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1.
J Clin Sleep Med ; 2024 Apr 24.
Artigo em Inglês | MEDLINE | ID: mdl-38656805

RESUMO

STUDY OBJECTIVES: Hypoglossal nerve stimulation (HGNS) has been widely used to treat obstructive sleep apnea in selected patients. Here we evaluate rates of revision and explant related to HGNS implantation and assess types of adverse events contributing to revision and explant. METHODS: Post-market surveillance data for HGNS implanted between January 1, 2018 and March 31, 2022, were collected. Event rates and risk were calculated using the post-market surveillance event counts and sales volume over the same period. Indications were categorized for analysis. Descriptive statistics were reported and freedom from explant or revision curves were grouped by year of implantation. RESULTS: Of the 20,881 HGNS implants assessed, rates of explant and revision within the first year were 0.723% and 1.542%, respectively. The most common indication for explant was infection (0.378%) and for revision was surgical correction (0.680%). Of the 5,820 devices with three-year post-implantation data, the rate of explant was 2.680% and of revision was 3.557%. During this same interval, elective removal (1.478%) was the most common indication, and for revisions, surgical correction (1.134%). CONCLUSIONS: The efficacy of HGNS is comparable in the real world setting to published clinical trial data. Rates of explant and revision are low, supporting a satisfactory safety profile for this technology.

2.
OTO Open ; 8(2): e134, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38646184

RESUMO

Objective: In patients undergoing hypoglossal nerve stimulation (HGNS), we examined the Insomnia Severity Index (ISI) to understand how baseline sleep onset insomnia (SOI), sleep maintenance insomnia (SMI), and early morning awakening (EMA) affected postsurgical outcomes. Study Design: Observational. Setting: Multicenter registry. Methods: We included patients from the Adherence and Outcomes of Upper Airway Stimulation for Obstructive Sleep Apnea International Registry (ADHERE) with a baseline ISI from 2020 to 2023. Regression analysis examined the association of ISI question scores for SOI, SMI, and EMA and outcomes: Apnea-Hypopnea Index (AHI) reduction, device usage, changes in the Epworth Sleepiness Scale (ESS) and overall ISI score, final visit (FV) completion, and satisfaction. Results: No relationship was noted between insomnia subtypes and AHI reduction or FV completion. In the subgroup of patients with baseline moderate/severe insomnia, patients with major impairment for SOI used their device 64 min/day longer than those with minimal impairment. Among all patients, those with baseline major impairment for SOI had a 2.3 points greater improvement in ISI from baseline to FV compared to patients with minimal impairment, while patients with baseline major impairment for SMI had a 2.0 and 3.5 points greater improvement in the ESS and ISI than those with minimal impairment. Patients with EMA and moderate/severe baseline insomnia had decreased odds of being satisfied after surgery. Conclusion: In ADHERE, nocturnal symptoms of insomnia did not limit HGNS efficacy or therapy use. Conversely, those with worse insomnia subtype impairments at baseline had improved outcomes related to adherence, sleepiness, and insomnia at the FV.

3.
J Sleep Res ; : e14178, 2024 Feb 22.
Artigo em Inglês | MEDLINE | ID: mdl-38385644

RESUMO

Oxidative stress in patients suffering from obstructive sleep apnea syndrome (OSAS) is associated with a low-grade systemic inflammation, immune disturbance, and increased invasion of monocytes into the endothelium. Besides continuous positive airway pressure (PAP), hypoglossal nerve stimulation (HNS) has become a promising treatment option for patients with OSAS. We aimed to analyse the influence of HNS therapy on the cellular characteristics relevant for adhesion and immune regulation of circulating CD14/CD16 monocyte subsets. Whole blood flow cytometric measurements were performed to analyse the expression levels of different adhesion molecules and checkpoint molecule PD-L1 (programmed death-ligand 1) in connection with pro-inflammatory plasma cytokine IL-8 and the clinical values of BMI (body mass index), AHI (apnea-hypopnea index), ODI (oxygen desaturation index), and ESS (Epworth sleepiness scale) upon HNS treatment. Hypoglossal nerve stimulation treatment significantly improved the expression of adhesion molecule CD162 (P-selectin receptor) on non-classical monocytes and significantly downregulated the expression of PD-L1 on all three monocyte subsets. We conclude that the holistic improvement of different parameters such as the oxygenation of the peripheral blood, a reduced systemic inflammation, and the individual sleeping situation upon HNS respiratory support, leads to an improved immunologic situation.

4.
Sci Rep ; 14(1): 340, 2024 01 03.
Artigo em Inglês | MEDLINE | ID: mdl-38172514

RESUMO

Obstructive sleep apnea syndrome (OSAS) and obesity go hand in hand in the majority of patients and both are associated with a systemic inflammation, immune disturbance and comorbidities such as cardiovascular disease. However, the unambiguous impact of OSAS and obesity on the individual inflammatory microenvironment and the immunological consequences of human monocytes has not been distinguished yet. Therefore, aim of this study was to investigate the impact of OSAS and obesity related factors on the inflammatory microenvironment by performing flow cytometric whole blood measurements of CD14/CD16 monocyte subsets in normal weight OSAS patients, patients with obesity but without OSAS, and patients with OSAS and obesity, compared to healthy donors. Moreover, explicitly OSAS and obesity related plasma levels of inflammatory mediators adiponectin, leptin, lipocalin and metalloproteinase-9 were determined and the influence of different OSAS and obesity related factors on cytokine secretion and expression of different adhesion molecules by THP-1 monocytes was analysed. Our data revealed a significant redistribution of circulating classical and intermediate monocytes in all three patient cohorts, but differential effects in terms of monocytic adhesion molecules CD11a, CD11b, CD11c, CX3CR1, CD29, CD49d, and plasma cytokine levels. These data were reflected by differential effects of OSAS and obesity related factors leptin, TNFα and hypoxia on THP-1 cytokine secretion patterns and expression of adhesion molecules CD11b and CD49d. In summary, our data revealed differential effects of OSAS and obesity, which underlines the need for a customized therapeutic regimen with respect to the individual weighting of these overlapping diseases.


Assuntos
Leptina , Apneia Obstrutiva do Sono , Humanos , Monócitos/metabolismo , Obesidade/metabolismo , Citocinas
5.
Immunohorizons ; 8(1): 19-28, 2024 Jan 01.
Artigo em Inglês | MEDLINE | ID: mdl-38175171

RESUMO

Obesity is characterized by excessive body fat accumulation and comorbidities such as diabetes mellitus, cardiovascular disease, and obstructive sleep apnea syndrome (OSAS). Both obesity and OSAS are associated with immune disturbance, alterations of systemic inflammatory mediators, and immune cell recruitment to metabolic tissues. Chemokine CXCL10 is an important regulator of proinflammatory immune responses and is significantly increased in patients with severe obesity. This research project aims to investigate the impact of CXCL10 on human monocytes in patients with obesity. We studied the distribution of the CD14/CD16 monocyte subsets as well as their CX3CR1 expression patterns in whole-blood measurements from 92 patients with obesity and/or OSAS with regard to plasma CXCL10 values and individual clinical parameters. Furthermore, cytokine secretion by THP-1 monocytes in response to CXCL10 was analyzed. Data revealed significantly elevated plasma CXCL10 in patients with obesity with an additive effect of OSAS. CXCL10 was found to drive monocytic secretion of macrophage migration inhibitory factor via receptor protein CX3CR1, which significantly correlated with the individual body mass index. Our data show, for the first time, to our knowledge, that CX3CR1 is involved in alternative CXCL10 signaling in human monocytes in obesity-related inflammation. Obesity is a multifactorial disease, and further investigations regarding the complex interplay between obesity-related inflammatory mediators and systemic immune balances will help to better understand and improve the individual situation of our patients.


Assuntos
Fatores Inibidores da Migração de Macrófagos , Apneia Obstrutiva do Sono , Humanos , Quimiocina CXCL10 , Receptor 1 de Quimiocina CX3C , Mediadores da Inflamação , Monócitos , Obesidade
6.
Sleep Breath ; 2023 Nov 06.
Artigo em Inglês | MEDLINE | ID: mdl-37926800

RESUMO

BACKGROUND: Patients with obstructive or central sleep apnea are primarily treated with positive airway pressure treatment. There are novel implantable options targeting either obstructive sleep apnea using hypoglossal nerve stimulation (HNS) or central sleep apnea using phrenic nerve stimulation (PNS). METHODS: Patients with sleep apnea were implanted with both HNS and PNS devices, and their response to each therapy was monitored using home sleep tests as well as Epworth Sleepiness scale (ESS). RESULTS: We evaluated our concurrent neurostimulation approach in two patients. Both patients were implanted with two neuromodulation devices: The first case suffered from treatment emergent central sleep apnea after HNS activation for primarily obstructive sleep apnea (apnea-hypopnea index/AHI 54/h). The central portion resolved under PNS (AHI 23.7/h). The second case suffered from predominantly central sleep apnea (AHI 82/h). Here, the PNS device was implanted first, resulting in a subsequent reduction of the central portion. The residual obstructive sleep apnea was addressed using HNS (AHI 5.4/h). No interaction between the HNS and PNS systems was noticed in either of the two patients. CONCLUSIONS: In selected cases, a concurrent treatment with hypoglossal and phrenic nerve stimulation may lead to improvement of sleep apnea and patient satisfaction in a safe manner.

7.
Otolaryngol Head Neck Surg ; 169(4): 1064-1069, 2023 10.
Artigo em Inglês | MEDLINE | ID: mdl-37003598

RESUMO

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.


Assuntos
Terapia por Estimulação Elétrica , Apneia Obstrutiva do Sono , Humanos , Resultado do Tratamento , Estudos Retrospectivos , Nervo Hipoglosso , Apneia Obstrutiva do Sono/terapia
8.
Immunohorizons ; 7(3): 191-199, 2023 03 01.
Artigo em Inglês | MEDLINE | ID: mdl-36921085

RESUMO

Obesity is a dramatically increasing disease, accompanied with comorbidities such as cardiovascular disease and obstructive sleep apnea syndrome (OSAS). Both obesity and OSAS per se are associated with systemic inflammation. However, the multifactorial impact of obesity, OSAS, and its concomitant diseases on the immunological characteristics of circulating monocytes has not yet been fully resolved. Monocyte subsets of 82 patients with obesity were analyzed in whole blood measurements in terms of the CD14/CD16 cell surface expression patterns and different monocytic adhesion molecules using flow cytometry. Plasma levels of adipokines adiponectin and leptin of all patients were evaluated and correlated with accompanying cellular and clinical values. Whole blood measurements revealed a significant overall redistribution of CD14/CD16 monocyte subsets in patients with obesity. Monocytic adhesion molecules CD11a, CD11b, and CX3CR1 were significantly elevated. The observed alterations significantly correlated with plasma leptin levels and diabetes status as crucial amplifying factors. The additive impact of obesity, diabetes, and OSAS on the immunological balance of peripheral blood monocytes requires a coordinated regimen in terms of therapeutic treatment, respiratory support, and weight loss to improve the systemic immunity in these patients.


Assuntos
Diabetes Mellitus , Apneia Obstrutiva do Sono , Humanos , Leptina , Monócitos , Obesidade , Apneia Obstrutiva do Sono/terapia
9.
Sleep Breath ; 27(2): 693-701, 2023 05.
Artigo em Inglês | MEDLINE | ID: mdl-35779166

RESUMO

PURPOSE: Hypoglossal nerve stimulation (HNS) has been shown to treat obstructive sleep apnea (OSA) effectively. The aim of this study was to compare HNS with positive airway pressure (PAP) treatment regarding outcome parameters: (1) sleepiness, (2) apnea-hypopnea index (AHI), and (3) effectiveness. METHODS: Propensity score matching with nearest neighbor algorithm was used to compare outcomes of HNS and PAP therapy in a real-world setting. Data were collected at baseline and 12 months after initiating OSA treatment including demographics, Epworth Sleepiness Scale (ESS), AHI, and objective adherence data. To account for overall treatment efficacy, the mean disease alleviation (MDA) was calculated. RESULTS: Of 227 patients who received treatment consecutively, 126 could be matched 1:1 with regard to age, body mass index, and AHI. After matching, no statistically significant differences between the groups were found. A clinically important symptom improvement was seen at 12 months in both cohorts, though there was a greater difference in ESS improvement in patients treated with HNS (8.0 ± 5.1 points vs. 3.9 ± 6.8 points; p = 0.042). In both groups, mean posttreatment AHI was significantly reduced (HNS: 8.1 ± 6.3/h; PAP: 6.6 ± 8.0/h; p < 0.001). Adherence after 12 months among patients treated with HNS was higher than in those receiving PAP therapy (5.0 ± 2.6 h/night; 4.0 ± 2.1 h/night) but not with statistical significance. Overall effectiveness calculated with the MDA was 59% in patients treated with HNS compared to 51% receiving PAP. CONCLUSION: Patients treated with HNS therapy had significantly greater improvements in daytime sleepiness compared to PAP therapy, while the mean reduction of AHI and overall effectiveness were comparable for both treatments. TRIAL REGISTRATION: ClinicalTrial.gov Identifier: NCT03756805.


Assuntos
Terapia por Estimulação Elétrica , Apneia Obstrutiva do Sono , Humanos , Pressão Positiva Contínua nas Vias Aéreas , Nervo Hipoglosso , Modalidades de Fisioterapia , Apneia Obstrutiva do Sono/terapia , Sonolência , Resultado do Tratamento
10.
J Sleep Res ; 32(1): e13592, 2023 02.
Artigo em Inglês | MEDLINE | ID: mdl-35596592

RESUMO

Hypoglossal nerve stimulation is an established treatment option for obstructive sleep apnea in selected patients. A unilateral hypoglossal nerve stimulation system was approved a decade ago, yet the physiological effect of unilateral hypoglossal stimulation on bilateral tongue motion remains unclear. This study examined how electrode configuration, stimulation cuff position, or body mass index influenced the contralateral genioglossus electromyography (EMG) signal. Twenty-nine patients underwent three EMG recordings in a polysomnographic setting after being implanted with a unilateral hypoglossal nerve stimulator for at least 6 months. The ratio of EMG signals between the ipsi- and contralateral sides was evaluated. No difference in EMG signals was demonstrated based on electrode configurations, stimulation-cuff position, body-mass-index, or sleep apnea severity, even in patients with right tongue protrusion only. Our findings may be explained by a significant level of cross-innervation and by a smaller and less variable circumferential electric field than expected based on prior biophysical models. A patient's individual anatomy needs to be considered during therapy titration in order to achieve an optimal response.


Assuntos
Terapia por Estimulação Elétrica , Síndromes da Apneia do Sono , Apneia Obstrutiva do Sono , Humanos , Nervo Hipoglosso/fisiologia , Apneia Obstrutiva do Sono/terapia , Eletrodos
11.
Front Neurol ; 14: 1275807, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-38162447

RESUMO

Sialorrhea is defined as a chronic excessive flow of saliva from the mouth, often with adverse consequences for health and quality of life of patients. In addition to currently used non-drug treatment and systemic drugs, intraglandular Botulinum Neurotoxin A (BoNT/A) injections have been examined in case studies, controlled trials and clinical practice. Two pivotal Phase III trials recently led to market approval in the USA and EU for IncobotulinumtoxinA [Xeomin®, IncoBoNT/A, Clostridium botulinum neurotoxin type A (150 kD), free from complexing proteins, Merz Pharmaceuticals GmbH] for treatment of chronic sialorrhea in adults and pediatric patients. This review provides a multidisciplinary approach to discuss the current state of sialorrhea therapy as well as benefits and current limitations of BoNT/A injections. A consensus regarding treatment recommendations made available to physicians in Germany in 2022 has now been updated here for presentation to an international audience. This review provides a framework including a flow chart for patient selection, recommendations for dosing and the injection process, as well as a discussion of therapeutic goals, long-term benefits and safety aspects. This review is aimed at supporting physicians in developing multidisciplinary and individualized treatment approaches to achieve optimal benefits for patients.

12.
Biomedicines ; 10(8)2022 Aug 09.
Artigo em Inglês | MEDLINE | ID: mdl-36009474

RESUMO

Background: Obstructive sleep apnea syndrome (OSAS) is a widespread respiratory disease that is associated with recurrent breathing intermissions at night. The corresponding oxidative stress triggers a low-grade systemic inflammation which leads to alterations of different immune cells in the peripheral blood. The current standard treatment for OSAS is continuous positive airway pressure (CPAP), whereas hypoglossal nerve stimulation (HNS) has been established as a second-line treatment option for CPAP failure. The aim of the study was to investigate the influence of HNS for OSAS patients on the distribution and differentiation of circulating monocyte subsets in connection with the clinical parameters. Materials and Methods: Therefore, a detailed analysis of the distribution of CD14/CD16 characterized monocyte subsets in the peripheral blood of OSAS patients before and after HNS therapy was performed by flow cytometry. Furthermore, values of BMI (body mass index), ODI (oxygen desaturation index), and ESS (Epworth Sleepiness Scale) were measured. Results: These OSAS patients significantly improved AHI and ESS scores under HNS. In addition, HNS revealed the potential to ensure normal distributions of blood monocyte subsets and even improved the monocyte dynamics in selected OSAS patients, but there were no significant correlations with AHI, ODI, HNS usage, and daytime sleepiness. Conclusions: We conclude that HNS-related positive effects on the oxygenation of the peripheral blood as well as affect the distribution of circulating monocyte subsets, but clinical OSAS correlations are missing. Far more individual clinical, cellular and molecular factors are involved in this sensitive and complex regulatory network and have to be elucidated in further studies.

13.
Laryngoscope Investig Otolaryngol ; 7(3): 877-884, 2022 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-35734047

RESUMO

Objective: Comorbid insomnia may impact outcomes of patients with obstructive sleep apnea (OSA) receiving hypoglossal nerve stimulation with respiratory sensing (HNS) therapy. To examine whether the presence of insomnia measured using the Insomnia Severity Index (ISI) is associated with patient-reported outcomes and objective OSA measures in patients receiving HNS therapy. Methods: In this retrospective chart review, patients with an HNS implant and ISI score at follow-up assessment were categorized as having moderate/severe insomnia or no/subthreshold insomnia. OSA-related data (Apnea Hypopnea Index, AHI; Oxygen Desaturation Index, ODI), Epworth Sleepiness Scale (ESS), Functional Outcomes of Sleep Questionnaire (FOSQ), and overall patient satisfaction was compared between these patient categories. Correlations between ISI scores and each of these variables were examined. Results: Of the 132 patients, 26% had moderate/severe insomnia at follow-up assessment. ESS and FOSQ scores were worse in the insomnia group at baseline, follow-up, and in the change from baseline, but AHI and ODI scores did not differ between patients with and without insomnia. Frequency of overall satisfaction at follow-up was lower in the insomnia group (58.8% vs. 92.8% with no insomnia, P < .001). Patients with insomnia were more likely to have depression (56% vs. 27% without insomnia, P < .002). Conclusions: Insomnia is associated with worse patient-reported outcomes of daytime sleepiness and sleep-related quality of life in patients with OSA receiving HNS therapy. Depression is more prevalent in patients with comorbid insomnia. The ISI may help physicians to address comorbid insomnia and achieve high patient satisfaction and adherence to HNS therapy. Level of Evidence: 4.

15.
Laryngorhinootologie ; 101(S 01): 103-113, 2022 05.
Artigo em Inglês, Alemão | MEDLINE | ID: mdl-35605615

RESUMO

Several neurostimulation devices exist for the treatment of various sleep-related breathing diseases. The most data for hypoglossal nerve stimulation (HNS) in the therapy of obstructive sleep apnea (OSA) derive the HNS with respiratory sensing. Herewith, daytime sleepiness measured with the Epworth Sleepiness Scale (ESS) was improved in several publications by 5 points with a stability shown for up to several years. Sleep related quality of life, documented with the Functional Outcomes of Sleep Questionnaire, increased by 2 points. In many cohorts showed a mean usage of 5 to 6 hours per night. Under the consideration of shorter follow-ups and smaller group sizes, the ESS improved by 4 under unilateral continuous HNS and by 3 under bilateral HNS. Transvenous stimulation of the phrenic nerve is approved for the treatment in central sleep apnea. In a pivotal trial with 5 year follow-up data, an ESS reduction is documented by 3 points. There is one publication describing a usage of more than 5 hours. The daytime enoral neuromuscular electrical therapy improved ESS (2 points) and sleep-related quality of life of the snoring patients and the bed partner. The daytime training for the effects during the night adherence is given with 83%. For all described devices, there are running or announced studies and/or registry trials that consider patient related outcome.


Assuntos
Terapia por Estimulação Elétrica , Apneia Obstrutiva do Sono , Pressão Positiva Contínua nas Vias Aéreas , Humanos , Nervo Hipoglosso , Qualidade de Vida , Sono , Apneia Obstrutiva do Sono/terapia , Resultado do Tratamento
16.
Fortschr Neurol Psychiatr ; 90(5): 222-232, 2022 May.
Artigo em Alemão | MEDLINE | ID: mdl-35453157

RESUMO

The most important salivary glands are the paired parotid and submandibular glands. Adults produce 1 to 1.5 liters of saliva which are then regularly swallowed. When the act of swallowing is disturbed, salivation occurs. More rarely, the cause can be found in increased saliva production, for example, when caused through medication. Sialorrhea impairs the quality of life substantially and is frequently often socially stigmatizing. Therapy includes conservative measures such as functional dysphagia therapy, oral or transdermal application of anticholinergics, as well as, in selected cases, radiation and surgical measures. Over the last 20 years, local injection of botulinum toxin has been successfully applied in the treatment of this condition. With approval of incobotulinumtoxinA toxin for children and adults, this procedure will become the therapy of choice for chronic sialorrhea. The results of the phase III registration trials have demonstrated high efficacy and good safety of the injection treatment in both children and adults.


Assuntos
Toxinas Botulínicas Tipo A , Sialorreia , Adulto , Toxinas Botulínicas Tipo A/uso terapêutico , Criança , Humanos , Qualidade de Vida , Glândulas Salivares , Salivação , Sialorreia/tratamento farmacológico , Sialorreia/etiologia , Glândula Submandibular , Resultado do Tratamento
17.
Fortschr Neurol Psychiatr ; 90(5): 212-221, 2022 May.
Artigo em Alemão | MEDLINE | ID: mdl-35453158

RESUMO

Sialorrhea, uncontrolled, excessive drooling, accompanies different, mostly neurological disorders from childhood to adulthood. With incobotulinumtoxinA (Xeomin, IncoBoNT/A, Merz Pharmaceuticals GmbH), an approved medication for the treatment of sialorrhea has been available since 2019. Patient selection, possible therapy goals, treatment and the management of specific treatment situations build the focus of this interdisciplinary expert consensus recommendations with the intent to facilitate access to treatment and to contribute to qualified botulinum toxin therapy.


Assuntos
Toxinas Botulínicas Tipo A , Doenças do Sistema Nervoso , Sialorreia , Adolescente , Adulto , Toxinas Botulínicas Tipo A/uso terapêutico , Criança , Consenso , Humanos , Sialorreia/tratamento farmacológico , Resultado do Tratamento , Adulto Jovem
18.
Neuromodulation ; 25(8): 1312-1316, 2022 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-34214238

RESUMO

OBJECTIVES: Hypoglossal nerve stimulation is an effective treatment option for obstructive sleep apnea (OSA) in positive airway pressure therapy failure. Nonetheless, data regarding the functional effect of modifying stimulation parameters within each electrode configuration are limited. MATERIALS AND METHODS: In a retrospective study of 76 patients with 12 months or more follow-up, functional tongue protrusion thresholds were compared for pulse width and frequency configurations of 90 µsec 33 Hz vs 120 µsec 40 Hz. The number of tolerated voltage amplitude steps between sensation, functional, and subdiscomfort thresholds were assessed for both settings as well as impedances. RESULTS: The overall cohort showed improvement in OSA metrics: median apnea-hypopnea index from 30.0/hour to 18.6/hour and Epworth Sleepiness Scale from 13.5 to 7.6. For both bipolar and unipolar electrode configurations, the stimulation amplitude required for functional tongue protrusion was significantly reduced when the pulse width and frequency were converted from 90 µsec 33 Hz to 120 µsec 40 Hz (p < 0.001). Nevertheless, the number of voltage amplitude steps from sensation, functional, to subdiscomfort thresholds did not differ between the two settings. The ratio of automatically derived impedances between bipolar and unipolar electrode configurations was relevantly correlated with the ratio of functional thresholds at these parameters. CONCLUSION: Changing the stimulation parameters may lower the voltage requirements while maintaining the same effect on tongue protrusion. Changing these stimulation parameters does not affect the range of tolerated impulse steps between functional and subdiscomfort thresholds. Future technical appliances could help estimate functional thresholds at different electrode configurations for each patient by automatically measuring impedances.


Assuntos
Terapia por Estimulação Elétrica , Apneia Obstrutiva do Sono , Humanos , Nervo Hipoglosso/fisiologia , Estudos Retrospectivos , Língua/inervação , Terapia por Estimulação Elétrica/efeitos adversos , Apneia Obstrutiva do Sono/terapia
19.
Eur Arch Otorhinolaryngol ; 279(1): 61-66, 2022 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-34151387

RESUMO

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.


Assuntos
Terapia por Estimulação Elétrica , Apneia Obstrutiva do Sono , Endoscopia , Humanos , Nervo Hipoglosso , Sono , Apneia Obstrutiva do Sono/diagnóstico , Apneia Obstrutiva do Sono/terapia
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