in an ambulatory setting: study protocol of a stimulated recall research.

BACKGROUND: Primary care physicians are at the very heart of managing patients suffering from multimorbidity. However, several studies have highlighted that some physicians feel ill-equipped to manage these kinds of complex clinical situations. Few studies are available on the clinical reasoning processes at play during the long-term management and follow-up of patients suffering from multimorbidity. This study aims to contribute to a better understanding on how the clinical reasoning of primary care physicians is affected during follow-up consultations with these patients. METHODS: A qualitative research project based on semi-structured interviews with primary care physicians in an ambulatory setting will be carried out, using the video stimulated recall interview method. Participants will be filmed in their work environment during a standard consultation with a patient suffering from multimorbidity using a "button camera" (small camera) which will be pinned to their white coat. The recording will be used in a following semi-structured interview with physicians and the research team to instigate a stimulated recall. Stimulated recall is a research method that allows the investigation of cognitive processes by inviting participants to recall their concurrent thinking during an event when prompted by a video sequence recall. During this interview, participants will be prompted by different video sequence and asked to discuss them; the aim will be to encourage them to make their clinical reasoning processes explicit. Fifteen to twenty interviews are planned to reach data saturation. The interviews will be transcribed verbatim and data will be analysed according to a standard content analysis, using deductive and inductive approaches. CONCLUSION: Study results will contribute to the scientific community's overall understanding of clinical reasoning. This will subsequently allow future generation of primary care physicians to have access to more adequate trainings to manage patients suffering from multimorbidity in their practice. As a result, this will improve the quality of the patient's care and treatments.

Maximum isometric tongue force in patients with obstructive sleep apnoea.

BACKGROUND: Obstructive sleep apnea (OSA) is a sleep disorder with a prevalence of 9-38%. The underlying pathology in OSA is a collapse of the upper airway. Especially in more severely affected patients, this collapse is often located at the level of the tongue base. Therefore, various implantable systems (anchors and ligament techniques) were developed to prevent or overcome this collapse. These systems are exposed to various forces. Different models have been developed to measure these forces and data comparing forces in healthy individuals with OSA patients are rare. PURPOSE: Purpose of the study was to evaluate possible differences in tongue forces between healthy individuals and patients with OSA. METHOD: To evaluate maximum isometric tongue forces, we conducted a matched pair design study including 20 healthy individuals and 20 patients suffering from OSA. Maximum isometric tongue forces were measured in an anterior/posterior direction with the help of self-designed new device that clamps the tongue. RESULTS: We could show that the maximum isometric force does not differ significantly in healthy individuals (10.7 ± 5.2N) from patients with OSA (14.4 ± 6.3N). CONCLUSION: Currently there are no indications that maximum isometric tongue force does differ in healthy individuals and patients with OSA. Higher, as well as lower, tongue forces in patients with OSA seem not to differ from healthy subjects and therefore may not be needed to consider, in the development of tongue management devices, for OSA patients.

Diagnosis and treatment of isolated snoring-open questions and areas for future research.

STUDY OBJECTIVES: Snoring is a common phenomenon which is generated by vibration of soft tissue of the upper airway during sleep. Due to the high incidence of isolated snoring and the substantial burden for the patient and the bed partner, a thorough examination and appropriate therapy are required. Many recommendations for the treatment of isolated snoring are either not evidence-based or are derived from recommendations for the management of obstructive sleep apnea. Therefore, the aim of this study is the identification and description of open questions in the diagnosis and treatment of isolated snoring and the illustration of areas for further research. METHODS: In the context of the development of the new version of the German guideline "Diagnosis and treatment of isolated snoring in adults," a multidisciplinary team of experts performed a systematic literature search on the relevant medical data and rated the current evidence regarding the key diagnostic and therapeutic measures for snoring. RESULTS: The systematic literature review identified 2293 articles. As a major inclusion criterion, only studies on primary snoring based on objective sleep medical assessment were selected. After screening and evaluation, 33 full-text articles remained for further analysis. Based on these articles, open questions and areas for future research were identified for this review. CONCLUSION: Several major gaps in the literature on the diagnosis and treatment of isolated snoring were identified. For the majority of diagnostic and therapeutic measures for snoring, high-level scientific evidence is still lacking.

Cocaine Reduces Ciliary Beat Frequency of Human Nasal Epithelial Cells.

BACKGROUND/AIM: Cocaine is a widely used recreational drug and is known for its nasal complications including epithelial, cartilage and bone damage. The aim of the study was to analyze the impact of cocaine on ciliary beat frequency (CBF) of human nasal epithelial cells and therefore better understand its side effects on nasal mucosa. MATERIALS AND METHODS: Nasal epithelial cells of 21 healthy subjects were harvested and exposed in vitro to cocaine hydrochloride solutions ranging from 0.875% to 7%. High-speed video footage was acquired with phase contrast microscopy and CBF was analyzed with Sissons-Ammons Video Analysis (SAVA) software. RESULTS: All tested concentrations led to a significant reduction in CBF compared to the control. Effects increased over time and with concentration. A mechanical inhibition of cilia by cocaine crystals was also observed. CONCLUSION: We assume that CBF reduction is part of the pathomechanism leading to nasal complications in cocaine abuse. Considering these results, clinical usage of cocaine should be critically evaluated and restricted to select cases only.

Apoptosis-related Proteins Are Altered by Selective Tyrosine Kinase Inhibitors and Everolimus in HPV-dependent SCC.

BACKGROUND: Head and neck squamous cell cancer (HNSCC) affects the oral cavity and the pharynx. The aim of the study was to investigate the effects of selective tyrosine kinase inhibitors (TKIs) erlotinib, gefitinib, nilotinib and dasatinib and the mammalian target of rapamycin (mTOR) inhibitor everolimus on the expression of apoptosis-related proteins caspase-3, FAS cluster of differentiation (CD)-95 and FAS ligand in human papilloma virus (HPV)-dependent squamous cancer. MATERIALS AND METHODS: Two HPV-negative cell lines (UMSCC-11A/-14C) and one HPV-positive cell line (CERV196) were incubated with TKIs or everolimus and protein concentrations of target proteins were analyzed with enzyme-linked immunosorbent assay (ELISA). RESULTS: Caspase-3 was affected by the tested TKIs in HPV-positive SCC, whereas FAS CD95 and FAS ligand were influenced in HPV-negative SCC. DISCUSSION: This is the first study to analyze the influence of TKIs and everolimus on key proteins of apoptosis. Our results provide novel information contributing to a better understanding of the cell biology of HPV-dependent HNSCC and might contribute to the discovery of novel pharmaceutical treatment strategies for HNSCC.

Changes in breath cycle sensing affect outcomes in upper airway stimulation in sleep apnea.

BACKGROUND: Upper Airway Stimulation (UAS) is a well-established therapy option for obstructive sleep apnea (OSA). AIMS: There are no data on whether respiratory sensing contributes to successful UAS therapy. MATERIALS & METHODS: After initial measurements of 3 implanted patients (M1), the sensing signal was inverted (M2) without changing other parameters. Two weeks later, the signal was converted back again, and the sensitivity of breathing cycle detection was turned to a very low state (M3). RESULTS: At M2 and M3, the apnea-hypopnea index and oxygen desaturation index increased. DISCUSSION: Correct respiratory sensing is important for controlling OSA using UAS. CONCLUSIONS: Therefore, implant centers should should optimize respiratory sensing placement and adjustment.

Nondiffusive fluxes in a Brownian system with Lorentz force.

The Fokker-Planck equation provides a complete statistical description of a particle undergoing random motion in a solvent. In the presence of Lorentz force due to an external magnetic field, the Fokker-Planck equation picks up a tensorial coefficient, which reflects the anisotropy of the particle's motion. This tensor, however, cannot be interpreted as a diffusion tensor; there are antisymmetric terms which give rise to fluxes perpendicular to the density gradients. Here, we show that for an inhomogeneous magnetic field these nondiffusive fluxes have finite divergence and therefore affect the density evolution of the system. Only in the special cases of a uniform magnetic field or carefully chosen initial condition with the same full rotational symmetry as the magnetic field can these fluxes be ignored in the density evolution.

Incidence and temporal trends of co-occurring personality disorder diagnoses in immune-mediated inflammatory diseases.

AIMS: Although immune-mediated inflammatory diseases (IMID) are associated with multiple mental health conditions, there is a paucity of literature assessing personality disorders (PDs) in these populations. We aimed to estimate and compare the incidence of any PD in IMID and matched cohorts over time, and identify sociodemographic characteristics associated with the incidence of PD. METHODS: We used population-based administrative data from Manitoba, Canada to identify persons with incident inflammatory bowel disease (IBD), multiple sclerosis (MS) and rheumatoid arthritis (RA) using validated case definitions. Unaffected controls were matched 5:1 on sex, age and region of residence. PDs were identified using hospitalisation or physician claims. We used unadjusted and covariate-adjusted negative binomial regression to compare the incidence of PDs between the IMID and matched cohorts. RESULTS: We identified 19 572 incident cases of IMID (IBD n = 6,119, MS n = 3,514, RA n = 10 206) and 97 727 matches overall. After covariate adjustment, the IMID cohort had an increased incidence of PDs (incidence rate ratio [IRR] 1.72; 95%CI: 1.47-2.01) as compared to the matched cohort, which remained consistent over time. The incidence of PDs was similarly elevated in IBD (IRR 2.19; 95%CI: 1.69-2.84), MS (IRR 1.79; 95%CI: 1.29-2.50) and RA (IRR 1.61; 95%CI: 1.29-1.99). Lower socioeconomic status and urban residence were associated with an increased incidence of PDs, whereas mid to older adulthood (age 45-64) was associated with overall decreased incidence. In a restricted sample with 5 years of data before and after IMID diagnosis, the incidence of PDs was also elevated before IMID diagnosis among all IMID groups relative to matched controls. CONCLUSIONS: IMID are associated with an increased incidence of PDs both before and after an IMID diagnosis. These results support the relevance of shared risk factors in the co-occurrence of PDs and IMID conditions.

Reflex swallowing elicited by electrical stimulation in obstructive sleep apnea patients: A preliminary study.

This study tested whether electrical stimulation of the pharyngeal mucosa is able to induce reliably the swallowing reflex in awake and asleep obstructive sleep apnea (OSA) patients, and whether the induced reflexes affect the sleep variables. In addition, the latency, occurrence, and morphology of swallows were evaluated. Eight patients received an esophageal catheter that was used on three consecutive nights for electrical stimulation and manometric recordings. The electrical stimulation proved itself safe, but its efficiency in inducing swallows sank from 80.0 % in awake to 37.4 % in sleeping subjects and was lowest in the sleep stage N3. The swallowing reflex was triggered with a mean latency of 3.69 ± 0.70 s, was predominantly induced in the hyperventilation phase, and had no significant effect on the subject's sleep variables. These findings indicate that electrical stimulation can more effectively trigger the swallowing reflex while the subjects are awake than during sleep without showing remarkable clinical benefits in terms of apnea-hypopnea index (AHI) improvement.

Previous Surgery and Hypoglossal Nerve Stimulation for Obstructive Sleep Apnea.

OBJECTIVE: To examine whether previous palate or hypopharyngeal surgery was associated with efficacy of treatment of obstructive sleep apnea with hypoglossal nerve stimulation. STUDY DESIGN: Cohort (retrospective and prospective). SETTING: Eleven academic medical centers. SUBJECTS AND METHODS: Adults treated with hypoglossal nerve stimulation were enrolled in the ADHERE Registry. Outcomes were defined by the apnea-hypopnea index (AHI), in 3 ways: change in the AHI and 2 definitions of therapy response requiring ≥50% reduction in the AHI to a level <20 events/h (Response20) or 15 events/h (Response15). Previous palate and hypopharyngeal (tongue, epiglottis, or maxillofacial) procedures were documented. Linear and logistic regression examined the association between previous palate or hypopharyngeal surgery and outcomes, with adjustment for age, sex, and body mass index. RESULTS: The majority (73%, 217 of 299) had no previous palate or hypopharyngeal surgery, while 25% and 9% had previous palate or hypopharyngeal surgery, respectively, including 6% with previous palate and hypopharyngeal surgery. Baseline AHI (36.0 ± 15.6 events/h) decreased to 12.0 ± 13.3 at therapy titration (P < .001) and 11.4 ± 12.6 at final follow-up (P < .001). Any previous surgery, previous palate surgery, and previous hypopharyngeal surgery were not clearly associated with treatment response; for example, any previous surgery was associated with a 0.69 (95% CI: 0.37, 1.27) odds of response (Response20 measure) at therapy titration and a 0.55 (95% CI: 0.22, 1.34) odds of response (Response20 measure) at final follow-up. CONCLUSION: Previous upper airway surgery was not clearly associated with efficacy of hypoglossal nerve stimulation.

Preventative and medical treatment of ear disease in remote or resource-constrained environments.

BACKGROUND: Important ear problems can affect the outer ear, the middle ear and the inner ear. Globally, the greatest burden of disease is due to ear conditions that are associated with otorrhoea and hearing loss. METHODS: This study reviewed the literature on the prevention and treatment of common ear conditions that are most relevant to settings with high rates of ear disease and limited resources. The grading of recommendations assessment, development and evaluation ('GRADE') approach was utilised to assess interventions. RESULTS: Accurate diagnosis of ear disease is challenging. Much of the preventable burden of ear disease is associated with otitis media. Nine otitis media interventions for which there is moderate to high certainty of effect were identified. While most interventions only provide modest benefit, the impact of treatment is more substantial in children with acute otitis media with perforation and chronic suppurative otitis media. CONCLUSION: Disease prevention through good hygiene practices, breastfeeding, reducing smoke exposure, immunisation and limiting noise exposure is recommended. Children with acute otitis media with perforation, chronic suppurative otitis media, complications of otitis media, and significant hearing loss should be prioritised for medical treatment.

Implantation of the nyxoah bilateral hypoglossal nerve stimulator for obstructive sleep apnea.

OBJECTIVES: This report describes the surgical implantation of a novel bilateral hypoglossal nerve stimulator (Genio system®, Nyxoah S.A., Belgium) and the successful treatment of a patient with moderate obstructive sleep apnea (OSA). STUDY DESIGN: Surgical technique description and case study report. METHODS: The bilateral implantable stimulator (IS) simultaneously stimulates both genioglossus (GG) muscles to reduce airway obstruction. At night, patients wear an activation chip under their chin that wirelessly transmits energy to the implant and enables the nerve stimulation. Surgical implantation of the IS is performed under general anesthesia by making a small incision above the hyoid bone and dissecting through the platysma, mylohyoid, and geniohyoid muscles to the GG muscle. The hypoglossal nerve branches are then identified, followed by suturing the IS in place. The system was evaluated in an otherwise healthy, 60-year-old woman with moderate OSA (apnea hypopnea index (AHI): 25/hr, nadir O2 saturation: 78%). Appropriate stimulation settings were determined at 2-, 3-, and 6-months post implantation during polysomnography (PSG) and changes in apnea and hypopnea events and oxygen desaturation recorded. RESULTS: The surgery was well tolerated by the patient with an uneventful recovery. The PSG at 6 months showed that AHI per hour, obstructive apnea events per hour, hypopnea events per hour, and oxygen desaturation index have been reduced by 88%, 92%, 88%, and 97%, respectively, and nadir O2 saturation improved to 91%. CONCLUSIONS: The absence of complications and considerable reduction of apnea and hypopnea events in this case study help demonstrate the potential safety and efficacy of the bilateral hypoglossal nerve stimulator. LEVEL OF EVIDENCE: 4.