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Sleep Apnea Syndromes: HELP
Articles by Joachim Theodor Maurer
Based on 40 articles published since 2008
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Between 2008 and 2019, J. Maurer wrote the following 40 articles about Sleep Apnea Syndromes.
 
+ Citations + Abstracts
Pages: 1 · 2
1 Guideline ENT-specific therapy of obstructive sleep apnoea in adults : A revised version of the previously published German S2e guideline. 2016

Verse, T / Dreher, A / Heiser, C / Herzog, M / Maurer, J T / Pirsig, W / Rohde, K / Rothmeier, N / Sauter, A / Steffen, A / Wenzel, S / Stuck, B A. ·Department of Otorhinolaryngology, Head and Neck Surgery, Asklepios Klinikum Harburg, Eißendorfer Pferdeweg 52, 21075, Hamburg, Germany. · Klinik für Hals-Nasen-Ohrenheilkunde, Kopf- und Halschirurgie der Ludwig-Maximilians-Universität München, Munich, Germany. · Department of Otorhinolaryngology, Head and Neck Surgery, Technische Universität München, Munich, Germany. · Department of Otorhinolaryngology, Head and Neck Surgery, Carl-Thiem-Klinikum, Thiemstr. 111, 03048, Cottbus, Germany. · Sleep Disorders Center, Department of Otorhinolaryngology, Head and Neck Surgery, University Hospital Mannheim, 68135, Mannheim, Germany. · , Mozartstr. 22/1, 89075, Ulm, Germany. · HNO-Praxis an der Oper, Dammtorstr. 27, 20354, Hamburg, Germany. · HNO-Gemeinschaftspraxis, Ebertstr. 20, 45879, Gelsenkirchen, Germany. · HNO Praxis Moser, Gehrking und Partner, Ludwigstr. 7, 86150, Augsburg, Germany. · Universitätsklinikum Schleswig-Holstein, Campus Lübeck, Klinik für HNO-Heilkunde, Ratzeburger Alle 160, 23562, Lübeck, Germany. · Sleep Disorders Center, Department of Otorhinolaryngology, Head and Neck Surgery, University Hospital Mannheim, 68135, Mannheim, Germany. boris.stuck@uk-essen.de. · Department of Otorhinolaryngology, Head and Neck Surgery, University Hospital Essen, Hufelandstr. 55, 45147, Essen, Germany. boris.stuck@uk-essen.de. ·Sleep Breath · Pubmed #27179662.

ABSTRACT: 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.

2 Guideline Diagnosis and treatment of snoring in adults-S2k Guideline of the German Society of Otorhinolaryngology, Head and Neck Surgery. 2015

Stuck, Boris A / Dreher, Alfred / Heiser, Clemens / Herzog, Michael / Kühnel, Thomas / Maurer, Joachim T / Pistner, Hans / Sitter, Helmut / Steffen, Armin / Verse, Thomas. ·Department of Otorhinolaryngology, Head and Neck Surgery, University Hospital Mannheim, Theodor-Kutzer-Ufer 1-3, 68167, Mannheim, Germany, boris.stuck@umm.de. ·Sleep Breath · Pubmed #24729153.

ABSTRACT: OBJECTIVES: This guideline aims to promote high-quality care by medical specialists for subjects who snore and is designed for everyone involved in the diagnosis and treatment of snoring in an in- or outpatient setting. DISCUSSION: To date, a satisfactory definition of snoring is lacking. Snoring is caused by a vibration of soft tissue in the upper airway induced by respiration during sleep. It is triggered by relaxation of the upper airway dilator muscles that occurs during sleep. Multiple risk factors for snoring have been described and snoring is of multifactorial origin. The true incidence of snoring is not clear to date, as the incidence differs throughout literature. Snoring is more likely to appear in middle age, predominantly in males. Diagnostic measures should include a sleep medical history, preferably involving an interview with the bed partner, and may be completed with questionnaires. Clinical examination should include examination of the nose to evaluate the relevant structures for nasal breathing and may be completed with nasal endoscopy. Evaluation of the oropharynx, larynx, and hypopharynx should also be performed. Clinical assessment of the oral cavity should include the size of the tongue, the mucosa of the oral cavity, and the dental status. Furthermore, facial skeletal morphology should be evaluated. In select cases, technical diagnostic measures may be added. Further objective measures should be performed if the medical history and/or clinical examination suggest sleep-disordered breathing, if relevant comorbidities are present, and if the subject requests treatment for snoring. According to current knowledge, snoring is not associated with medical hazard, and generally, there is no medical indication for treatment. Weight reduction should be achieved in every overweight subject who snores. In snorers who snore only in the supine position, positional treatment can be considered. In suitable cases, snoring can be treated successfully with intraoral devices. Minimally invasive surgery of the soft palate can be considered as long as the individual anatomy appears suitable. Treatment selection should be based on individual anatomic findings. After a therapeutic intervention, follow-up visits should take place after an appropriate time frame to assess treatment success and to potentially indicate further intervention.

3 Guideline Non-CPAP therapies in obstructive sleep apnoea. 2011

Randerath, W J / Verbraecken, J / Andreas, S / Bettega, G / Boudewyns, A / Hamans, E / Jalbert, F / Paoli, J R / Sanner, B / Smith, I / Stuck, B A / Lacassagne, L / Marklund, M / Maurer, J T / Pepin, J L / Valipour, A / Verse, T / Fietze, I / Anonymous2140689. ·Institute for Pneumology at the University Witten/Herdecke,Clinic for Pneumology and Allergology, Centre of Sleep Medicine and Respiratory Care, Bethanien Hospital, Solingen, Germany. randerath@klinik-bethanien.de ·Eur Respir J · Pubmed #21406515.

ABSTRACT: In view of the high prevalence and the relevant impairment of patients with obstructive sleep apnoea syndrome (OSAS) lots of methods are offered which promise definitive cures for or relevant improvement of OSAS. This report summarises the efficacy of alternative treatment options in OSAS. An interdisciplinary European Respiratory Society task force evaluated the scientific literature according to the standards of evidence-based medicine. Evidence supports the use of mandibular advancement devices in mild to moderate OSAS. Maxillomandibular osteotomy seems to be as efficient as continuous positive airway pressure (CPAP) in patients who refuse conservative treatment. Distraction osteogenesis is usefully applied in congenital micrognathia or midface hypoplasia. There is a trend towards improvment after weight reduction. Positional therapy is clearly inferior to CPAP and long-term compliance is poor. Drugs, nasal dilators and apnoea triggered muscle stimulation cannot be recommended as effective treatments of OSAS at the moment. Nasal surgery, radiofrequency tonsil reduction, tongue base surgery, uvulopalatal flap, laser midline glossectomy, tongue suspension and genioglossus advancement cannot be recommended as single interventions. Uvulopalatopharyngoplasty, pillar implants and hyoid suspension should only be considered in selected patients and potential benefits should be weighed against the risk of long-term side-effects. Multilevel surgery is only a salvage procedure for OSA patients.

4 Guideline [Guideline: Treatment of obstructive sleep apnea in adults]. 2009

Verse, T / Bodlaj, R / de la Chaux, R / Dreher, A / Heiser, C / Herzog, M / Hohenhorst, W / Hörmann, K / Kaschke, O / Kühnel, T / Mahl, N / Maurer, J T / Pirsig, W / Rohde, K / Sauter, A / Schedler, M / Siegert, R / Steffen, A / Stuck, B A / Anonymous2900641. ·Abteilung für HNO-Heilkunde, Kopf- und Halschirurgie, Asklepios-Klinik Harburg, 21075 Hamburg. t.verse@asklepios.com ·HNO · Pubmed #19855948.

ABSTRACT: The current guideline discusses conservative and surgical therapy of obstructive sleep apnea (OSA) in adults from the perspective of the ear, nose and throat specialist. The revised guideline was commissioned by the German Society of Ear-Nose-Throat, Head-Neck Surgery (DG HNO KHC) and compiled by the DG HNO KHC's Working Group on Sleep Medicine. The guideline was based on a formal consensus procedure according to the guidelines set out by the German Association of Scientific Medical Societies (AWMF) in the form of a"S2e guideline". Research of the literature available on the subject up to and including December 2008 forms the basis for the recommendations. Evaluation of the publications found was made according to the recommendations of the Oxford Centre for Evidence-Based Medicine (OCEBM). This yielded a recommendation grade, whereby grade A represents highly evidence-based studies and grade D those with a low evidence base.

5 Editorial Improving surgical therapy for sleep-disordered breathing by controlled trials. 2013

Maurer, Joachim T. · ·Sleep Breath · Pubmed #22760815.

ABSTRACT: -- No abstract --

6 Editorial Etiology of obstructive sleep apnea--the number of nerve fibers at the base of the uvula seems important. 2012

Maurer, Joachim T. · ·Sleep Breath · Pubmed #21948043.

ABSTRACT: -- No abstract --

7 Editorial Analyzing strange sounds during night. 2011

Maurer, Joachim T. · ·Sleep Breath · Pubmed #20862556.

ABSTRACT: -- No abstract --

8 Review [Drug-induced sedation endoscopy-quo vadis? : Review and outlook]. 2017

Herzog, M / Maurer, J T. ·Klinik für HNO-Krankheiten, Kopf- und Halschirurgie, Carl-Thiem-Klinikum, Thiemstr. 111, 03048, Cottbus, Deutschland. m.herzog@ctk.de. · Schlafmedizinisches Zentrum, Universitäts-HNO-Klinik Mannheim, Mannheim, Deutschland. ·HNO · Pubmed #28116457.

ABSTRACT: BACKGROUND: Drug-induced sedation endoscopy (DISE) is a diagnostic procedure which allows evaluation of the collapsibility of the upper airway. According to expert opinion, it is possible to imitate nocturnal collapsibility and perform a realistic investigation of the site of obstruction and vibration. This should enable sufficient and precise therapeutic advice to be given solely on the basis of clinical assessment. OBJECTIVE: The current publication critically evaluates the present state of development of DISE and its potential indications. MATERIALS AND METHODS: A PubMed literature research was performed using "sleep" and "endoscopy" or "DISE" as keywords. Relevant publications were evaluated. RESULTS: The present publication provides a historical summary of the available publications and relates these to other methods for examining obstructive sleep apnea. The present state of DISE in terms of drugs applied, grading systems, and validity is evaluated. Indications for DISE are described and critically discussed on the basis of literature data. CONCLUSION: DISE provides deep insights into the genesis of obstructions of the upper airway and snoring. Although its value for diagnosis and treatment of sleep-disordered breathing could not yet be demonstrated for all non-CPAP (continuous positive airway pressure) therapies, DISE could identify predictive parameters some methods. Further potential indications for DISE might be predictive examinations for mandibular advancement devices and respiration-synchronous neurostimulation of the hypoglossal nerve. DISE will thus remain a valuable diagnostic tool for obstructive sleep apnea and rhonchopathy.

9 Review Recent developments in the diagnosis and treatment of obstructive sleep apnea : English version. 2017

Stuck, B A / Maurer, J T. ·Department of Otorhinolaryngology, Head and Neck Surgery, Essen University Hospital, Hufelandstraße 55, 45147, Essen, Germany. boris.stuck@uk-essen.de. · Sleep Disorders Centre, Department of Otorhinolaryngology, Head and Neck Surgery, University Hospital Mannheim, Mannheim, Germany. boris.stuck@uk-essen.de. · Sleep Disorders Centre, Department of Otorhinolaryngology, Head and Neck Surgery, University Hospital Mannheim, Mannheim, Germany. ·HNO · Pubmed #27299890.

ABSTRACT: Over the past few years, the diagnostic tools and therapeutic approaches for obstructive sleep apnea (OSA) have evolved further. Based on a review of the current literature and the personal experiences of the authors, the most relevant developments are summarized in this article and discussed with regard to their impact on the clinical management of the disease. In the third edition of the International Classification of Sleep Disorders, the classification of sleep-disordered breathing was modified. Notably, additional clinical criteria for the diagnosis of OSA were established and out-of-center sleep testing was introduced as an alternative to polysomnography. Recent technical advancements in diagnostic tools (e. g., peripheral arterial tonometry and pulse wave analysis) have further expanded the diagnostic possibilities. Drug-induced sleep endoscopy allows for a reliable assessment of the level and degree of upper airway obstruction. Whether this gain in diagnostic information leads to an improvement in surgical outcome is, however, still being discussed. The relevance of positional OSA has received increasing attention - the subgroup of patients in whom sleeping position significantly impacts their disease is reported to be above 50 %. For these patients, the introduction of the sleep position trainer offers a new therapeutic option. Further, hypoglossal nerve stimulation (upper airway stimulation) has substantially expanded the surgical spectrum for the treatment of OSA. In regard to the established surgical treatment options, randomized trials with superior methodology have been published, especially for bimaxillary advancement and tonsillectomy with uvulopalatopharyngoplasty. These developments are of particular interest for the otolaryngologist and will influence daily practice.

10 Review [Recent developments in the diagnosis and treatment of obstructive sleep apnea]. 2016

Stuck, B A / Maurer, J T. ·Klinik für Hals-Nasen-Ohren-Heilkunde, Kopf- und Hals-Chirurgie, Universitätsklinikum Essen, Hufelandstraße 55, 45147, Essen, Deutschland. boris.stuck@uk-essen.de. · Schlafmedizinisches Zentrum, Universitäts-HNO-Klinik Mannheim, Universitätsmedizin Mannheim, Mannheim, Deutschland. boris.stuck@uk-essen.de. · Schlafmedizinisches Zentrum, Universitäts-HNO-Klinik Mannheim, Universitätsmedizin Mannheim, Mannheim, Deutschland. ·HNO · Pubmed #26666555.

ABSTRACT: Over the past years, the diagnostic tools and therapeutic approaches for obstructive sleep apnea (OSA) have further evolved. Based on a review of current literature and the personal experiences of the authors, the most relevant developments are summarized in this article and discussed with regard to their impact on the clinical management of this disease. In the third edition of the "International Classification of Sleep Disorders", the classification of sleep-disordered breathing was modified. Notably, additional clinical criteria for the diagnosis of OSA were established and out-of-center sleep testing was introduced as an alternative to polysomnography. Recent technical advancement of new diagnostic tools (e.g., peripheral arterial tonometry and pulse wave analysis) has further expanded the diagnostic possibilities. Drug-induced sleep endoscopy enables reliable assessment of the level and degree of upper airway obstruction. Whether this gain in diagnostic information leads to an improvement in surgical outcome is, however, still under discussion. The relevance of positional OSA has received increasing attention-the proportion of patients in whom sleeping position significantly impacts disease is reported to be above 50%. For these patients, the introduction of the sleep position trainer has made a new therapeutic option available. Furthermore, hypoglossal nerve stimulation (upper airway stimulation) has substantially expanded the surgical spectrum of OSA treatment. For the established surgical treatment options, randomized trials with superior methodology have been published, particularly for bimaxillary advancement and tonsillectomy with uvulopalatopharyngoplasty. These developments are of particular interest for the otolaryngologist and will influence daily practice.

11 Review [Upper airway stimulation in obstructive sleep apnea]. 2015

Steffen, A / Heiser, C / Herzog, M / Bergler, W / Rothmeier, N / Maurer, J T. ·HNO-Klinik, Universität zu Lübeck, Lübeck. · Hals-Nasen-Ohren-Klinik und Poliklinik, Klinikum rechts der Isar der Technischen Universität München, München. · Universitätsklinik und Poliklinik für Hals-Nasen-Ohren-Heilkunde, Kopf- und Hals-Chirurgie, Halle (Saale), Universitätsklinikum Halle (Saale). · Hals-Nasen-Ohren-Klinik, St. Joseph-Stift, Bremen. · Klinik für Hals-Nasen-Ohren-Heilkunde, Kopf- und Hals-Chirurgie, Universitätsklinikum Essen, Essen. · Universitäts-HNO-Klinik, Universitätsmedizin Mannheim, Mannheim. ·Laryngorhinootologie · Pubmed #25837366.

ABSTRACT: 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".

12 Review Surgical treatment of obstructive sleep apnea: standard and emerging techniques. 2010

Maurer, Joachim T. ·Department of Otorhinolaryngology, Sleep Disorders Center, University Medicine Mannheim, Medical Faculty Mannheim of the Ruprecht-Karls-University Heidelberg, Mannheim, Germany. Joachim.maurer@umm.de ·Curr Opin Pulm Med · Pubmed #20842037.

ABSTRACT: PURPOSE OF REVIEW: Patients with obstructive sleep apnea (OSA), as well as their physicians, seek alternative therapies to continuous positive airway pressure (CPAP) due to problems with CPAP adherence. A large variety of surgical options exist, and each intervention must be individually evaluated. The author performed a literature search concerning surgery for sleep apnea until May 2010. The studies were evaluated according to evidence-based medicine criteria. RECENT FINDINGS: An increasing number of controlled and even randomized controlled trials are available. Minimally invasive surgery remains under debate due to the very limited efficacy versus very low morbidity. Uvulopalatopharyngoplasty is still the standard procedure for many patients with moderate OSA, whereas maxillomandibular advancement is as effective as CPAP in severe OSA. Multilevel surgery is reserved to secondary treatment after CPAP failure. Tonsillectomy and maxillomandibular advancement may be offered as a first-line treatment in certain patients. There is increasing evidence that upper airway surgery has a positive impact on arterial hypertension, markers of cardiovascular disease, insomnia, daytime symptoms, quality of life, and CPAP adherence. SUMMARY: Patients who are nonadherent to CPAP must be thoroughly evaluated before choosing any of the available surgical options. Upper airway surgery may improve disease markers of OSA, if appropriately chosen and properly indicated and performed.

13 Review Update on surgical treatments for sleep apnea. 2009

Maurer, Joachim T. ·Department of Otorhinolaryngology, Sleep Disorders Centre, University Medicine Mannheim, Medical Faculty Mannheim of the Ruprecht-Karls-University Heidelberg, Mannheim, Germany. Joachim.maurer@hno.ma.uni-heidelberg.de ·Swiss Med Wkly · Pubmed #19950024.

ABSTRACT: Many patients with obstructive sleep apnoea (OSA), as well as the medical community, are seeking alternative therapies to continuous positive airway pressure (CPAP). Where there are problems with CPAP adherence, surgical procedures are an option without the need for adequate compliance. A wide variety of surgical procedures is available, all of which address the differing anatomy and types of patients requiring specific evaluation of the available data. The author performed a literature search up to October 2008, the studies being evaluated according to EBM criteria. The data for some of the methods was limited. Minimally invasive surgery is helpful due to its positive efficacy vs morbidity ratio. While UPPP is still the standard procedure in mild to moderate OSA, its success is difficult to predict and often falls off with the passage of years. Additional upper airway investigations have not yet succeeded in overcoming this disadvantage. Combined surgery of the multi-level is reserved for secondary treatment after CPAP failure. Only tonsillectomy and maxillomandibular advancement are successful enough to be considered a first-line treatment in certain patients.

14 Review [Update on upper airway evaluation in obstructive sleep apnea]. 2008

Maurer, J T / Stuck, B A. ·Schlafmedizinisches Zentrum, Universitäts-Hals-Nasen-Ohren-Klinik Mannheim, Medizinische Fakultät Mannheim der Ruprecht-Karls-Universität Heidelberg, 68135 Mannheim, Deutschland. Joachim.Maurer@hno.ma.uni-heidelberg.de ·HNO · Pubmed #18853128.

ABSTRACT: During the past two decades, different methods of upper airway evaluation for patients with obstructive sleep apnea (OSA) have been investigated. Although clinical assessment is the basis of any diagnostic workflow in OSA, the Mueller maneuver is apparently of no importance. Imaging techniques have increased our knowledge of the pathophysiology of OSA. Cephalometry is done only if maxillomandibular advancement is planned; dynamic investigations such as computed tomography and magnetic resonance imaging are able to picture the pharyngeal collapse and have the capacity to simulate the effect of interventions on OSA severity. So far, video endoscopy under sedation can only predict the success of oral appliances. Multichannel pressure recordings depict the distribution of obstructive events in the upper or lower pharyngeal segment during the entire night. The impact of sophisticated upper airway evaluation remains limited compared with standard clinical assessment. Further research is needed to develop valuable tools for the diagnostic workup of patients with OSA.

15 Review [Early detection of sleep associated breathing disorders]. 2008

Maurer, J T. ·Schlafmedizinisches Zentrum, Universitäts-Hals-Nasen-Ohrenklinik Mannheim, Medizinische Fakultät Mannheim der Ruprecht-Karls-Universität Heidelberg. Joachim.Maurer@hno.ma.uni-heidelberg.de ·Laryngorhinootologie · Pubmed #18373308.

ABSTRACT: -- No abstract --

16 Guideline European position paper on drug-induced sedation endoscopy (DISE). 2014

De Vito, Andrea / Carrasco Llatas, Marina / Vanni, Agnoletti / Bosi, Marcello / Braghiroli, Alberto / Campanini, Aldo / de Vries, Nico / Hamans, Evert / Hohenhorst, Winfried / Kotecha, Bhik T / Maurer, Joachim / Montevecchi, Filippo / Piccin, Ottavio / Sorrenti, Giovanni / Vanderveken, Olivier M / Vicini, Claudio. ·Special Surgery Department, Ear-Nose-Throat Unit, Morgagni-Pierantoni Hospital, Via Forlanini 34, 47121, Forlì, Italy. ·Sleep Breath · Pubmed #24859484.

ABSTRACT: BACKGROUND: Although drug-induced sedation endoscopy (DISE) represents the most widespread diagnostic tool for upper airway endoscopic evaluation of snoring and obstructive sleep apnea hypopnea syndrome (OSAHS), many controversies exist about how to perform the sedation, the indications for DISE, and how to report DISE findings. The present position paper reports on a consensus as proposed by a group of European experts in the field of DISE after discussion during a recent dedicated meeting. METHODS: The authors have evaluated all the available evidence reported in the literature and have compared experience among various departments in leading European centers in order to provide a standardization of the DISE procedure and an in-depth insight in the main aspects of this technique. RESULTS: A proposal of the DISE procedure standardization has been achieved with a general agreement concerning the terminology, indications, contraindications, required preliminary examinations, setting, technical equipment required, staffing, local anesthesia and nasal decongestion, patient positioning, basis and special diagnostic maneuvers, and the applied sedation drugs and observation windows. Otherwise, no consensus has been reached on a scoring and classification system. CONCLUSIONS: Although consensus has been reached on several aspects of the DISE procedure, some topics remain open to future research, such as a better analysis of the importance of positional aspects during DISE and a further comparison of the differences in degree, level and pattern of upper airway collapse observed during DISE versus during natural sleep and awake endoscopy. Finally, a universally accepted scoring and classification system is lacking.

17 Clinical Trial Patient-reported outcome: results of the multicenter German post-market study. 2018

Hasselbacher, Katrin / Hofauer, B / Maurer, J T / Heiser, C / Steffen, A / Sommer, J U. ·Department of Otorhinolaryngology, University of Lübeck, Ratzeburger Allee, 23538, Lübeck, Germany. Katrin.Hasselbacher@uksh.de. · Department of Otorhinolaryngology, Head and Neck Surgery, Klinikum rechts der Isar, Munich, Germany. · Department of Otorhinolaryngology, Head and Neck Surgery, University-Hospital Mannheim, Mannheim, Germany. · Department of Otorhinolaryngology, University of Lübeck, Ratzeburger Allee, 23538, Lübeck, Germany. ·Eur Arch Otorhinolaryngol · Pubmed #29808422.

ABSTRACT: 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.

18 Clinical Trial Outcome after one year of upper airway stimulation for obstructive sleep apnea in a multicenter German post-market study. 2018

Steffen, Armin / Sommer, J Ulrich / Hofauer, Benedikt / Maurer, Joachim T / Hasselbacher, Katrin / Heiser, Clemens. ·Department of Otorhinolaryngology, University of Lübeck, Lübeck, Germany. · Department of Otorhinolaryngology, Head and Neck Surgery, University-Hospital Mannheim, Mannheim, Germany. · Department of Otorhinolaryngology, Head and Neck Surgery, Klinikum rechts der Isar, Munich, Germany. ·Laryngoscope · Pubmed #28561345.

ABSTRACT: OBJECTIVE/HYPOTHESIS: Upper airway stimulation (UAS) of the hypoglossal nerve has been implemented in the routine clinical practice for patients with moderate-to-severe obstructive sleep apnea (OSA) who could not adhere to continuous positive airway pressure. This study reports objective and patient-reported outcome after 12 months of implantation. STUDY DESIGN: Multicenter prospective single-arm study. METHODS: Consecutive patients who received the UAS system (Inspire Medical Systems, Inc., Minneapolis, Minnesota, Maple Grove, MN, U.S.A.) were enrolled in three German centers. Key study exclusion criteria included body mass index > 35 kg/m RESULTS: Among the total of 60 participants, the median AHI reduced from 28.6 to 9.5 from baseline to 12 months. Patient-reported outcome measured in Epworth Sleepiness Scale and Functional Outcomes of Sleep Questionnaire both improved significantly from baseline to 12 months. The average usage time was 39.1 ± 14.9 hours per week among all participants based on recordings by the implanted device. One patient requested a removal of the device for cosmetic and other personal reasons and was completed without sequelae. CONCLUSION: This study supported that UAS is a safe and effective treatment option for patients with OSA in routine clinical practice. LEVEL OF EVIDENCE: 4. Laryngoscope, 128:509-515, 2018.

19 Clinical Trial Outcomes of Upper Airway Stimulation for Obstructive Sleep Apnea in a Multicenter German Postmarket Study. 2017

Heiser, Clemens / Maurer, Joachim T / Hofauer, Benedikt / Sommer, J Ulrich / Seitz, Annemarie / Steffen, Armin. ·1 Department of Otorhinolaryngology-Head and Neck Surgery, Klinikum rechts der Isar, Technische Universität München, Munich, Germany. · 2 Department of Otorhinolaryngology-Head and Neck Surgery, University-Hospital Mannheim, Mannheim, Germany. · 3 Department of Otorhinolaryngology, University of Lübeck, Lübeck, Germany. ·Otolaryngol Head Neck Surg · Pubmed #28025918.

ABSTRACT: Objective Selective stimulation of the hypoglossal nerve is a new surgical therapy for obstructive sleep apnea, with proven efficacy in well-designed clinical trials. The aim of the study is to obtain additional safety and efficacy data on the use of selective upper airway stimulation during daily clinical routine. Study Design Prospective single-arm study. Setting Three tertiary hospitals in Germany (Munich, Mannheim, Lübeck). Subjects and Methods A multicenter prospective single-arm study under a common implant and follow-up protocol took place in 3 German centers (Mannheim, Munich, Lübeck). Every patient who received an implant of selective upper airway stimulation was included in this trial (apnea-hypopnea index ≥15/h and ≤65/h and body mass index <35 kg/m

20 Clinical Trial Targeted hypoglossal nerve stimulation for the treatment of obstructive sleep apnea: Six-month results. 2016

Friedman, Michael / Jacobowitz, Ofer / Hwang, Michelle S / Bergler, Wolfgang / Fietze, Ingo / Rombaux, Philippe / Mwenge, Gimbada B / Yalamanchali, Sreeya / Campana, John / Maurer, Joachim T. ·Rush University Medical Center and Advanced Center for Specialty Care, Advocate Illinois Masonic Medical Center, Chicago, Illinois, U.S.A.. mfriedman@chicagoent.com. · ENT and Allergy Associates, Orange Regional Medical Center, Middletown, New York, U.S.A. · Rush University Medical Center and Advanced Center for Specialty Care, Advocate Illinois Masonic Medical Center, Chicago, Illinois, U.S.A. · Head and Neck Department, St. Joseph Hospital, Bremen, Germany. · Department of Cardiology, Center of Sleep Medicine, Charité-Universitätsmedizin Berlin, Berlin, Germany. · Saint Luc University Clinics, Department of Oto-Rhino-Laryngology, Institute of Neurosciences, University of Louvain, Brussels, Belgium. · Colorado Head and Neck Specialists, Denver, Colorado, U.S.A. · Mannheim University ENT Clinic, Mannheim, Germany. ·Laryngoscope · Pubmed #27010361.

ABSTRACT: OBJECTIVES/HYPOTHESIS: This feasibility study was designed to show the preliminary safety and efficacy of targeted hypoglossal neurostimulation (THN), and to identify baseline predictors of successful therapy. STUDY DESIGN: Open-label, prospective, multicenter, single-arm cohort study, conducted at seven centers in the U.S.A. and Europe. METHODS: Forty-six participants with moderate to severe obstructive sleep apnea (OSA), failing or intolerant of continuous positive airway pressure, were implanted. Primary (Apnea-Hypopnea Index [AHI], Oxygen Desaturation Index [ODI]) and secondary (Arousal Index, Epworth Sleepiness Scale Index, Sleep Apnea Quality of Life Index) outcomes were measured at baseline and compared at 6 months. Data were analyzed to identify participant characteristics that would predict success with therapy. RESULTS: Sixty-seven adverse events (AEs) were observed among 36 participants; most of the AEs were related to the implant procedure and resolved without sequelae; one device replacement was necessary. Forty-three participants showed significant (P < .01) decreases in both AHI and ODI at 6 months; 35% (15 of 43) met criteria for AHI responders and 40% (17 of 43) for ODI responders. Significant improvement was observed in all the secondary endpoints. Predictors-of-success selection criteria were identified as baseline AHI < 65/hr, baseline apnea index ≤ 30, baseline body mass index < 35, and <15 events/hr of SpO CONCLUSIONS: This feasibility study suggests that THN therapy is likely to be safe and effective in selected patients. LEVEL OF EVIDENCE: 2b Laryngoscope, 126:2618-2623, 2016.

21 Clinical Trial Three-Year Outcomes of Cranial Nerve Stimulation for Obstructive Sleep Apnea: The STAR Trial. 2016

Woodson, B Tucker / Soose, Ryan J / Gillespie, M Boyd / Strohl, Kingman P / Maurer, Joachim T / de Vries, Nico / Steward, David L / Baskin, Jonathan Z / Badr, M Safwan / Lin, Ho-sheng / Padhya, Tapan A / Mickelson, Sam / Anderson, W McDowell / Vanderveken, Olivier M / Strollo, Patrick J / Anonymous1440849. ·Medical College of Wisconsin, Milwaukee, Wisconsin, USA bwoodson@mcw.edu. · University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA. · Medical University of South Carolina, Charleston, South Carolina, USA. · Case Western Reserve University, Cleveland, Ohio, USA. · University Hospital Mannheim, Mannheim, Germany. · Saint Lucas Andreas Hospital, Amsterdam, Netherlands. · University of Cincinnati Medical Center, Cincinnati, Ohio, USA. · Wayne State University, Detroit, Michigan, USA. · University of South Florida College of Medicine, Tampa, Florida, USA. · Advanced ENT, Atlanta, Georgia, USA. · Antwerp University Hospital, Edegem, Belgium. ·Otolaryngol Head Neck Surg · Pubmed #26577774.

ABSTRACT: OBJECTIVE: To describe the 36-month clinical and polysomnography (PSG) outcomes in an obstructive sleep apnea (OSA) cohort treated with hypoglossal cranial nerve upper airway stimulation (UAS). STUDY DESIGN: A multicenter prospective cohort study. SETTING: Industry-supported multicenter academic and clinical setting. SUBJECTS: Participants (n = 116) at 36 months from a cohort of 126 implanted participants. METHODS: Participants were enrolled in a prospective phase III trial evaluating the efficacy of UAS for moderated to severe OSA. Prospective outcomes included apnea-hypopnea index, oxygen desaturation index, other PSG measures, self-reported measures of sleepiness, sleep-related quality of life, and snoring. RESULTS: Of 126 enrolled participants, 116 (92%) completed 36-month follow-up evaluation per protocol; 98 participants additionally agreed to a voluntary 36-month PSG. Self-report daily device usage was 81%. In the PSG group, 74% met the a priori definition of success with the primary outcomes of apnea-hypopnea index, reduced from the median value of 28.2 events per hour at baseline to 8.7 and 6.2 at 12 and 36 months, respectively. Similarly, self-reported outcomes improved from baseline to 12 months and were maintained at 36 months. Soft or no snoring reported by bed partner increased from 17% at baseline to 80% at 36 months. Serious device-related adverse events were rare, with 1 elective device explantation from 12 to 36 months. CONCLUSION: Long-term 3-year improvements in objective respiratory and subjective quality-of-life outcome measures are maintained. Adverse events are uncommon. UAS is a successful and appropriate long-term treatment for individuals with moderate to severe OSA.

22 Clinical Trial Effect of upper-airway stimulation for obstructive sleep apnoea on airway dimensions. 2015

Safiruddin, Faiza / Vanderveken, Olivier M / de Vries, Nico / Maurer, Joachim T / Lee, Kent / Ni, Quan / Strohl, Kingman P. ·Sint Lucas Andreas Hospital, Amsterdam, The Netherlands. · Dept of Otorhinolaryngology, Head and Neck Surgery, Antwerp University Hospital, Antwerp, Belgium Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp, Belgium. · Sint Lucas Andreas Hospital, Amsterdam, The Netherlands Dept of Otorhinolaryngology, Head and Neck Surgery, Antwerp University Hospital, Antwerp, Belgium Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp, Belgium. · University Medical Center Mannheim, Mannheim, Germany. · Inspire Medical Systems, Maple Grove, MN, USA. · Division of Pulmonary, Critical Care and Sleep Medicine, Case Medical Center, Case Western Reserve University, Cleveland, OH, USA kpstrohl@aol.com. ·Eur Respir J · Pubmed #25186270.

ABSTRACT: Upper-airway stimulation (UAS) using a unilateral implantable neurostimulator for the hypoglossal nerve is an effective therapy for obstructive sleep apnoea patients with continuous positive airway pressure intolerance. This study evaluated stimulation effects on retropalatal and retrolingual dimensions during drug-induced sedation compared with wakefulness to assess mechanistic relationships in response to UAS. Patients with an implanted stimulator underwent nasal video endoscopy while awake and/or during drug-induced sedation in the supine position. The cross-sectional area, anterior-posterior and lateral dimensions of the retropalatal and retrolingual regions were measured during baseline and stimulation. 15 patients underwent endoscopy while awake and 12 underwent drug-induced sedation endoscopy. Increased levels of stimulation were associated with increased area of both the retropalatal and retrolingual regions. During wakefulness, a therapeutic level of stimulation increased the retropalatal area by 56.4% (p=0.002) and retrolingual area by 184.1% (p=0.006). During stimulation, the retropalatal area enlarged in the anterior-posterior dimension while retrolingual area enlarged in both anterior-posterior and lateral dimensions. During drug-induced sedation endoscopy, the same stimulation increased the retropalatal area by 180.0% (p=0.002) and retrolingual area by 130.1% (p=0.008). Therapy responders had larger retropalatal enlargement with stimulation than nonresponders. UAS increases both the retropalatal and retrolingual areas. This multilevel enlargement may explain reductions of the apnoea-hypopnoea index in selected patients receiving this therapy.

23 Clinical Trial Upper-airway stimulation for obstructive sleep apnea. 2014

Strollo, Patrick J / Soose, Ryan J / Maurer, Joachim T / de Vries, Nico / Cornelius, Jason / Froymovich, Oleg / Hanson, Ronald D / Padhya, Tapan A / Steward, David L / Gillespie, M Boyd / Woodson, B Tucker / Van de Heyning, Paul H / Goetting, Mark G / Vanderveken, Oliver M / Feldman, Neil / Knaack, Lennart / Strohl, Kingman P / Anonymous180781. ·The authors' affiliations are listed in the Appendix. ·N Engl J Med · Pubmed #24401051.

ABSTRACT: BACKGROUND: Obstructive sleep apnea is associated with considerable health risks. Although continuous positive airway pressure (CPAP) can mitigate these risks, effectiveness can be reduced by inadequate adherence to treatment. We evaluated the clinical safety and effectiveness of upper-airway stimulation at 12 months for the treatment of moderate-to-severe obstructive sleep apnea. METHODS: Using a multicenter, prospective, single-group, cohort design, we surgically implanted an upper-airway stimulation device in patients with obstructive sleep apnea who had difficulty either accepting or adhering to CPAP therapy. The primary outcome measures were the apnea-hypopnea index (AHI; the number of apnea or hypopnea events per hour, with a score of ≥15 indicating moderate-to-severe apnea) and the oxygen desaturation index (ODI; the number of times per hour of sleep that the blood oxygen level drops by ≥4 percentage points from baseline). Secondary outcome measures were the Epworth Sleepiness Scale, the Functional Outcomes of Sleep Questionnaire (FOSQ), and the percentage of sleep time with the oxygen saturation less than 90%. Consecutive participants with a response were included in a randomized, controlled therapy-withdrawal trial. RESULTS: The study included 126 participants; 83% were men. The mean age was 54.5 years, and the mean body-mass index (the weight in kilograms divided by the square of the height in meters) was 28.4. The median AHI score at 12 months decreased 68%, from 29.3 events per hour to 9.0 events per hour (P<0.001); the ODI score decreased 70%, from 25.4 events per hour to 7.4 events per hour (P<0.001). Secondary outcome measures showed a reduction in the effects of sleep apnea and improved quality of life. In the randomized phase, the mean AHI score did not differ significantly from the 12-month score in the nonrandomized phase among the 23 participants in the therapy-maintenance group (8.9 and 7.2 events per hour, respectively); the AHI score was significantly higher (indicating more severe apnea) among the 23 participants in the therapy-withdrawal group (25.8 vs. 7.6 events per hour, P<0.001). The ODI results followed a similar pattern. The rate of procedure-related serious adverse events was less than 2%. CONCLUSIONS: In this uncontrolled cohort study, upper-airway stimulation led to significant improvements in objective and subjective measurements of the severity of obstructive sleep apnea. (Funded by Inspire Medical Systems; STAR ClinicalTrials.gov number, NCT01161420.).

24 Clinical Trial Implanted upper airway stimulation device for obstructive sleep apnea. 2012

Van de Heyning, Paul H / Badr, M Safwan / Baskin, Jonathan Z / Cramer Bornemann, Michel A / De Backer, Wilfried A / Dotan, Yaniv / Hohenhorst, Winfried / Knaack, Lennart / Lin, Ho-Sheng / Maurer, Joachim T / Netzer, Aviram / Odland, Rick M / Oliven, Arie / Strohl, Kingman P / Vanderveken, Olivier M / Verbraecken, Johan / Woodson, B Tucker. ·Department of Otorhinolaryngology and Head & Neck Surgery, Antwerp University Hospital, University of Antwerp, Antwerp, Belgium. paul.van.de.heyning@telenet.be ·Laryngoscope · Pubmed #22549513.

ABSTRACT: OBJECTIVES/HYPOTHESIS: Previous feasibility studies have shown that electrical stimulation of the hypoglossal nerve can improve obstructive sleep apnea (OSA). The current study examined the safety and preliminary effectiveness of a second generation device, the Upper Airway Stimulation (UAS) system, and identified baseline predictors for therapy success. STUDY DESIGN: Two consecutive open prospective studies. METHODS: UAS systems were implanted in patients with moderate to severe OSA who failed or were intolerant of continuous positive airway pressure (CPAP). The study was conducted in 2 parts. In part 1, patients were enrolled with broad selection criteria. Apnea hypopnea index (AHI) was collected using laboratory-based polysomnography at preimplant and postimplant visits. Epworth Sleepiness Scale (ESS) and Functional Outcomes of Sleep Questionnaire (FOSQ) were also collected. In part 2, patients were enrolled using selection criteria derived from the experience in part 1. RESULTS: In part 1, 20 of 22 enrolled patients (two exited the study) were examined for factors predictive of therapy response. Responders had both a body mass index ≤32 and AHI ≤50 (P < .05) and did not have complete concentric palatal collapse. Part 2 patients (n = 8) were selected using responder criteria and showed an improvement on AHI from baseline, from 38.9 ± 9.8 to 10.0 ± 11.0 (P < .01) at 6 months postimplant. Both ESS and FOSQ improved significantly in part 1 and 2 subjects. CONCLUSIONS: The current study has demonstrated that therapy with upper airway stimulation is safe and efficacious in a select group of patients with moderate to severe OSA who cannot or will not use CPAP as primary treatment.

25 Article Upper Airway Stimulation for Obstructive Sleep Apnea: Patient-Reported Outcomes after 48 Months of Follow-up. 2017

Gillespie, M Boyd / Soose, Ryan J / Woodson, B Tucker / Strohl, Kingman P / Maurer, Joachim T / de Vries, Nico / Steward, David L / Baskin, Jonathan Z / Badr, M Safwan / Lin, Ho-Sheng / Padhya, Tapan A / Mickelson, Sam / Anderson, W McDowell / Vanderveken, Olivier M / Strollo, Patrick J / Anonymous6490896. ·1 University of Tennessee, Memphis, Tennessee, USA. · 2 School of Medicine, University of Pittsburgh, Pittsburgh, PA, USA. · 3 Medical College of Wisconsin, Milwaukee, Wisconsin, USA. · 4 Case Western Reserve University, Cleveland, Ohio, USA. · 5 University Hospital Mannheim, Mannheim, Germany. · 6 OLVG Hospital and ACTA, Amsterdam, Netherlands. · 7 University of Cincinnati Medical Center, Cincinnati, Ohio, USA. · 8 Wayne State University, Detroit, Michigan, USA. · 9 University of South Florida College of Medicine, Tampa, Florida, USA. · 10 Advanced ENT, Atlanta, Georgia, USA. · 11 Antwerp University Hospital, Edegem, Belgium. ·Otolaryngol Head Neck Surg · Pubmed #28194999.

ABSTRACT: Objective To assess patient-based outcomes of participants in a large cohort study-the STAR trial (Stimulation Therapy for Apnea Reduction)-48 months after implantation with an upper airway stimulation system for moderate to severe obstructive sleep apnea. Study Design A multicenter prospective cohort study. Setting Industry-supported multicenter academic and clinical setting. Subjects Participants (n = 91) at 48 months from a cohort of 126 implanted participants. Methods A total of 126 participants received an implanted upper airway stimulation system in a prospective phase III trial. Patient-reported outcomes at 48 months, including Epworth Sleepiness Scale (ESS), Functional Outcomes of Sleep Questionnaire (FOSQ), and snoring level, were compared with preimplantation baseline. Results A total of 91 subjects completed the 48-month visit. Daytime sleepiness as measured by ESS was significantly reduced ( P = .01), and sleep-related quality of life as measured by FOSQ significantly improved ( P = .01) when compared with baseline. Soft to no snoring was reported by 85% of bed partners. Two patients required additional surgery without complication for lead malfunction. Conclusion Upper airway stimulation maintained a sustained benefit on patient-reported outcomes (ESS, FOSQ, snoring) at 48 months in select patients with moderate to severe obstructive sleep apnea.

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