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.

Stated patient preferences for overnight at-home diagnostic assessment of sleep disorders.

PURPOSE: The diagnostic workup for assessment of sleep disorders commonly involves overnight testing to assess sleep patterns and pathological events. So far, little is known about preferences for provision of home sleep tests to patients with sleep disorders. This study aims to close this gap by eliciting preferences for home sleep testing using a discrete choice experiment (DCE). METHODS: A DCE with seven attributes of at-home sleep testing and three levels per attribute was developed using a fractional factorial design. Patients with and without previous sleep testing experience were recruited from two large sleep centers in Germany. Coefficients for attribute levels were calculated using a conditional logit model to estimate their influence on choice decisions and calculate the relative importance of each attribute. RESULTS: 305 patients (54.5 ± 13,1 years, 65.3% male) were enrolled, and 288 surveys with complete data included for analysis. Attributes with greatest relevance were Waiting time to discuss sleep study results; Waiting time to conduct sleep study, and Sleep quality during measurement. Of lowest importance was Diagnostic accuracy of sleep study, followed by Effort to apply sleep study device. Significant heterogeneity in choice behavior was found, including differences by gender, willingness-to-pay for sleep studies, and previous experience with sleep studies. Preferred location for conducting sleep testing was at-home in 50.7% and in-lab in 46.9%. CONCLUSIONS: Preferences and relative importance of home sleep test attributes vary among different subgroups. Considering those preferences can be important for clinicians and policymakers when designing care pathways and planning of testing policies for sleep disorders.

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.

[Pathophysiology of obstructive sleep apnea]. / Pathophysiologie der obstruktiven Schlafapnoe.

The prevalence of obstructive sleep apnea (OSA) is considered to be very high in western industrialized countries. There are conservative and surgical forms of treatment for OSA; however, the pathophysiology is largely unexplained and cannot be explained by anatomical abnormalities alone. In recent years, a number of non-anatomical factors have been found that favor the development of OSA. These include the respiratory excitation threshold (arousals), the respiratory drive (loop gain), as well as the control and function of the muscular upper airway dilators. The understanding of the individual pathophysiological processes may be helpful in the future to develop individual treatment approaches for patients.

[The terminal hypoglossal nerve and its anatomical variability]. / Der terminale N. hypoglossus und seine anatomische Vielfalt.

Upper airway stimulation plays an increasingly important role in the treatment of obstructive sleep apnea (OSA). The target of stimulation is the hypoglossal nerve (N. XII), which-as a pure motor nerve-innervates the intrinsic and extrinsic tongue muscles. By selectively stimulating individual nerve fibers, the upper airway can be opened by protruding the tongue. The N. XII has a number of anatomical variants, which are decisive during surgical implantation of these pacemaker systems. Intraoperative neuromonitoring is very helpful in this regard. Accurate placement of the stimulation electrode for selective upper airway stimulation requires knowledge of N. XII anatomy, intraoperative neuromonitoring, and accurate assessment of muscle contractions and tongue movements.

[Sleep position trainers for treatment of supine obstructive sleep apnea : A comparison of two different training modalities]. / Schlafpositionstrainer zur Behandlung der rückenlagebezogenen obstruktiven Schlafapnoe : Vergleich von 2 verschiedenen Trainingsmodalitäten.

BACKGROUND: Many patients suffer from positional obstructive sleep apnea (POSA; 56%). In these cases, positional therapy may be an option. A sleep position trainer (SPT) is a small vibrating device that trains the patient to avoid sleeping in the supine position. This study aimed to compare the efficacy and tolerance of gradual and intensive training onset in POSA patients MATERIALS AND METHODS: Patients with mild to moderate POSA and incompliance with continuous positive airway pressure (CPAP) therapy were included in this prospective double-blind trail. Patients were randomized according to how training was initiated and the SPT was set to either a gradual or an intensive training program. Polygraphy was used to check respiratory parameters after 1 month, and subjective parameters and compliance were assessed prior to and after this time period using a questionnaire. RESULTS: A total of 38 patients were included (20 intensive; 18 gradual; 49 ± 13 years) of whom 31 completed the study protocol. After 1 month the apnea-hypopnea index (AHI) in both groups was significantly reduced, but there was no difference in AHI between the two training modalities (AHI intensive: 16.7 ± 6.3/h to 4.2 ± 3.2/h; AHI gradual: 18.9 ± 11.2/h to 8.4 ± 7.9/h). The same effect was observed for subjective sleepiness. CONCLUSION: The objective severity of OSA and the associated subjective daytime sleepiness was reduced in both groups. There was no difference in terms of clinical outcome or compliance between the gradual or intensive SPT therapy in POSA patients during the observation period. Both training modalities are highly successful and well tolerated.

[Sonographic evaluation of anatomic landmarks in patients with obstructive sleep apnea]. / Sonographische Evaluation anatomischer Landmarken bei Patienten mit obstruktiver Schlafapnoe.

BACKGROUND: In recent years, new key factors in the genesis of obstructive sleep apnea (OSA) have been described. This has led to investigation of individualized therapeutic approaches in sleep medicine. The aim of the current study is assessment of the upper respiratory tract by sonographic measurement of various anatomic landmarks. MATERIALS AND METHODS: Patients with rhonchopathy as well as OSA of different severity were included and compared to healthy volunteers. All patients underwent polygraphy for assessment of nocturnal respiratory disorders. Different landmarks were defined (extension of the tongue, thickness of the pharynx, hyoid bone-thyroid cartilage distance, extension of the geniohyoid muscle) which should be measured sonographically. RESULTS: A total of 155 patients were enrolled and assigned to one of five groups (control; rhonchopathy; mild, moderate, and severe OSA). There were significant differences in the parameters for measuring tongue size, the distance between the hyoid bone and thyroid cartilage, and the thickness of the pharynx between the groups. CONCLUSION: As part of this sonographic assessment of the upper respiratory tract, landmarks could be identified in patients with OSA that correlated with the severity of the disease.

[VOTE versus ACLTE: comparison of two snoring noise classifications using machine learning methods]. / VOTE versus ACLTE: Vergleich zweier Schnarchgeräuschklassifikationen mit Methoden des maschinellen Lernens.

BACKGROUND: Acoustic snoring sound analysis is a noninvasive method for diagnosis of the mechanical mechanisms causing snoring that can be performed during natural sleep. The objective of this work is development and evaluation of classification schemes for snoring sounds that can provide meaningful diagnostic support. MATERIALS AND METHODS: Based on two annotated snoring noise databases with different classifications (s-VOTE with four classes versus ACLTE with five classes), identically structured machine classification systems were trained. The feature extractor openSMILE was used in combination with a linear support vector machine for classification. RESULTS: With an unweighted average recall (UAR) of 55.4% for the s­VOTE model and 49.1% for the ACLTE, the results are at a similar level. In both models, the best differentiation is achieved for epiglottic snoring, while velar and oropharyngeal snoring are more often confused. CONCLUSION: Automated acoustic methods can help diagnose sleep-disordered breathing. A reason for the restricted recognition performance is the limited size of the training datasets.

Patient-reported outcome: results of the multicenter German post-market study.

PURPOSE: Upper airway stimulation (UAS) is an alternative second-line treatment option for patients with obstructive sleep apnea (OSA). In our substudy of a previous multicentre study of patients implanted with UAS, we focused on patient-related outcomes like Epworth Sleepiness Scale (ESS), the Functional Outcomes of Sleep Questionnaire (FOSQ), snoring and personal satisfaction 6 and 12 months after the implantation. METHODS: 60 patients, who were initially non-adherent to CPAP and implanted with UAS, were included in a prospective multicentre study. Data were collected preoperative, 6 and 12 months after implantation regarding FOSQ, ESS, snoring, and their experience with the UAS device. RESULTS: Besides relevant Apnoea-Hypopnea Index (AHI) reduction, we saw significant improvements in ESS (p < 0.001), FOSQ (p < 0.001) and snoring under UAS therapy. A strong correlation between AHI results postoperative and the personal satisfaction of the patients after implantation was found as well as between usage results and AHI compared to the preoperative results. CONCLUSION: The more the patients benefit from UAS according to their self-reported outcome, the higher is the therapy use.

[Stimulation for sleep apnea : Targeting the hypoglossal nerve in the treatment of patients with OSA]. / Stimulation bei Schlafapnoe : Stimulation des Nervus hypoglossus zur Behandlung der OSA.

Standard treatment of obstructive sleep apnea (OSA) is nightly application of positive airway pressure therapy (CPAP). However, adherence to CPAP is limited due to side effects and complications, and patients are frequently untreated or undertreated. In this scenario, patients with OSA are at risk of developing comorbidities such as arterial hypertension, coronary artery disease, or diabetes, and are exposed to an increased risk of experiencing traffic or occupational accidents due to daytime sleepiness. Alternative treatments include mandibular advancement devices or positional devices to prevent patients sleeping on their back, as well as anatomy-altering surgical procedures. For several years now, an additional surgical treatment-hypoglossal nerve stimulation-has been available for selected OSA patients. Hypoglossal nerve stimulation is a dynamic surgical approach that uses electrical stimulation to activate key muscles of the upper airway to achieve airway patency.

[Hypoglossal nerve stimulation in patients with CPAP failure : Evolution of an alternative treatment for patients with obstructive sleep apnea]. / Hypoglossusnervstimulation bei CPAP-Versagen : Evolution einer Alternativbehandlung für Patienten mit obstruktiver Schlafapnoe.

Obstructive sleep apnea (OSA) is a common disease in western industrialized countries with increasing prevalence. Gold standard of therapy is nocturnal positive pressure ventilation by continuous positive airway pressure (CPAP). Due to complications and side effects of ventilation, therapy adherence is limited. Recently an alternative surgical treatment has become available for these patients, which uses established techniques to stimulate the hypoglossus nerve to open the upper airway during sleep. The aim of this work is to provide an overview of the history and current state of scientific knowledge of this therapy in the treatment of OSA. Currently, two systems are available on the market: respiratory-driven hypoglossal nerve stimulation (Inspire Medical Systems) and continuous hypoglossal nerve stimulation (ImThera Medical). For respiratory-driven hypoglossal nerve stimulation, a solid body of evidence is available and the therapy has been investigated in numerous multicenter clinical studies with regard to safety and efficacy. Only a small number of publications is available for continuous hypoglossal nerve stimulation. At the end of the last century, promising clinical results were shown in the first patients treated with hypoglossal nerve stimulation. Consequent technological and scientific development of respiratory-driven hypoglossal nerve stimulation in recent years led to its implementation in today's clinical routine. This therapy significantly broadens the spectrum of therapies in the treatment of OSA, especially for patients with CPAP intolerance.

[Acoustic information in snoring noises]. / Akustische Informationen von Schnarchgeräuschen.

BACKGROUND: More than one third of all people snore regularly. Snoring is a common accompaniment of obstructive sleep apnea (OSA) and is often disruptive for the bed partner. OBJECTIVE: This work gives an overview of the history of and state of research on acoustic analysis of snoring for classification of OSA severity, detection of obstructive events, measurement of annoyance, and identification of the sound excitation location. MATERIALS AND METHODS: Based on these objectives, searches were conducted in the literature databases PubMed and IEEE Xplore. Publications dealing with the respective objectives according to title and abstract were selected from the search results. RESULTS: A total of 48 publications concerning the above objectives were considered. The limiting factor of many studies is the small number of subjects upon which the analyses are based. CONCLUSION: Recent research findings show promising results, such that acoustic analysis may find a place in the framework of sleep diagnostics, thus supplementing the recognized standard methods.

Functional outcome of tongue motions with selective hypoglossal nerve stimulation in patients with obstructive sleep apnea.

BACKGROUND: Selective upper airway stimulation of the hypoglossal nerve is a novel therapy option for obstructive sleep apnea. Different tongue motions were observed after surgery during active therapy. METHODS: We examined tongue motions in 14 patients (mean age 51 ± 10 years) who received an implantation of an upper airway stimulation system (Inspire Medical Systems) from September 2013 to February 2014 in three different implantation centers in Germany after surgery. Sleep recording was performed preoperatively: 2 months (M02) and 6 months (M06) after surgery. RESULTS: There were three different tongue motions observed after surgery at 1 month (M01), M02, and M06 after surgery: bilateral protrusion (BP), right protrusion (RP), and mixed activation (MA). At M01: 10 BP, 2 RP, and 2 MA; at M02: 12 BP, 0 RP, and 2 MA; and at M06: 12 BP, 0 RP, and 2 MA could be detected. The average apnea-hypopnea index (AHI) was reduced from 32.5 ± 14.2/h before surgery to 17.9 ± 23.3/h at M02 and 14.1 ± 19.8/h at M06. An increased reduction in AHI was found in BP and RP group (Baseline: 29.6 ± 12.6/h; M02: 12.06 ± 14.1/h; M06: 9.7 ± 12.6/h) compared to the MA group (Baseline 49.6 ± 13.8/h; M02: 49.7 ± 5.1/h; M06: 40.5 ± 4.1/h). CONCLUSIONS: These findings suggest that the postoperative tongue motions in upper airway stimulation are associated with the therapy outcome. The stimulation electrode placement on the hypoglossal nerve for selective muscle recruitment may play a role in the mechanism of action.

ENT-specific therapy of obstructive sleep apnoea in adults : A revised version of the previously published German S2e guideline.

The German Society of Otorhinolaryngology, Head and Neck Surgery recently has released the abbreviated version of its scientific guideline "ENT-specific therapy of obstructive sleep apnoea (OSA) in adults", which has been updated in 2015 and can be found online at the Association of the Scientific Medical Societies (Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften, AWMF). A summary of the main recommendations is provided in this revised English version. All recommendations are based on a systematic literature research of articles published up until March 2014. Literature research followed the Cochrane Handbook for Systematic Literature Research to create Guidelines published by the German Cochrane Centre. Studies were evaluated with respect to their scientific value according to the recommendations of the Oxford Centre for Evidence-based Medicine, and grades of recommendation are provided regarding each intervention.

[S2e-guideline: "ENT-specific therapy of obstructive sleep apnea in adults" short version : Sleep Medicine Task Force of the German Society for Otorhinolaryngology, Head and Neck Surgery]. / Leitlinie: "HNO-spezifische Therapie der obstruktiven Schlafapnoe bei Erwachsenen" Kurzfassung : ArGe Schlafmedizin der Deutschen Gesellschaft für Hals-Nasen-Ohren-Heilkunde, Kopf- und Hals-Chirurgie.

The present S2e-guideline is an update of the former S2e-guideline "treatment of obstructive sleep apnea in adults". The update was performed on behalf of the German Society for Otorhinolaryngology, Head and Neck Surgery by its Sleep Medicine Task Force. The long version of the guideline is valid from 5.9.2015 to 5.9.2020 and has been available (guideline No. 017-069) since November 2015 on the official AWMF website.The subsequently presented short version of the guideline summarizes the essentials in a legible way. For further information, please refer to the long version.

[Upper airway stimulation in obstructive sleep apnea]. / Stellungnahme der Taskforce "Neurostimulation bei Schlafapnoe" zur Stimulation der oberen Atemwege.

The stimulation of the upper airway represents an effective treatment option in case of CPAP failure in patients with moderate to severe obstructive sleep apnea. The stimulation with respiratory sensing (Inspire Medical Systems) has shown a high level of evidence in larger cohorts and longer follow-up studies. Whether the results of the stimulation without respiratory sensing (ImThera Medical) can be compared with the therapy with sensing, remains open up to now. Additional data are awaited after the planned phase III study THN#2. To optimize both procedure and to provide long term results, more studies are needed. The workgroup "sleep medicine" of the German Society of Oto-Rhino-Laryngology, Head and Neck Surgery supports theses activities with the help of the newly founded task force "Neurostimulation in Sleep Apnea".

[Sk2 guidelines"diagnosis and therapy of snoring in adults" : compiled by the sleep medicine working group of the German Society of Otorhinolaryngology, Head and Neck Surgery]. / S2k-Leitlinie "Diagnostik und Therapie des Schnarchens des Erwachsenen" : Vorgelegt von der Arbeitsgemeinschaft Schlafmedizin der Deutschen Gesellschaft für Hals-Nasen-Ohren-Heilkunde, Kopf- und Hals-Chirurgie e. V.

These guidelines aim to facilitate high quality medical care of adults with snoring problems. The guidelines were devised for application in both in- and outpatient environments and are directed primarily at all those concerned with the diagnosis and therapy of snoring. According to the AWMF three-level concept, these represent S2k guidelines.A satisfactory definition of snoring does not currently exist. Snoring is the result of vibration of soft tissue structures in narrow regions of the upper airway during breathing while asleep. Ultimately, these vibrations are caused by the sleep-associated decrease in muscle tone in the area of the upper airway dilator muscles. A multitude of risk factors for snoring have been described and its occurrence is multifactorial. Data relating to the frequency of snoring vary widely, depending on the way in which the data are collected. Snoring is usually observed in middle-aged individuals and affected males predominate. Clinical diagnosis of snoring should comprise a free evaluation of the patient's medical history. Where possible this should also involve their bed partner and the case history can be complimented by questionnaires. To determine the airflow relevant structures, a clinical examination of the nose should be performed. This examination may also include nasal endoscopy. Examination of the oropharynx is particularly important and should be performed. The larynx and the hypopharynx should be examined. The size of the tongue and the condition of the mucous membranes should be recorded as part of the oral cavity examination, as should the results of a dental assessment. Facial skeleton morphology should be assessed for orientation purposes. Technical examinations may be advisable in individual cases. In the instance of suspected sleep-related breathing disorders, relevant comorbidities or where treatment for snoring has been requested, an objective sleep medicine examination should be performed. Snoring is not-at least as we currently understand it-a disease associated with a medical threat; therefore there is currently no medical necessity to treat the condition. All overweight patients with snoring problems should strive to lose weight. If snoring is associated with the supine position, positional therapy can be considered. Some cases of snoring can be appropriately treated using an intraoral device. Selected minimally invasive surgical procedures on the soft palate can be recommended to treat snoring, provided that examinations have revealed a suitable anatomy. The choice of technique is determined primarily by the individual anatomy. At an appropriate interval after the commencement or completion a therapeutic measure, a follow-up examination should be conducted to assess the success of the therapy and to aid in the planning of any further treatments.

Palatal implants in the treatment of obstructive sleep apnea: a randomised, placebo-controlled single-centre trial.

Palatal implants have been used to treat snoring and mild to moderate obstructive sleep apnea (OSA). Two previous controlled trials have published conflicting results regarding the effects of palatal implants on objective outcome measures, although they both could demonstrate superiority over placebo. The aim of the present study was to assess the effects of palatal implants in patients with mild to moderate sleep apnea in a randomised, placebo-controlled trial. Twenty-two patients with mild to moderate OSA (AHI 18 ± 5, BMI 28 ± 3, age 51 ± 13 years) due to palatal obstruction were enrolled in this randomised, double-blind, placebo-controlled trial. Respiratory parameters and sleep efficiency (evaluated by polysomnography), snoring (evaluated by the bed partner), and daytime sleepiness (evaluated by ESS) were assessed before and 90 days after surgery. One patient in each group did not show up for follow-up. The AHI, HI and LSAT showed statistically significant improvement in the treatment group (p < 0.05). Snoring as rated by bed partners also showed statistically significant improvement within the treatment group (p = 0.025). There was no statistical difference when comparing the means of the treatment group with the placebo group. There were no peri- or post-operative complications and no extrusions during the follow-up period. The study supports the idea that palatal implants lead to a reduction in respiratory events in patients with mild to moderate OSA, although a statistically significant superiority of palatal implants over placebo could not be demonstrated in this trial.