Australasian Sleep Association position statement on consensus and evidence based treatment for primary snoring.

Primary snoring impacts a significant portion of the adult population and has the potential to significantly impair quality of life. The purpose of these guidelines is to provide evidence-based recommendations to assist Australasian practitioners in the management of adult patients who present with primary snoring without significant obstructive sleep apnoea. The Timetable, Methodology and Standards by which this Position Statement has been established is outlined in the Appendix S1. The main recommendations are: Weight loss, and reduced alcohol consumption should be recommended, where appropriate If clinical judgement dictates, benzodiazepine and opioid reduction or avoidance may be advised Positional therapy should be considered in supine dominant snorers In dentate patients, Mandibular advancement devices (MAD) should be recommended as a first line treatment following assessment by both an appropriate Dentist and Sleep physician Continuous positive airway pressure (CPAP) devices may be recommended in patients with primary snoring in those already committed to their use or willing to try Surgical treatment of primary snoring by an appropriately credentialled surgeon may be advised and includes nasal (adjunctive), palatal and other interventions This position statement has been designed based on the best available current evidence and our combined expert clinical experience to facilitate the management of patients who present with primary snoring. It provides clinicians with a series of both non-surgical and surgical options with the aim of achieving optimal symptom control and patient outcomes. This is the first such set of recommendations to be established within Australasia and has also been reviewed and endorsed by the Australasian Sleep Association.

Incidence of allergen-specific and total immunoglobulin E positivity in children undergoing adenotonsillectomy.

AIM: To conduct a prospective, consecutive cohort study to evaluate the incidence of allergen-specific and total immunoglobulin E (IgE) in a paediatric population undergoing adenotonsillectomy for sleep-disordered breathing. METHODS: A total of 64 consecutive patients presenting for adenotonsillectomy at a single centre were recruited over a period of 3 months. All patients underwent adenotonsillectomy and had allergen-specific and total IgE serum testing at the time of anaesthesia induction. Pre-operative history and examination were conducted to determine clinical allergy. Caregivers completed the Sleep-Related Breathing Disorder scale of the Paediatric Sleep Questionnaire and the Mini Rhinoconjunctivitis Quality of Life Questionnaire at baseline and at 6 weeks post-operatively. RESULTS: A total of 37 (57.8%) patients had either allergen-specific or total IgE positivity. House dust mite was the most prevalent allergen-specific IgE finding, being present in moderate to high levels in 14 (21.9%) patients. A total of 17 (26.6%) patients had a history of atopy, while 34 (53.1%) had examination findings suggestive of allergy. Neither serum IgE testing nor clinical history and examination were independently associated with residual symptoms post adenotonsillectomy. Patients with concomitant serum IgE positivity and clinical allergy had higher residual symptom scores compared to those who did not using both Sleep-Related Breathing Disorder scale of the Paediatric Sleep Questionnaire (P = 0.035) and Mini Rhinoconjunctivitis Quality of Life Questionnaire (P = 0.02) questionnaires. CONCLUSIONS: Our prospective, consecutive cohort of patients reflect a greater incidence of serum IgE positivity compared to historical figures. When utilised with clinical findings on history and examination, serum IgE is a useful adjunct that is associated with greater residual symptoms post-adenotonsillectomy.

Bilateral hypoglossal nerve stimulation for treatment of adult obstructive sleep apnoea.

BACKGROUND AND AIM: Hypoglossal nerve stimulation (HNS) decreases obstructive sleep apnoea (OSA) severity via genioglossus muscle activation and decreased upper airway collapsibility. This study assessed the safety and effectiveness at 6 months post-implantation of a novel device delivering bilateral HNS via a small implanted electrode activated by a unit worn externally, to treat OSA: the Genio™ system. METHODS: This prospective, open-label, non-randomised, single-arm treatment study was conducted at eight centres in three countries (Australia, France and the UK). Primary outcomes were incidence of device-related serious adverse events and change in the apnoea-hypopnoea index (AHI). The secondary outcome was the change in the 4% oxygen desaturation index (ODI). Additional outcomes included measures of sleepiness, quality of life, snoring and device use. This trial was registered with ClinicalTrials.gov, number NCT03048604. RESULTS: 22 out of 27 implanted participants (63% male, aged 55.9±12.0 years, body mass index (BMI) 27.4±3.0 kg·m-2) completed the protocol. At 6 months BMI was unchanged (p=0.85); AHI decreased from 23.7±12.2 to 12.9±10.1 events·h-1, a mean change of 10.8 events·h-1 (p<0.001); and ODI decreased from 19.1±11.2 to 9.8±6.9 events·h-1, a mean change of 9.3 events·h-1 (p<0.001). Daytime sleepiness (Epworth Sleepiness Scale; p=0.01) and sleep-related quality of life (Functional Outcomes of Sleep Questionnaire-10; p=0.02) both improved significantly. The number of bed partners reporting loud, very intense snoring, or leaving the bedroom due to participant snoring decreased from 96% to 35%. 91% of participants reported device use >5 days per week, and 77% reported use for >5 h per night. No device-related serious adverse events occurred during the 6-month post-implantation period. CONCLUSIONS: Bilateral HNS using the Genio™ system reduces OSA severity and improves quality of life without device-related complications. The results are comparable with previously published HNS systems despite minimal implanted components and a simple stimulation algorithm.

Surgical management of obstructive sleep apnoea: A position statement of the Australasian Sleep Association.

Surgery for adult obstructive sleep apnoea (OSA) plays a key role in contemporary management paradigms, most frequently as either a second-line treatment or in a facilitatory capacity. This committee, comprising two sleep surgeons and three sleep physicians, was established to give clarity to that role and expand upon its appropriate use in Australasia. This position statement has been reviewed and approved by the Australasian Sleep Association (ASA) Clinical Committee.

Advances in Pharyngeal Surgery Over the Past 10 Years: New Techniques and Technology.

This article is a review of advances in pharyngeal surgery over the past 10 years regarding literature, surgical technique, assessment, collaboration, and future direction in the management of adult and pediatric obstructive sleep apnea.

Sleep apnea multi-level surgery trial: long-term observational outcomes.

STUDY OBJECTIVES: The sleep apnea multi-level surgery (SAMS) randomized clinical trial showed surgery improved outcomes at 6 months compared to ongoing medical management in patients with moderate or severe obstructive sleep apnea (OSA) who failed continuous positive airway pressure therapy. This study reports the long-term outcomes of the multi-level surgery as a case series. METHODS: Surgical participants were reassessed >2 years postoperatively with the same outcomes reported in the main SAMS trial. Primary outcomes were apnea-hypopnea index (AHI) and Epworth sleepiness scale (ESS), with secondary outcomes including other polysomnography measures, symptoms, quality of life, and adverse events. Long-term effectiveness (baseline to long-term follow-up [LTFU]) and interval changes (6 month to LTFU) were assessed using mixed effects regression models. Control participants were also reassessed for rate of subsequent surgery and outcomes. RESULTS: 36/48 (75%) of surgical participants were reevaluated (mean (standard deviation)) 3.5 (1.0) years following surgery, with 29 undergoing polysomnography. AHI was 41/h (23) at preoperative baseline and 21/h (18) at follow-up, representing persistent improvement of -24/h (95% CI -32, -17; p < 0.001). ESS was 12.3 (3.5) at baseline and 5.5 (3.9) at follow-up, representing persistent improvement of -6.8 (95% CI -8.3, -5.4; p < 0.001). Secondary outcomes were improved long term, and adverse events were minor. Interval change analysis suggests stability of outcomes. 36/43 (84%) of the control participants were reevaluated, with 25 (69%) reporting subsequent surgery, with symptom and quality of life improvements. CONCLUSION: Multi-level upper airway surgery improves OSA burden with long-term maintenance of treatment effect in adults with moderate or severe OSA in whom conventional therapy failed. CLINICAL TRIAL: Multi-level airway surgery in patients with moderate-severe obstructive sleep apnea (OSA) who have failed medical management to assess change in OSA events and daytime sleepiness; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=366019&isReview=true; ACTRN12614000338662.

Surgery for adult obstructive sleep apnoea.

Surgery rarely cures OSA, but the lack of cure should not be judged as failure. New higher-level evidence shows excellent clinical outcomes with surgery, in long-term health, short-term symptoms and quality of life, even when complete cure is not achieved. It is unrealistic and inappropriate to expect that surgery must result in a cure to be considered worthwhile. Evaluating surgical treatments is complicated because placebo control is usually not feasible with invasive therapies, randomisation to or away from invasive therapy may limit patient enrolment and generalisability, and surgery is a heterogeneous array of procedures and combinations of procedures. Despite these testing challenges, well controlled studies are showing important benefits of surgery and, moreover, of combinations of surgical procedures.

Mean disease alleviation between surgery and continuous positive airway pressure in matched adults with obstructive sleep apnea.

STUDY OBJECTIVES: Polysomnography parameters measure treatment efficacy for obstructive sleep apnea (OSA), such as reduction in apnea-hypopnea index (AHI). However, for continuous positive airway pressure (CPAP) therapy, polysomnography measures do not factor in adherence and thus do not measure effectiveness. Mean disease alleviation (MDA) corrects polysomnography measures for CPAP adherence and was used to compare treatment effectiveness between CPAP and multilevel upper airway surgery. METHODS: This retrospective cohort study consisted of a consecutive sample of 331 patients with OSA managed with multilevel airway surgery as second-line treatment (N = 97) or CPAP (N = 234). Therapeutic effectiveness (MDA as % change or as corrected change in AHI) was calculated as the product of therapeutic efficacy (% or absolute change in AHI) and adherence (% time on CPAP of average nightly sleep). Cardinality and propensity score matching was utilized to manage confounding variables. RESULTS: Surgery patients achieved greater MDA % than CPAP users (67 ± 30% vs. 60 ± 28%, p = 0.04, difference 7 ± 3%, 95% confidence interval 4% to 14%) in an unmatched comparison, despite a lower therapeutic efficacy seen with surgery. Cardinality matching demonstrated comparable MDA % in surgery (64%) and CPAP (57%) groups (p = 0.14, difference 8 ± 5%, 95% confidence interval -18% to 3%). MDA measured as corrected change in AHI showed similar results. CONCLUSIONS: In adult patients with OSA, multilevel upper airway surgery and CPAP provide comparable therapeutic effectiveness on polysomnography. For patients with inadequate CPAP use, surgery should be considered.

Low morbidity high anterior neck approach for removal of a deep intraglossal foreign body: A case report.

INTRODUCTION AND IMPORTANCE: In the era of both new bilateral hypoglossal nerve stimulator and long-standing experience with Sistrunk's procedures, it is notable that the literature scarcely describes high anterior neck approaches, tending to focus on transoral removal of intra-glossal foreign bodies. Herein we describe a case of a low morbidity anterior approach for access to an intra-glossal foreign body and discuss the implications. CASE PRESENTATION: A morbidly obese 73 year old lady presented acutely after inadvertent ingestion of a sewing needle. Initial assessment demonstrated an intraglossal foreign body which subsequently migrated into the deep substance of the tongue. Endoscopic retrieval was attempted but was unsuccessful. A midline transcervical anterior neck incision was made, exposure and midline separation of mylohyoid, and midline dissection of geniohyoid muscles was performed to expose genioglossi muscles and the foreign body removed. The patient recovered well without complication. CLINICAL DISCUSSION: This approach carries low morbidity compared to transoral approaches despite traditional dogma mandating avoidance of open neck approaches. Such approaches have recently been developed for implantation of bilateral hypoglossal nerve stimulators. CONCLUSION: Otolaryngologists should consider midline transcervical approach to retrieve deep intra-glossal foreign bodies, particularly in scenarios where other options may not provide adequate access or may enhance intra-oral morbidity.

Hypocalcaemia in pharyngolaryngectomy: Preservation or autotransplantation of parathyroid glands.

OBJECTIVE: To describe transient and permanent hypocalcaemia following partial and total pharyngolaryngectomy with parathyroid gland preservation or autotransplantation. METHODS: Thirty patients underwent partial or total pharyngolaryngectomy by a single surgeon during the period 2009-2020. Intraoperative parathyroid gland preservation or autotransplantation (where the gland appeared devascularized) was routinely performed. Calcium levels performed on day 1, 3 months, and at 12 months postoperatively were collected. Rates of transient and permanent hypocalcaemia were calculated. RESULTS: A total of 13% of patients had transient hypocalcaemia, and 10% permanent hypocalcaemia. Rates of transient and permanent hypocalcaemia in total pharyngolaryngectomy were 14% and 14%, respectively. Partial pharyngectomy hypocalcaemia rates were 13% for transient and 0% for permanent. The majority of patients underwent salvage surgery for oncological resection, often following radiotherapy (63%). Ipsilateral hemithyroidectomy was preferred to total (57% vs 7%), with high rates of concurrent neck dissection (67%) and reconstruction (87%). CONCLUSION: This data supports preservation or autotransplantation of parathyroid glands as a means of reducing permanent postoperative hypocalcaemia. LEVEL OF EVIDENCE: Level IV, case series, retrospective.

Modeling the upper airway: A precursor to personalized surgical interventions for the treatment of sleep apnea.

An accurate benchtop model was developed to mimic the different forms of human upper airway collapse in adult sleep apnea patients. This was done via modeling the airway through digital imaging. Airway representative models were then produced in two steps via a customized pneumatic extrusion 3D printing system. This allowed the pressure of collapse and planes of collapse to be manipulated to accurately represent those seen in sleep apnea patients. The pressure flow relationships of the collapsible airways were then studied by inserting the collapsible airways into a module that allowed the chamber pressure (Pc ) around the airways to be increased in order to cause collapse. Airways collapsed at physiologically relevant pressures (5.32-9.58 cmH2 O). Nickel and iron magnetic polymers were then printed into the airway in order to investigate the altering of the airway collapse. The introduction of the nickel and iron magnetic polymers increased the pressure of collapse substantially (7.38-17.51 cmH2 O). Finally, the force produced by the interaction of the magnetic polymer and the magnetic module was studied by measuring a sample of the magnetic airways. The peak force in (48.59-163.34 cN) and the distance over which the forces initially registered (6.8-9.7 mm) were measured using a force transducer. This data set may be used to inform future treatment of sleep apnea, specifically the production of an implantable polymer for surgical intervention.

An update on the current management of adult obstructive sleep apnoea.

BACKGROUND: Obstructive sleep apnoea (OSA) is common in adults. Various contributing factors to this condition have resulted in the development of a number of potential treatment modalities, some of which are in evolution. A multidisciplinary team involving the general practitioner is an important aspect in providing personalised care. OBJECTIVE: The aim of this review is to provide a clinical update on the recent developments and future directions in adult OSA management. DISCUSSION: In-lab polysomnography remains important in the diagnosis of OSA, although home sleep studies have good specificity and sensitivity in particular subgroups of patients. First-line therapy in adult OSA is continuous positive airway pressure, with mandibular advancement splints and surgical intervention considered second-line. Adjunctive therapies include weight loss, avoidance of supine sleep, management of nasal obstruction, alcohol intake limitation and exercise. Advancements in medications targeting multiple neurophysiological pathways, and surgical insertion of hypoglossal nerve stimulator devices represent possible future treatment pathways in Australia.

Sleep Apnea Multilevel Surgery (SAMS) trial protocol: a multicenter randomized clinical trial of upper airway surgery for patients with obstructive sleep apnea who have failed continuous positive airway pressure.

STUDY OBJECTIVES: Obstructive sleep apnea (OSA) is a serious and costly public health problem. The main medical treatment, continuous positive airway pressure, is efficacious when used, but poorly tolerated in up to 50% of patients. Upper airway reconstructive surgery is available when medical treatments fail but randomized trial evidence supporting its use is limited. This protocol details a randomized controlled trial designed to assess the clinical effectiveness, safety, and cost-effectiveness of a multilevel upper airway surgical procedure for OSA. METHODS: A prospective, parallel-group, open label, randomized, controlled, multicenter clinical trial in adults with moderate or severe OSA who have failed or refused medical therapies. Six clinical sites in Australia randomly allocated participants in a 1:1 ratio to receive either an upper airway surgical procedure consisting of a modified uvulopalatopharyngoplasty and minimally invasive tongue volume reduction, or to continue with ongoing medical management, and followed them for 6 months. RESULTS: Primary outcomes: difference between groups in baseline-adjusted 6 month OSA severity (apnea-hypopnea index) and subjective sleepiness (Epworth Sleepiness Scale). Secondary outcomes: other OSA symptoms (e.g. snoring and objective sleepiness), other polysomnography parameters (e.g. arousal index and 4% oxygen desaturation index), quality of life, 24 hr ambulatory blood pressure, adverse events, and adherence to ongoing medical therapies (medical group). CONCLUSIONS: The Sleep Apnea Multilevel Surgery (SAMS) trial is of global public health importance for testing the effectiveness and safety of a multilevel surgical procedure for patients with OSA who have failed medical treatment. CLINICAL TRIAL REGISTRATION: Multilevel airway surgery in patients with moderate-severe Obstructive Sleep Apnea (OSA) who have failed medical management to assess change in OSA events and daytime sleepiness. https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=366019&isReview=true Australian New Zealand Clinical Trials Registry ACTRN12614000338662, prospectively registered on 31 March 2014.

The need for a better prognostic staging system in patients with metastatic cutaneous squamous cell carcinoma of the head and neck.

PURPOSE OF REVIEW: A validated and universal staging system for metastatic cutaneous head and neck squamous cell carcinoma that accurately describes its clinical behaviour is vital for prognostication and management. The current clinical staging system is not specific for the head and neck and makes no allowances for disease extent. The lack of an improved staging system prevents any meaningful research into improved treatment strategies in patients with head and neck cutaneous squamous cell carcinoma. RECENT FINDINGS: Contemporary evidence supports surgery and adjuvant radiotherapy as current best practice for patients with operable metastatic head and neck cutaneous squamous cell carcinoma. Despite this, patients with poor-prognosis disease are still at risk of locoregional relapse and may benefit from collaborative research. The modified staging system proposed by O'Brien is an important aspect of any further research and is discussed in this article. SUMMARY: The present clinical staging for head and neck cutaneous squamous cell carcinoma is inadequate and the evidence to date supports a recommendation for changing the current system to reflect the heterogeneity and complexity of this disease.

Radiofrequency ablation of the lateral palatal space for snoring.

OBJECTIVE: Pilot study to examine the effect of radiofrequency ablation (RFA) of the lateral palatal fat pad in patients with socially-disruptive snoring. METHOD: Snoring outcomes and complications were compared between a group of patients with treated with RFA ablation of the lateral soft palate fat pad with or without inferior turbinate reduction (8 patients) and another group undergoing inferior turbinate reduction alone (12 patients). RESULTS: Snoring loudness and bothersomeness improved in the palate but not inferior turbinate group. Pain was mild and no major complications were observed. CONCLUSION: The study supports RFA ablation of the lateral palatal space as a potential low morbidity procedure for snoring.

Surgical Approaches to Obstructive Sleep Apnea.

Surgery in adult obstructive sleep apnea (OSA) has undergone significant advancement in recent years and continues to evolve. It is a modality of treatment used in the context of failed device use, specifically, failed continuous positive airway pressure or mandibular advancement splint. In this context, the role of surgery is either as salvage therapy or to facilitate better tolerance of device use. Other treatments such as weight loss, adjuvant nasal therapy (medical ± prephase nasal surgery) and positional devices may be combined with airway surgery. In general, patients with OSA are managed with in-hospital monitoring perioperatively.