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International Journal of Environmental... Feb 2021Obstructive sleep apnea (OSA) is a common sleep disorder that affects all age groups and is associated with many co-morbid diseases (especially cardiovascular diseases).... (Review)
Review
Obstructive sleep apnea (OSA) is a common sleep disorder that affects all age groups and is associated with many co-morbid diseases (especially cardiovascular diseases). Continuous positive airway pressure (CPAP) is the gold standard for treating OSA. However, adherence to PAP therapy has been a major challenge with an estimated adherence between 20% and 80%. Mandibular advancement devices (MAD) are a good alternative option if used in the appropriate patient. MAD are most effective in mild and moderate OSA but not severe OSA. Surgical options are invasive, not appropriate for severe OSA, and associated with pain and long healing time. Hypoglossal nerve stimulation (HGNS), or upper airway stimulation (UAS), is a novel therapy in treating moderate and severe degrees of OSA in patients who cannot tolerate CPAP therapy. We reviewed the MEDLINE (PubMed) database. The search process yielded 303 articles; 31 met the inclusion and exclusion criteria and were included. We concluded that hypoglossal nerve stimulation is a very effective and novel alternative therapy for moderate and severe OSA in patients who cannot tolerate CPAP therapy. Adherence to HGNS is superior to CPAP. However, more developments are needed to ensure the highest safety profile.
Topics: Continuous Positive Airway Pressure; Electric Stimulation Therapy; Humans; Hypoglossal Nerve; Mandibular Advancement; Sleep Apnea, Obstructive
PubMed: 33572156
DOI: 10.3390/ijerph18041642 -
JAMA Otolaryngology-- Head & Neck... Jun 2023Evidence is lacking from randomized clinical trials of hypoglossal nerve stimulation in obstructive sleep apnea (OSA).
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.
Topics: Humans; Female; Middle Aged; Male; Hypoglossal Nerve; Quality of Life; Sleepiness; Sleep Apnea, Obstructive; Sleep Apnea Syndromes
PubMed: 37022679
DOI: 10.1001/jamaoto.2023.0161 -
Chest Dec 2018Over the past 30 years, hypoglossal nerve stimulation has moved through a development pathway to become a viable treatment modality for patients with OSA. Initial pilot... (Review)
Review
Over the past 30 years, hypoglossal nerve stimulation has moved through a development pathway to become a viable treatment modality for patients with OSA. Initial pilot studies in animals and humans laid the conceptual foundation for this approach, leading to the development of fully implantable stimulating systems for therapeutic purposes. These devices were then shown to be both safe and efficacious in feasibility studies. One such closed-loop stimulating device was found to be effective in treating a limited spectrum of apneic patients and is currently approved by the US Food and Drug Administration for this purpose. Another open-loop stimulating system is currently being rigorously tested in a pivotal trial. Collectively, clinical trials of hypoglossal nerve stimulating systems have yielded important insights that can help optimize therapeutic responses to hypoglossal nerve stimulation. These insights include specific patient selection criteria and methods for delivering stimulation to specific portions of the hypoglossal nerve and/or genioglossus muscle. New approaches for activating efferent and afferent motor pathways are currently in early-stage laboratory development and hold some long-term promise as a novel therapy.
Topics: Electric Stimulation Therapy; Humans; Hypoglossal Nerve; Patient Selection; Sleep Apnea, Obstructive; Treatment Outcome
PubMed: 30222959
DOI: 10.1016/j.chest.2018.08.1070 -
BMC Oral Health Jun 2022Schwannomas or neurilemmomas are well-encapsulated, benign, solitary, and slow-growing tumors that originate from Schwann cells of the nerve sheath. Extracranial...
BACKGROUND
Schwannomas or neurilemmomas are well-encapsulated, benign, solitary, and slow-growing tumors that originate from Schwann cells of the nerve sheath. Extracranial schwannoma is reported to have a relatively high incidence in the tongue while an extremely low incidence in the floor of mouth. In the current study, we presented the first case series of hypoglossal nerve-derived schwannoma in the floor of mouth in Asia.
METHODS
A retrospective study of 9 surgical cases of hypoglossal nerve-derived schwannoma in the floor of mouth was performed. The patient and tumor characteristics were evaluated by physical, radiological and pathological examination. Details of operation and complications were also recorded.
RESULTS
Hypoglossal nerve-derived schwannoma in the floor of mouth showed a well-defined boundary with a firm texture, smooth surface and good mobility on palpation. The median maximum diameter of the tumors was 4.3 cm (range 2.8-7.0 cm). The median operative time and bleeding volumes were 89.4 min (range 47-180 min) and 99.2 mL (range 15-200 mL), respectively. All cases received complete surgical excision.
CONCLUSION
In this study, we presented the diagnosis and management of hypoglossal nerve-derived schwannoma in the floor of mouth for the first time in Asia. The study provided us with a recommendation for consideration of the diagnosis of hypoglossal schwannoma when a patient presents with a mass in the floor of mouth.
Topics: Cranial Nerve Neoplasms; Humans; Hypoglossal Nerve; Hypoglossal Nerve Diseases; Mouth Floor; Neurilemmoma; Retrospective Studies
PubMed: 35768820
DOI: 10.1186/s12903-022-02302-2 -
ORL; Journal For Oto-rhino-laryngology... 2023Upper airway stimulation via the hypoglossal nerve stimulator (HGNS) implant is a surgical method for treating obstructive sleep apnea. However, patients may need the...
INTRODUCTION
Upper airway stimulation via the hypoglossal nerve stimulator (HGNS) implant is a surgical method for treating obstructive sleep apnea. However, patients may need the implant removed for a variety of reasons. The purpose of this case series is to assess surgical experiences with HGNS explantation at our institution. We report on surgical approach, overall operative times, operative and postoperative complications, and discuss relevant patient-specific surgical findings when removing the HGNS.
METHODS
We performed a retrospective case series of all patients that underwent HGNS implantation at a single tertiary medical center between January 9, 2021, and January 9, 2022. Subjects included adult patients who presented to the sleep surgery clinic of the senior author for surgical management of previously implanted HGNS. Patient clinical history was reviewed to determine the timing of the patient's implant, reasons for explant, and postoperative recovery course. Operative reports were reviewed to determine overall duration of surgery and any associated difficulties or deviations from the general approach.
RESULTS
Between January 9, 2021, and January 9, 2022, 5 patients had an explantation of their HGNS implant. Explantation occurred between 8 and 63 months of their original implant surgery. The average operative time from incisional start time to close was 162 min for all cases with a range of 96-345 min. No significant complications were reported including pneumothorax and nerve palsy.
CONCLUSION
This reported case series outlines the general steps for Inspire HGNS explantation as well as details the experiences in a case series of 5 subjects explanted over the year at a single institution. The results from the cases suggest that the explantation of the device can be performed efficiently and safely.
Topics: Adult; Humans; Electric Stimulation Therapy; Hypoglossal Nerve; Polysomnography; Retrospective Studies; Sleep Apnea, Obstructive
PubMed: 36796344
DOI: 10.1159/000529011 -
Journal of Clinical Sleep Medicine :... May 2022Hypoglossal nerve stimulation (HGNS) is an effective alternative treatment for obstructive sleep apnea that acts by opening the airway via selective stimulation of nerve...
STUDY OBJECTIVES
Hypoglossal nerve stimulation (HGNS) is an effective alternative treatment for obstructive sleep apnea that acts by opening the airway via selective stimulation of nerve fibers that innervate tongue muscles that protrude (genioglossus) and stiffen the tongue (transverse and vertical) while avoiding nerve fibers that innervate tongue muscles that retract the tongue (styloglossus and hyoglossus). There remains a subset of postoperative patients who fail to adequately respond to HGNS, in some cases due to mixed activation of muscles that simultaneously protrude and retract the tongue. This study aims to characterize the relationship between neurophysiological data from individual tongue muscle activation during intraoperative electromyographic recordings and postoperative apnea-hypopnea index responses to HGNS.
METHODS
A single-institution review of 46 patients undergoing unilateral HGNS implantation for obstructive sleep apnea. Patients were separated into and through comparison of pre and postoperative apnea-hypopnea index. Neurophysiological data included electromyographic responses of the genioglossus, styloglossus/hyoglossus, intrinsic/vertical, and hyoglossus (neck) muscles to intraoperative stimulation using unipolar (- to - and o to o) and bipolar (+ to +) settings.
RESULTS
The overall treatment success rate was 61% as determined by a postoperative apnea-hypopnea index < 20 events/h with a greater than 50% AHI reduction. We observed no statistically significant relationships between treatment response and individual muscle responses. However, we did note that increasing body mass index was correlated with worse postoperative responses.
CONCLUSIONS
Although we noted a significant subgroup of clinical nonresponders to HGNS postoperatively, these patients were not found to exhibit significant inclusion of tongue retractors intraoperatively on neurophysiological analysis. Further research is needed to delineate additional phenotypic factors that may contribute to HGNS treatment responses.
CITATION
Wang D, Modik O, Sturm JJ, et al. Neurophysiological profiles of responders and nonresponders to hypoglossal nerve stimulation: a single-institution study. . 2022;18(5):1327-1333.
Topics: Electric Stimulation Therapy; Facial Muscles; Humans; Hypoglossal Nerve; Sleep Apnea, Obstructive; Tongue
PubMed: 34964435
DOI: 10.5664/jcsm.9852 -
Otolaryngology--head and Neck Surgery :... Jan 2021Hypoglossal nerve stimulation for obstructive sleep apnea (OSA) can be effective for appropriately selected patients, but current patient selection criteria are complex...
OBJECTIVE
Hypoglossal nerve stimulation for obstructive sleep apnea (OSA) can be effective for appropriately selected patients, but current patient selection criteria are complex and still result in a proportion of nonresponders. Ansa cervicalis stimulation of the infrahyoid cervical strap muscles has recently been proposed as a new form of respiratory neurostimulation (RNS) therapy for OSA treatment. We hypothesized that percutaneous stimulation of both nerves in humans with temporary electrodes would make testing of the physiologic response to different RNS strategies possible.
STUDY DESIGN
Nonrandomized acute physiology study.
SETTING
Tertiary care hospital.
METHODS
Fifteen participants with OSA underwent ultrasonography and placement of percutaneous electrodes proximal to the medial division of the hypoglossal nerve and the branch of the ansa cervicalis innervating the sternothyroid muscle (AC). Procedural success was documented in each participant, as were any failures or procedural complication.
RESULTS
The hypoglossal nerve was successfully localized in 15 of 15 (100%) participants and successfully stimulated in 13 of 15 (86.7%). The AC was successfully localized in 15 of 15 (100%) participants and successfully stimulated in 14 of 15 (93.3%). Stimulation failure of the hypoglossal nerve was due to suboptimal electrode placement in 1 participant and electrode displacement in the other 2 cases. No complications occurred.
CONCLUSIONS
The hypoglossal nerve and AC can be safely stimulated via percutaneous electrode placement. Larger trials of percutaneous stimulation may help to identify responders to different RNS therapies for OSA with temporary or permanent percutaneous electrodes. Techniques for electrode design, nerve localization, and electrode placement are described.
Topics: Electric Stimulation Therapy; Female; Humans; Hypoglossal Nerve; Male; Middle Aged; Sleep Apnea, Obstructive; Ultrasonography
PubMed: 33076752
DOI: 10.1177/0194599820959275 -
Journal of Clinical Sleep Medicine :... Nov 2018
Topics: Cardiovascular Diseases; Humans; Hypoglossal Nerve; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
PubMed: 30373702
DOI: 10.5664/jcsm.7470 -
Sleep Nov 2022
Topics: Humans; Hypoglossal Nerve; Continuous Positive Airway Pressure; Sleep Apnea, Obstructive; Electric Stimulation Therapy; Medication Adherence
PubMed: 35439817
DOI: 10.1093/sleep/zsac086 -
Cleveland Clinic Journal of Medicine Sep 2019Positive airway pressure (PAP) therapy is the gold standard treatment for patients with obstructive sleep apnea (OSA) and has been shown to positively impact quality of... (Review)
Review
Positive airway pressure (PAP) therapy is the gold standard treatment for patients with obstructive sleep apnea (OSA) and has been shown to positively impact quality of life and cardiovascular outcomes. However, not all patients with OSA can use or tolerate PAP therapy. Alternative interventions to PAP include lifestyle measures, surgical interventions, hypoglossal nerve stimulation, oral appliance therapy, and expiratory PAP devices for OSA. While these alternative interventions may benefit patients and have demonstrated improvements in OSA and quality-of-life measures, the cardiovascular impact of these interventions is uncertain as data are limited.
Topics: Electric Stimulation Therapy; Humans; Hypoglossal Nerve; Life Style; Nasal Surgical Procedures; Positive-Pressure Respiration; Respiratory Therapy; Sleep Apnea, Obstructive
PubMed: 31509502
DOI: 10.3949/ccjm.86.s1.06