International expert consensus statement: surgical failure in obstructive sleep apnea.

PURPOSE: Upper airway (UA) surgery is commonly employed in the treatment of patients with obstructive sleep apnea (OSA). The intricate pathophysiology of OSA, variability in sites and patterns of UA collapse, and the interaction between anatomical and non-anatomical factors in individual patients may contribute to possible surgical failures. This clinical consensus statement aims to identify areas of agreement among a development group comprising international experts in OSA surgery, regarding the appropriate definition, predictive factors in patients, and management of surgical failure in OSA treatment. METHODS: A clinical consensus statement (CCS) was developed using the Delphi method by a panel of 35 contributors from various countries. A systematic literature review adhering to PRISMA guidelines was conducted. A survey consisting of 60 statements was then formulated and presented to the experts. RESULTS: Following two rounds of the Delphi process, consensus or strong consensus was achieved on 36 items, while 24 items remained without consensus. Specifically, 5 out of 10 statements reached consensus regarding on the 'Definition of Surgical Success/Failure after OSA Surgery'. Regarding the 'Predictive Factors of Surgical Failure in OSA Surgery', consensus was reached on 10 out of 13 statements. In the context of the 'Diagnostic Workup in OSA Surgery', consensus was achieved on 9 out of 13 statements. Lastly, in 'Treatment in Surgical Failure Cases', consensus was reached on 12 out of 24 statements. CONCLUSION: The management of OSA after surgical failure presents a significant clinical challenge for sleep specialists. This CCS provides valuable guidance for defining, preventing, and addressing surgical failures in the treatment of OSA syndrome.

Hypoglossal nerve stimulation for obstructive sleep apnea: updated position paper of the German Society of Oto-Rhino-Laryngology, Head and Neck Surgery.

Since the first statement of the German Society of Oto-Rhino-Laryngology, hypoglossal nerve stimulation (HNS) is meanwhile an established treatment option for obstructive sleep apnea (OSA). There are three HNS systems available in Germany which differ in their technical details of the underlying comparable basic principle. For the unilateral HNS with respiratory sensing, several comparative studies, high-volume register analysis and long-term reports exist. The continuous HNS without respiratory sensing does not require a sleep endoscopy for indication. For the bilateral continuous HNS as the single partially implantable device, a feasibility study exists. For indication, the assessment of positive airway pressure failure by sleep medicine is crucial, and the decision for HNS should be made in discussion of other treatment options for at least moderate OSA. The implantation center holds primarily responsibility among the interdisciplinary sleep team and is primary contact for the patient in problems. This depicts why structural processes are required to secure outcome quality and minimize the complications. The aftercare of HNS patients can be provided interdisciplinary and by different medical institutions, whereat, minimal reporting standards to document outcome and usage are recommended.

[Sleep medicine for the ENT specialist]. / Schlafmedizin für den Hals-Nasen-Ohren-Facharzt.

Sleep-related breathing disorders can be divided into obstructive and central sleep apnea, and hypoventilation syndromes. The diagnosis is made according to an algorithm in which clinical symptoms and a polygraphy or polysomnography usually point the way. After initial diagnosis of the most common obstructive sleep apnea, conservative therapies such as positive airway pressure therapy (PAP therapy), positional therapy, and/or mandibular advancement splint are used in many cases, supplemented by treatment of risk factors. If PAP therapy is not possible, more detailed diagnosis of airway obstruction, often with sleep videoendoscopy, is required. In general, "muscle-sparing" surgical techniques such as tonsillectomy with uvulapalatopharyngoplasty (TE-UPPP) should be considered whenever possible. This is especially important in the surgical treatment of snoring. More surgical therapy alternatives are for example barbed wire pharyngoplasty, tongue pacemaker and bimaxillary advancement. Optimal therapy alternatives should be evaluated in a sleep medicine center.

Maximum isometric tongue force in patients with obstructive sleep apnoea.

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

[Hypoglossal Nerve Stimulation in the Treatment of Obstructive Sleep Apnea]. / Die Hypoglossus-Stimulation zur Therapie der obstruktiven Schlafapnoe.

Reduced genioglossus muscle tone is considered one of the major causes for obstructive sleep apnea (OSA). Hypoglossal nerve stimulation (HNS) keeps the upper airway patent by increasing the muscle tone of the genioglossus muscle being the major airway opener. According to the German S3-Guideline on Sleep Disordered Breathing this treatment is indicated in patients with OSA failing or rejecting positive airway pressure, showing an AHI between 15 and 65, in particular when anatomy is normal and the BMI below 35. In 2021 it has been made available for regular patient care in Germany. However, breathing synchronized, continuous, and bilateral HNS differ in parts relevantly regarding their patient selection criteria, technical features, surgical technique, therapy setting and programming, and daily use for the patient. There are many publications showing the safety, efficacy, and patient satisfaction of breathing synchronized HNS. Less but promising data are available for continuous and the most recent bilateral HNS.

Die Stimulation des Nervus hypoglossus in der Behandlung der obstruktiven Schlafapnoe ­ Aktualisiertes Positionspapier der Arbeitsgemeinschaft Schlafmedizin der DGHNO-KHC.

Hypoglossal nerve stimulation for obstructive sleep apnea - Updated position paper of the German Society of Oto-Rhino-Laryngology, Head and Neck Surgery. Since the first statement of the German Society of Oto-Rhino-Laryngology, hypoglossal nerve stimulation (HNS) is meanwhile an established treatment option for obstructive sleep apnea (OSA). There are three HNS systems available in Germany which differ in their technical details of the underlying comparable basic principle. For the unilateral HNS with respiratory sensing, several comparative studies, high-volume register analysis and long-term reports exist. The continuous HNS without respiratory sensing does not require a sleep endoscopy for indication. For the bilateral continuous HNS as the single partially implantable device, a feasibility study exists. For indication, the assessment of positive airway pressure failure by sleep medicine is crucial, and the decision for HNS should be made in discussion of other treatment options for at least moderate OSA. The implantation center holds primarily responsibility among the interdisciplinary sleep team and is primary contact for the patient in problems. This depicts why structural processes are required to secure outcome quality and minimize complications. The aftercare of HNS patients can be provided interdisciplinary and by different medical institutions whereat minimal reporting standards to document outcome and usage are recommended.

Long-term follow-up of the German post-market study for upper airway stimulation for obstructive sleep apnea.

PURPOSE: Upper airway stimulation (UAS) is an effective treatment for obstructive sleep apnea (OSA) in positive airway pressure (PAP) failure. Most reports have presented short-term data, so long-term safety and efficacy reports are rare. The German post-market study (G-PMS) has followed approximately 60 patients from three implanting centers for several years. METHODS: Patients with OSA and PAP failure qualified for the G-PMS by the absence of obesity class 2 an AHI between 15 and 65 events/h and absence of complete concentric collapse at the velum during drug-induced sleep endoscopy. Optional 2- and 3-year follow-ups after implantation were collected during routine clinical practice. We measured respiratory parameters such as apnea-hypopnea index (AHI) and oxygen desaturation index (ODI) and daytime sleepiness using the Epworth sleepiness scale (ESS) in a per protocol analysis. Usage was calculated from device-downloaded reports. Device-related complications were documented. RESULTS: Of the 60 original patients, 41 returned for 2-year follow-up, and 38 for 3 years. About 76% at 2 years and 68% at 3 years met the criterion of therapy success defined as an AHI below 15/h. The median AHI was reduced from 28.6/h (baseline) to 9.0/h (2 years) and 10.0/h (3 years); whereas median ODI decreased from 27.0 to 6.3/h (2 years), and 8.3/h (3 years). Median ESS improved from baseline 13 points to 4 (2 years) and 6 (3 years). Usage was stable at approximately 45 h per week at 2 and 3 years. Serious device-related adverse events were rare, with two-device explantation between 12 to 36 months postoperatively. CONCLUSIONS: The German multi-center long-term outcomes compare favorably with previously published studies. Respiratory and sleepiness efficacy outcomes were sustained over 2 and 3 years, with a favorable safety profile, supporting the safety and efficacy of a chronic implantable therapy.

[Conservative treatment of obstructive sleep apnea using non-PAP therapies]. / Konservative Therapie der obstruktiven Schlafapnoe mit Nicht-PAP-Verfahren.

In Germany about one third of adults aged between 30 and 69 years suffer from obstructive sleep apnea (OSA). Snoring, inspiratory flow limitations, hypopneas, and apneas occur, leading to disturbed sleep, reduced daytime performance, and increased cardiovascular morbidity and mortality. Positive airway pressure therapy (PAP therapy) can be successfully administered in every OSA severity. However, other conservative treatments have to be considered for some patients, particularly in PAP failure or intolerance. The individual treatment concept is based on poly(somno)graphic, morphological, and functional assessment, taking treatment acceptance, adherence, and compliance into account.

Post-approval upper airway stimulation predictors of treatment effectiveness in the ADHERE registry.

Upper airway stimulation (UAS) has been shown to reduce severity of obstructive sleep apnoea. The aim of this study was to identify predictors of UAS therapy response in an international multicentre registry.Patients who underwent UAS implantation in the United States and Germany were enrolled in an observational registry. Data collected included patient characteristics, apnoea/hypopnoea index (AHI), Epworth sleepiness scale (ESS), objective adherence, adverse events and patient satisfaction measures. Post hoc univariate and multiple logistic regression were performed to evaluate factors associated with treatment success.Between October 2016 and January 2018, 508 participants were enrolled from 14 centres. Median AHI was reduced from 34 to 7 events·h-1, median ESS reduced from 12 to 7 from baseline to final visit at 12-month post-implant. In post hoc analyses, for each 1-year increase in age, there was a 4% increase in odds of treatment success. For each 1-unit increase in body mass index (BMI), there was 9% reduced odds of treatment success. In the multivariable model, age persisted in serving as statistically significant predictor of treatment success.In a large multicentre international registry, UAS is an effective treatment option with high patient satisfaction and low adverse events. Increasing age and reduced BMI are predictors of treatment response.

Upper-airway stimulation for obstructive sleep apnea.

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.).

The effect on snoring of using a pillow to change the head position.

PURPOSE: Although not a disease, primary snoring often leads to social problems. In an earlier retrospective pilot study, we found hints that individuals were snoring less in a lateral versus a supine head position. The aim of this study is to elucidate on the effect of an anti-snoring pillow which changes the head position. METHODS: We designed an interventional, controlled, and randomized crossover study. It included 22 participants, between 18 and 78 years, who snored, had a BMI ≤ 30, and a sleep partner. Obstructive sleep apnea was ruled out by polysomnography (PSG) or by respiratory polygraphy (PG). Two potential participants dropped out. The first two phases were done at home (4 weeks in total), followed by two nights of polysomnography in our sleep laboratory. During all phases, questionnaires regarding snoring, sleep quality, and pillow tolerance were completed by the patients and, as relevant, by their partners. RESULTS: The PSG parameters revealed a significant reduction in the snoring index (p = 0.03) when on the activated pillow without a deterioration in other respiratory parameters. This correlated well with the visual analog scale (VAS) that showed a significant decrease in snoring with the activated pillow according to the bed partners (p < 0.001). Subjective acceptance of the pillow during the study period was 100%. CONCLUSIONS: This study shows that by using a pillow to change the head position, it is possible to reduce both subjective and objective snoring severity. GERMAN CLINICAL TRIAL NUMBER: DRKS 00008744 AND ETHICS COMMISSION REGISTRY NUMBER REGISTRY NUMBER 2013-406 M-MA.

Effect of upper-airway stimulation for obstructive sleep apnoea on airway dimensions.

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.

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

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.

Stimulation of the internal superior laryngeal nerve as a potential therapy for obstructive sleep apnea in a porcine model.

Impaired pharyngeal sensing of negative pressure (NP) can lead to a blunted response of the upper airway dilator muscles and contribute to the development of obstructive sleep apnea (OSA). This response is modulated by the nerve fibers in the internal branch of the superior laryngeal nerve (iSLN), mediating negative pressure sensation. Artificial excitation of these fibers could be a potential treatment target for OSA. To evaluate this, electrostimulation of the iSLN was performed in a porcine-isolated upper airway model. Artificial obstructions were induced by varying the levels of negative pressure, and the ability of the animal to resolve these obstructions was evaluated. The pressure at which the animal was still able to resolve the obstruction was quantified as "Resolvable Pressure." Thereby, the effects on pharyngeal patency (n = 35) and the duration of the therapeutic effect outlasting the stimulation (n = 6) were quantified. Electrostimulation before the introduction of an artificial obstruction improved the median resolvable pressure from -28.3 cmH2O [IQR: -45.9; -26.1] to -92.6 cmH2O [IQR: -105.1; -78.6]. The median therapeutic effect was found to outlast the last stimulation burst applied by 163 s when five stimulation bursts were applied in short succession [IQR: 58; 231], 58 s when two were applied [IQR: 7; 65], and 6 s when one was applied [IQR: 0; 51]. Stimulation of the iSLN increased electromyography (EMG) in the genioglossus (GG). The proposed treatment concept can improve pharyngeal patency in the model. Transfer of the results to clinical application could enable the development of a new neuromodulation therapy for OSA.NEW & NOTEWORTHY Electrostimulation before the introduction of an artificial obstruction to induce artificial sleep apnea in the pig model improves the response of the upper airway to negative pressure (NP). The electrostimulation creates a sustained therapeutic effect that outlasts the initial electrostimulation. The use of this therapy in clinical practice has the potential to treat obstructive sleep apnea (OSA).

Does drug-induced sleep endoscopy change the treatment concept of patients with snoring and obstructive sleep apnea?

PURPOSE: Success rates of non-ventilation therapies for sleep disordered breathing (SDB) remain hardly acceptable. Drug-induced sleep endoscopy (DISE) tends to show the level and mechanism of obstruction and helps to specify therapy individually. Therefore, increasing success rates are expected. The objective of this study is to detect whether locations of treatment recommendations given after DISE are different to those made after clinical basic ENT (ear, nose, throat) examination (CBE). METHODS: This study included patients with obstructive sleep apnea (OSA) and primary snoring who wish or require an alternative therapy to the gold standard, continuous positive airway pressure (CPAP). After CBE, a theoretical treatment recommendation was given comprising surgery (possible surgical target: soft palate, tonsils, tongue base, epiglottis) and mandibular advancement splints (MAS) or both. A second ENT specialist conducted a DISE and independently recommended a second therapy concept without knowing the first one. A third person compared both theoretical locations of treatment recommendations (CBE vs. DISE). RESULTS: A total of 97 patients (eight female and 89 male, age 30-85 years, AHI 1.9-88.6/h, body mass index [BMI] 20.3-36.3 kg/m²) received two therapy recommendations. Regarding surgical options only, 63.9% of the examined patients got a different recommendation in at least one of four levels. If MAS was included, a change was found in 78.4% of the patients. Subdivided into each type of intervention, the following changes were found in the therapy concept: 24.7% (n = 24/97) soft palate, 12.4% (n = 12/97) tonsils, 33.0% (n = 32/97) tongue base, 27.8% (n = 27/97) epiglottis, 38.1% (n = 37/97) MAS. CONCLUSIONS: DISE shows a relevant influence on the location of treatment recommendation. Thus, a change in success rates of non-CPAP therapy in OSA and snoring appears possible.

Long-Term Generator Replacement Experience in Hypoglossal Nerve Stimulator Therapy Recipients With CPAP-Intolerant Obstructive Sleep Apnea.

OBJECTIVE: In the last decade, hypoglossal nerve stimulation (HNS) has emerged as a therapeutic alternative for patients with obstructive sleep apnea. The original clinical trial cohorts are entering the phase of expected battery depletion (8-12 years). This study aimed to examine the surgical experience with implantable pulse generator (IPG) replacements and the associated long-term therapy outcomes. STUDY DESIGN: Retrospective analysis of patients from the original clinical trial databases (STAR, German post-market) who were followed in the ongoing ADHERE registry. SETTING: International multicenter HNS registry. METHODS: The ADHERE registry and clinical trial databases were cross-referenced to identify the serial numbers of IPGs that were replaced. Data collection included demographics, apnea-hypopnea index (AHI), therapy use, operative times, and adverse events. RESULTS: Fourteen patients underwent IPG replacement 8.3 ± 1.1 years after their initial implantation. Body mass index was unchanged between the original implant and IPG replacement (29 ± 4 vs 28 ± 2 kg/m2 , p = .50). The mean IPG replacement operative time was shorter than the original implant (63 ± 50 vs 154 ± 58 minutes, p < .002); however, 2 patients required stimulation lead replacement which significantly increased operative time. For patients with available AHI and adherence data, the mean change in AHI from baseline to latest follow-up (8.7 ± 1.1 years after de novo implant) was -50.06%, and the mean therapy use was 7.2 hours/night. CONCLUSION: IPG replacement surgery was associated with low complications and shorter operative time. For patients with available outcomes data, adherence and efficacy remained stable after 9 years of follow-up.

Targeted Hypoglossal Nerve Stimulation for Patients With Obstructive Sleep Apnea: A Randomized Clinical Trial.

Importance: Evidence is lacking from randomized clinical trials of hypoglossal nerve stimulation in obstructive sleep apnea (OSA). Objective: To evaluate the safety and effectiveness of targeted hypoglossal nerve stimulation (THN) of the proximal hypoglossal nerve in patients with OSA. Design, Setting, and Participants: This randomized clinical trial (THN3) was conducted at 20 centers and included 138 patients with moderate to severe OSA with an apnea-hypopnea index (AHI) of 20 to 65 events per hour and body mass index (calculated as weight in kilograms divided by height in meters squared) of 35 or less. The trial was conducted from May 2015 through June 2018. Data were analyzed from January 2022 through January 2023. Intervention: Implant with THN system; randomized 2:1 to activation at month 1 (treatment) or month 4 (control). All received 11 months of THN with follow-up at months 12 and 15, respectively. Main Outcomes and Measures: Primary effectiveness end points comprised AHI and oxygen desaturation index (ODI) responder rates (RRs). Treatment responses at months 4 and 12/15 were defined as a 50% or greater reduction in AHI to 20 or less per hour and an ODI decrease of 25% or greater. Coprimary end points comprised (1) month 4 AHI and ODI RR in the treatment greater than the control group and (2) month 12/15 AHI and ODI RR in the entire cohort exceeding 50%. Secondary end points included sleep apnea severity (AHI and ODI) and patient-reported outcomes (Epworth Sleepiness Scale, Functional Outcomes of Sleep Questionnaire, and EQ-5D visual analog scale). Results: Among 138 participants, the mean (SD) age was 56 (9) years, and 19 (13.8%) were women. Month 4 THN RRs were substantially greater in those in the treatment vs control group (AHI, 52.3% vs 19.6%; ODI, 62.5% vs 41.3%, respectively) with treatment-control standardized mean differences of 0.725 (95% CI, 0.360-1.163) and 0.434 (95% CI, 0.070-0.843) for AHI and ODI RRs, respectively. Months 12/15 RRs were 42.5% and 60.4% for AHI and ODI, respectively. Improvements in AHI, ODI, Epworth Sleepiness Scale, Functional Outcomes of Sleep Questionnaire, and EQ-5D visual analog scale scores were all clinically meaningful (medium to large effect size). Two serious adverse events and 100 nonserious related adverse events were observed from the implant procedure or study protocol. Conclusions and Relevance: This randomized clinical trial found that THN demonstrated improvements in sleep apnea, sleepiness, and quality of life in patients with OSAs over an extended AHI and body mass index range without prior knowledge of pharyngeal collapse pattern. Clinically meaningful improvements in AHI and patient-reported responses compared favorably with those of distal hypoglossal nerve stimulation trials, although clinically meaningful differences were not definitive for ODI. Trial Registration: ClinicalTrials.gov Identifier: NCT02263859.

Effects of continuous positive airway pressure on apnea-hypopnea index in obstructive sleep apnea based on long-term compliance.

PURPOSE: Although continuous positive airway pressure (CPAP) is the gold standard in the treatment of obstructive sleep apnea (OSA), its effectiveness depends on the regular use. In this retrospective study, the effectiveness of CPAP with regard to the reduction of the apnea-hypopnea index was calculated based on individual adherence data extracted from a cohort of patients with OSA METHODS: The electronic database was analyzed for follow-up visits of patients receiving CPAP for OSA. The following information was extracted the charts of 750 patients: apnea-hypopnea index (AHI) at diagnosis, AHI with CPAP, duration of therapy, hours of CPAP use, and subjective hours of sleep. Eighty-two successfully treated and stable CPAP patients (AHI/Epworth Sleepiness Scale (ESS) at baseline 35.6 ± 22.1/10.5 ± 5.1) could be further evaluated. RESULTS: Mean AHI under CPAP was 2.4 ± 2.5 with an ESS of 6.9 ± 4.2. Subjective hours of sleep were 6.5 ± 1.1. The average treatment period was 584.6 ± 566.5 days (3,800 h of sleep). Mean hours of use was 2,712 ± 3,234 (4.69 ± 2.42 per night). This leads to the following calculated measures: hours of sleep without CPAP, 1,088; number of respiratory events with CPAP, 6508.8; number of respiratory events without CPAP, 38,732.8; total number or respiratory events, 45,241.6; average AHI, 11.91. CONCLUSIONS: Even in an ideal group of patients, CPAP cannot eliminate respiratory events due to limited adherence. Adherence needs to be taken into account when comparing the effects of CPAP on the AHI with alternative treatment methods, especially those with 100% adherence (e.g., surgery).

Effect of Upper Airway Stimulation in Patients with Obstructive Sleep Apnea (EFFECT): A Randomized Controlled Crossover Trial.

BACKGROUND: Several single-arm prospective studies have demonstrated the safety and effectiveness of upper airway stimulation (UAS) for obstructive sleep apnea. There is limited evidence from randomized, controlled trials of the therapy benefit in terms of OSA burden and its symptoms. METHODS: We conducted a multicenter, double-blinded, randomized, sham-controlled, crossover trial to examine the effect of therapeutic stimulation (Stim) versus sham stimulation (Sham) on the apnea-hypopnea index (AHI) and the Epworth Sleepiness Scale (ESS). We also examined the Functional Outcomes of Sleep Questionnaire (FOSQ) on sleep architecture. We analyzed crossover outcome measures after two weeks using repeated measures models controlling for treatment order. RESULTS: The study randomized 89 participants 1:1 to Stim (45) versus Sham (44). After one week, the AHI response rate was 76.7% with Stim and 29.5% with Sham, a difference of 47.2% (95% CI: 24.4 to 64.9, p < 0.001) between the two groups. Similarly, ESS was 7.5 ± 4.9 with Stim and 12.0 ± 4.3 with Sham, with a significant difference of 4.6 (95% CI: 3.1 to 6.1) between the two groups. The crossover phase showed no carryover effect. Among 86 participants who completed both phases, the treatment difference between Stim vs. Sham for AHI was -15.5 (95% CI -18.3 to -12.8), for ESS it was -3.3 (95% CI -4.4 to -2.2), and for FOSQ it was 2.1 (95% CI 1.4 to 2.8). UAS effectively treated both REM and NREM sleep disordered breathing. CONCLUSIONS: In comparison with sham stimulation, therapeutic UAS reduced OSA severity, sleepiness symptoms, and improved quality of life among participants with moderate-to-severe OSA.

Intra- and Extrathoracic Malignant Tracheoesophageal Fistula-A Differentiated Reconstructive Algorithm.

BACKGROUND: Tracheoesophageal fistulae (TEF) after oncologic resections and multimodal treatment are life-threatening and surgically challenging. Radiation and prior procedures hamper wound healing and lead to high complication rates. We present an interdisciplinary algorithm for the treatment of TEF derived from the therapy of consecutive patients. PATIENTS AND METHODS: 18 patients (3 females, 15 males) treated for TEF from January 2015 to July 2017 were included. Two patients were treated palliatively, whereas reconstructions were attempted in 16 cases undergoing 24 procedures. Discontinuity resection and secondary gastric pull-up were performed in two patients. Pedicled reconstructions were pectoralis major (n = 2), sternocleidomastoid muscle (n = 2), latissimus dorsi (n = 1) or intercostal muscle (ICM, n = 7) flaps. Free flaps were anterolateral thigh (ALT, n = 4), combined anterolateral thigh/anteromedial thigh (ALT/AMT, n = 1), jejunum (n = 3) or combined ALT-jejunum flaps (n = 2). RESULTS: Regarding all 18 patients, 11 of 16 reconstructive attempts were primarily successful (61%), whereas long-term success after multiple procedures was possible in 83% (n = 15). The 30-day survival was 89%. Derived from the experience, patients were divided into three subgroups (extrathoracic, cervicothoracic, intrathroracic TEF) and a treatment algorithm was developed. Primary reconstructions for extra- and cervicothoracic TEF were pedicled flaps, whereas free flaps were used in recurrent or persistent cases. Pedicled ICM flaps were mostly used for intrathoracic TEF. CONCLUSION: TEF after multimodal tumor treatment require concerted interdisciplinary efforts for successful reconstruction. We describe a differentiated reconstructive approach including multiple reconstructive techniques from pedicled to chimeric ALT/jejunum flaps. Hereby, successful reconstructions are mostly possible. However, disease and patient-specific morbidity has to be anticipated and requires further interdisciplinary management.