Association between anxiety, depression, and emotional distress and hypoglossal nerve stimulator adherence.

PURPOSE: To evaluate relationships between hypoglossal nerve stimulator (HNS) adherence and the presence of anxiety, depression, and emotional distress. METHODS: This is a cross-sectional study of subjects with moderate to severe obstructive sleep apnea (OSA), who had HNS implanted and activated at The Ohio State University Medical Center (OSUMC). Patient usage data from the previous 6 months was obtained from 33 patients. Adherence was defined as ≥28 h of use per week. Generalized Anxiety Disorder-7 (GAD-7) and Patient Health Questionnaire-9 (PHQ-9) were administered, and the Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS) score was calculated for all subjects. RESULTS: Sixty-five percent were adherent with average usage of 46.5±11.7 h per week vs 7.7±7.5 h per week in the non-adherent group. The average GAD-7 were 3.90±3.98 in the adherent group vs. 8.27±6.69 in the non-adherent group (p=0.049). PHQ-9 score was 6.15±4.31 vs. 10.09±7.53 (p=0.118), and PHQ-ADS was 10.05±7.49 vs. 19.20±9.80 (p=0.035). There were no statistically significant differences in age, gender, pre-treatment AHI, and post-treatment AHI between the two groups, though there was a trend to higher age in the adherent group. CONCLUSIONS: This study demonstrated higher GAD-7 and PHQ-ADS scores in the non-adherent group compared to those who were adherent to HNS supporting that anxiety and emotional distress may contribute to HNS therapy adherence. To our knowledge, this is the first study evaluating the relationship between anxiety, depression, emotional distress, and HNS adherence. Screening patients with the GAD-7 and PHQ-9 prior to implantation may be helpful when evaluating patient adherence to therapy.

Association of Hypoglossal Nerve Stimulation With Improvements in Long-term, Patient-Reported Outcomes and Comparison With Positive Airway Pressure for Patients With Obstructive Sleep Apnea.

Importance: Hypoglossal nerve stimulation (HNS) and positive airway pressure (PAP) have been shown to improve patient-reported outcomes (PROs) in obstructive sleep apnea (OSA). However, to our knowledge, there are no data that compare change in PROs between HNS and PAP or that indicate whether HNS improves comorbid insomnia or depression in the long term. Objectives: To determine whether HNS is associated with improvements in patient-reported sleepiness, insomnia, and depression in the long term and to compare the respective associations of HNS and PAP with improved PROs. Design, Setting, and Participants: This retrospective cohort study used data from patients treated at the Cleveland Clinic for OSA. Participants received either HNS (referred sample) from November 1, 2015, to September 31, 2018, or PAP (previous cohort) from January 1, 2010, to December 31, 2014, for OSA. Patients were matched 3:1 for PAP:HNS based on age, body mass index (BMI; calculated as weight in kilograms divided by height in meters squared), sex, and apnea hypopnea index (AHI). Data were collected at baseline and at prespecified follow-up points. Data were analyzed from March 26, 2020, to September 9, 2021. Exposures: Treatment with HNS vs PAP. Main Outcomes and Measures: Data collected included AHI and Epworth Sleepiness Scale (ESS), Functional Outcomes of Sleep Questionnaire (FOSQ), Insomnia Severity Index (ISI), and Patient Health Questionnaire-9 (PHQ-9; depression) scores. Results: Among 85 patients receiving HNS (mean [SD] age, 62.8 [9.5] years; 59 men [69.4%]; 77 White patients [90.6%]; mean [SD] BMI, 28.8 [3.1]), compared with 217 matched patients receiving PAP (mean [SD] age, 62.1 [9.9] years; 157 men [72.4%]; 173 White patients [81.2%]; mean [SD] BMI, 29.5 [3.1]) included in the analysis, significant improvements were seen in PHQ-9 scores for HNS vs PAP (least square means, -4.06 [95% CI, -5.34 to -2.79] vs -2.58 [95% CI, -3.35 to -1.82]; mean difference, -1.48 [95% CI, -2.78 to -0.19]) with comparable improvements in ESS, FOSQ, and ISI scores. Clinically meaningful differences were observed in 42 of 65 HNS group patients (64.6%) vs 118 PAP group patients (54.5%) for ESS scores, 29 of 49 HNS group patients (59.2%) vs 67 of 217 PAP group patients (30.9%) for FOSQ scores, 14 of 48 HNS group patients (29.2%) vs 53 of 217 PAP group patients (24.4%) for PHQ-9 scores, and 23 of 49 HNS group patients (46.9%) vs 79 of 217 PAP group patients (36.4%) for ISI scores. At the 1-year post-HNS assessment, meaningful improvements were seen in 17 of 28 patients (60.7%) for ESS scores, 11 of 20 patients (55.0%) for FOSQ scores, 7 of 23 patients (30.4%) for PHQ-9 scores, and 11 of 25 patients (44.0%) for ISI scores. Conclusions and Relevance: In this cohort study of patients with OSA, sustained improvements in PROs were observed 1 year after HNS and were comparable to those for PAP at 3 months. These findings suggest that HNS is a viable treatment for improving insomnia and depression in patients with OSA.

Hypoglossal Nerve Stimulation Therapy for the Treatment of Obstructive Sleep Apnea.

Hypoglossal nerve stimulation (HGNS) therapy was approved in 2014 for the treatment of obstructive sleep apnea in patients who are intolerant to continuous positive airway pressure (CPAP) therapy, which is reported in up to 40-60% of patients. This therapy works via direct neurostimulation of the hypoglossal nerve in synchrony with respiration, to open the airway via tongue stiffening and protrusion. Studies have demonstrated significant reductions in both respiratory parameters such as disordered breathing indices, as well as subjective sleep complaints, such as daytime sleepiness, with the use of this therapy. This has increased the repertoire of treatment options for sleep providers to recommend to those patients that are intolerant to CPAP therapy.

Home Sleep Testing to Direct Upper Airway Stimulation Therapy Optimization for Sleep Apnea.

OBJECTIVES/HYPOTHESIS: Selective upper airway stimulation (sUAS) is a well-established treatment option for obstructive sleep apnea (OSA). This study aimed to determine if there are benefits in performing a home sleep test (HST) to evaluate postoperative sUAS effectiveness after patient acclimatization compared to the generally used polysomnography (PSG) titration, as measured by long-term follow-up outcomes. STUDY DESIGN: Retrospective comparative cohort analysis. METHODS: We conducted an analysis of consecutive patients at our center who had completed a 6-month follow-up (month 6 [M6]) and recorded data from M6, month 12 (M12), and month 24 (M24). After device activation, we performed an HST with the patient's stimulation settings, and measured the apnea-hypopnea index (AHI), Epworth Sleepiness Scale (ESS), and device usage. These values were compared to patients who had undergone PSG-based device titration. RESULTS: Baseline values of the initial 131 patients show high ESS and moderate OSA. At the 2-month time point of the HST, nearly half of the patients (46.2%) reached an AHI ≤15/hr, and approximately a fifth (19.2%) reached <5/hr. The PSG and HST groups differed in median ESS at M24, but no other differences were observed for ESS at M6 and M12. Both groups showed similar AHI, oxygen desaturation, and usage hours per week. CONCLUSIONS: Adjusting therapy by using the HST technique after device activation and acclimatization has clinical and economic advantages. These advantages are contingent on several conditions being met when deviating from the standard device protocol, including precise communication with the referring sleep medicine physicians, especially their role in helping with long-term follow-up. LEVEL OF EVIDENCE: 4 Laryngoscope, 131:E1375-E1379, 2021.

Adverse Events in Hypoglossal Nerve Stimulator Implantation: 5-Year Analysis of the FDA MAUDE Database.

OBJECTIVE: Use of hypoglossal nerve stimulator implantation has dramatically improved the surgical treatment of multilevel airway collapse during obstructive sleep apnea (OSA). Understanding causes of adverse events and their impact on patients undergoing stimulator implantation will help improve patient preparation and surgical practices to avoid future complications. STUDY DESIGN: This study is a retrospective review of the US Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database, a publicly available voluntary reporting system. SETTING: National patient event database. METHODS: The MAUDE database was searched for reports associated with the terms "hypoglossal nerve stimulator" and "Inspire," being the only currently FDA-approved system for upper airway stimulation for OSA. All records were searched with the events limited in dates between May 2014 and September 2019. RESULTS: A total of 132 patient reports were identified over the 5-year inclusion period, containing 134 adverse events. The reported adverse events resulted in 32 device revision procedures as well as 17 explantations. Device migration and infection were 2 of the most commonly reported adverse events. Complications not witnessed in previous large-scale clinical trials included pneumothorax, pleural effusion, and lead migration into the pleural space. CONCLUSION: Previous data have demonstrated hypoglossal nerve stimulator implantation results in reliable OSA improvement. However, a number of technical difficulties and complications still exist during the perioperative period, which should be communicated to patients during the surgical consent process.

Ultrasound Localization and Percutaneous Electrical Stimulation of the Hypoglossal Nerve and Ansa Cervicalis.

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 (ACST). 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 ACST 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 ACST 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.

Contralateral Tongue Muscle Activation during Hypoglossal Nerve Stimulation.

OBJECTIVE: The effectiveness of upper airway stimulation via hypoglossal nerve stimulation for obstructive sleep apnea depends upon the pattern of tongue muscle activation produced. This study investigated the nature of contralateral tongue muscle activation by unilateral hypoglossal nerve stimulation using intraoperative nerve integrity monitoring in conjunction with electromyography and explored the relationship between contralateral tongue muscle activation and polysomnographic measures of obstructive sleep apnea severity. STUDY DESIGN: Prospective case series. SETTING: Tertiary care medical center. SUBJECTS AND METHODS: Fifty-one patients underwent unilateral (right) hypoglossal nerve stimulator implantation for obstructive sleep apnea. Neurophysiological data included electromyographic responses in ipsilateral (right) and contralateral (left) genioglossus muscles in response to intraoperative bipolar probe stimulation (0.3 mA) of medial hypoglossal nerve branches. Clinical data included pre- and postoperative apnea-hypopnea indices and oxygen desaturation levels. RESULTS: A subset of patients (20/51, 39%) exhibited electromyographic responses in both the ipsilateral and contralateral genioglossus (bilateral), whereas the remaining patients (31/51, 61%) exhibited electromyographic responses only in the ipsilateral genioglossus (unilateral). The baseline characteristics of bilateral and unilateral responders were similar. Both groups exhibited significant and comparable improvements in apnea-hypopnea index and oxygen desaturations after hypoglossal nerve stimulation. Neither the amplitude nor the latency of contralateral genioglossus responses was predictive of clinical outcomes. CONCLUSION: A subset of patients undergoing unilateral hypoglossal nerve stimulation exhibits activation of contralateral genioglossus muscles. Patients with unilateral and bilateral genioglossus responses exhibit comparable, robust improvements in apnea-hypopnea index and oxygen desaturation levels.

Neurophysiological monitoring of tongue muscle activation during hypoglossal nerve stimulation.

OBJECTIVES/HYPOTHESIS: Upper airway stimulation for obstructive sleep apnea (OSA) via implantable hypoglossal nerve stimulation (HGNS) reduces airway obstruction by selectively stimulating nerve fibers that innervate muscles that produce tongue protrusion, while avoiding fibers that produce tongue retraction. This selective stimulation likely depends upon the location, intensity, and type of electrical stimulation delivered. This study investigates the impact of changing stimulation parameters on tongue muscle activation during HGNS using intraoperative nerve integrity monitoring in conjunction with electromyography (EMG). STUDY DESIGN: Prospective case series. METHODS: Ten patients undergoing unilateral HGNS implantation for OSA in a university hospital setting were studied. Data included EMG responses in tongue muscles that produce protrusion (genioglossus), retraction (styloglossus/hyoglossus), and stiffening (transverse/vertical) in response to intraoperative bipolar probe electrical stimulation of lateral and medial branches of the hypoglossal nerve (HGN) and to implantable pulse generator (IPG) unipolar and bipolar settings after placement of the stimulation cuff. RESULTS: Stimulation of medial division HGN branches resulted in EMG responses in genioglossus muscles, but not in styloglossus/hyoglossus muscles, whereas stimulation of the lateral division HGN branches drove responses in styloglossus/hyoglossus muscles. Variable responses in transverse/vertical muscles were observed with stimulation of lateral and medial division branches. After electrode cuff placement, unipolar and bipolar HGN stimulation configurations of IPG resulted in unique patterns of muscle activation. CONCLUSIONS: The relative activation of extrinsic and intrinsic tongue musculature by HGNS is determined by stimulus location, intensity, and type. Intraoperative neurophysiological monitoring of tongue muscle activation enables proper electrode cuff placement and may provide essential data for stimulus optimization. LEVEL OF EVIDENCE: 4 Laryngoscope, 130:1836-1843, 2020.

Inclusion of the first cervical nerve does not influence outcomes in upper airway stimulation for treatment of obstructive sleep apnea.

OBJECTIVES/HYPOTHESIS: Upper airway stimulation (UAS) has demonstrated efficacy in the management of obstructive sleep apnea (OSA). Branches of the hypoglossal nerve that selectively activate tongue protrusor and stiffener muscles are included within the stimulation cuff electrode. The first cervical nerve (C1) is often also included to stimulate additional muscles contributing to tongue protrusion and stabilization. The purpose of this study was to determine whether inclusion of the C1 translates into treatment efficacy, decreased voltage requirement, and improved outcomes in patients utilizing UAS. STUDY DESIGN: Single-center, retrospective cohort study. METHODS: One hundred fourteen patients who received a UAS implant at our institution and underwent posttreatment polysomnography were evaluated. Stimulation cuff electrodes in 87 patients included the C1; those in the remaining 27 patients did not include the C1. Demographic data, voltage data, and pre- and posttreatment apnea-hypopnea index (AHI), O2 nadir, and Epworth Sleepiness Scale (ESS) data were collected for all patients. RESULTS: There was no significant difference in stimulation voltage, or posttreatment AHI, O2 nadir, and ESS between the two cohorts. Treatment success, as measured by posttreatment AHI < 20 with a 50% reduction, was similar regardless of C1 inclusion. The same was seen for the percent of patients with AHI < 15 and AHI < 5 after treatment. The distributions of age and body mass index, as well as pre-treatment AHI, O2 nadir, and ESS were also not significantly different between treatment groups. CONCLUSIONS: The current study has demonstrated that inclusion of the C1 in the stimulation cuff electrode of the upper airway stimulator may not provide any additional benefit in therapy for OSA. LEVEL OF EVIDENCE: 4 Laryngoscope, 130:E382-E385, 2020.

[Hypoglossal nerve stimulation for obstructive sleep apnoea; technique, indication and future prospects]. / Stimulatie van tongzenuw bij obstructieve slaapapneu.

Hypoglossal nerve stimulation for obstructive sleep apnoea; technique, indication and future prospects Continuous positive airway pressure (CPAP) is the treatment of first choice in patients with moderate to severe obstructive sleep apnoea (OSA); however, 1 in 3 patients does not tolerate CPAP. Upper airway stimulation (UAS) is an alternative for CPAP. This is a new treatment, intended for patients with CPAP intolerance or failure. The muscles responsible for protrusion of the tongue are activated by unilateral stimulation of the hypoglossal nerve, resulting in opening up of the pharynx. Since April 2017, UAS treatment has been reimbursed for a select group of patients by the National Healthcare Institute in the Netherlands, leading to an increase in demand for UAS.

Patient experience with upper airway stimulation in the treatment of obstructive sleep apnea.

OBJECTIVE: Selective upper airway stimulation (sUAS) is a new treatment modality for patients with obstructive sleep apnea (OSA) and continuous positive airway pressure (CPAP) failure. The aim of this study was to analyze therapy adherence and to structure patient experience reports. METHODS: Patients from two German implantation centers were included. Besides demographic and OSA characteristics of that cohort, patients answered a questionnaire on subjective sensation of the stimulation, use of different functions, side effects, and an inventory for the description of the attitude towards sUAS. The use of the sUAS was evaluated as a read-out of the implanted system. RESULTS: The overall apnea-hypopnea-index (AHI) of that 102 assessed patients reduced from initially 32.8/h to 12.6/h at the last available assessment. The responder rate was 75%. There was an objective therapy usage of 5.7 h and subjective reports of 6.8 nights per week. The attitude resulted in strong agreement towards the statement "UAS reduces the problems caused by my sleep apnea". Information on sensing the stimulation and usage habits could be gathered such as that stimulation is only sensed by 67.9% of the patients upon waking in the morning and that 73.6% of the patients do not change the voltage in general. CONCLUSION: This investigation on the sUAS therapy revealed a high adherence to the therapy. The AHI or daytime sleepiness do not have obvious influence on adherence. Patients expressed a positive attitude towards sUAS. These patient reports upon stimulation experiences are of great help to consult candidates for sUAS in future.

Selective upper airway stimulation in older patients.

OBJECTIVE: Selective stimulation of the hypoglossal nerve has proven to be an effective therapy for patients with obstructive sleep apnea (OSA). The aim of the study is to investigate the efficacy of selective upper airway stimulation (sUAS) in older adults. METHODS: All consecutive patients older than 64 years and who received an implant for sUAS were enrolled. As a control group, an equal number of patients younger than 65 years with matched apnea hypopnea index (AHI) and body-mass-index (BMI) were selected. Treatment outcome data were collected including daytime sleepiness as well as demographics with co-morbidities, BMI, adverse events and adherence to therapy. RESULTS: 62 patients were included. Both the control and study group did not differ significantly for AHI, BMI, and Epworth Sleepiness Scale (ESS) (28.7-28.4/h; 30.1 to 28.4 kg/m2; 14.6 to 12.0 points); but co-morbidities were significantly higher in the study group. Our data showed no significant difference between the outcomes of study and control group for AHI, Oxygen desaturation index (ODI) and ESS (6.0-6.0/h; 7.9 to 5.5/h; 5.0 to 7.0 points). Serious adverse events did not occur in both groups and surgical implantation time did not differ. CONCLUSION: sUAS leads to significant reductions of AHI, ODI and ESS in older patients. Despite higher age and more co-morbidities, surgical implantation time was not affected. Older patients showed higher usage of sUAS. Advanced age seems not to be a limiting factor for treatment outcomes of sUAS, thus indication for this treatment can also be applied to older people.

Early feasibility of hypoglossal nerve upper airway stimulator in patients with cardiac implantable electronic devices and continuous positive airway pressure-intolerant severe obstructive sleep apnea.

BACKGROUND: Implantable hypoglossal nerve upper airway stimulation (HNS) is a novel strategy approved by the US Food and Drug Administration for the management of moderate-to-severe obstructive sleep apnea (OSA) in patients with continuous positive airway pressure therapy intolerance or failure. Because of the proximity of a cardiac implantable electronic device (CIED) to this stimulator, interaction between these devices is theoretically possible. OBJECTIVE: The purpose of this study was to assess interactions between an implantable HNS device and a CIED. METHODS: We retrospectively analyzed 14 ad hoc patients with continuous positive airway pressure-intolerant, moderate-to-severe OSA and pre-existing transvenous CIEDs undergoing HNS implantation (Inspire II, Inspire Medical Systems). We assessed these devices for their pre and postimplant OSA outcomes and for possible device-device interaction. All patients were followed up for 1 year. RESULTS: Of the 14 patients, 9 had a pacemaker (8 dual-chamber, 1 single-chamber), 4 had an implantable cardioverter-defibrillator (2 dual-chamber, 1 single-chamber), and 1 had a cardiac resynchronization therapy device. All the HNS devices were implanted on the opposite side of the CIED. All CIEDs were programmed bipolar. HNS were programmed either unipolar or bipolar. During implant, intraoperative testing was performed to confirm that bipolar and unipolar HNS stimulation did not impact CIED sensing. During the follow-up period, no oversensing episodes were noted on the CIEDs. CONCLUSION: In this early experience, simultaneous use of a novel hypoglossal nerve upper airway stimulation device with transvenous CIEDs seems to be safe, effective, and without any device-device interactions.

Technical tips during implantation of selective upper airway stimulation.

OBJECTIVE: Selective upper airway stimulation is now well-established in the United States and in several European countries, with more than 1,000 patients implanted since U.S. Food and Drug Administration approval in April 2014. The authors herein, all head and neck surgeons, account for approximately one of every five implants completed to date. Several of the authors also provide comprehensive longitudinal care of their patients as dual-specialty sleep medicine physicians. STUDY DESIGN: Multi-center, retrospective clinical analysis. METHODS: More than 300 implants have been evaluated and reviewed in five different implant centers (Germany, United States). RESULTS: This analysis shares tips and techniques from the collective experiences with more than 300 implants, which can help newer implanters learn vicariously both for standard practices in executing routine implants through activation and, importantly, for working through more challenging encounters with anatomy, special patient phenotypes, system testing, and troubleshooting. CONCLUSION: These tips should help new implanters handle most of the situations arising during implantation and avoid common pitfalls. Laryngoscope, 128:756-762, 2018.

Tongue motion variability with changes of upper airway stimulation electrode configuration and effects on treatment outcomes.

OBJECTIVES/HYPOTHESIS: Upper airway stimulation (UAS) is an effective treatment for obstructive sleep apnea (OSA). Previous data have demonstrated a correlation between the phenotype of tongue motion and therapy response. Closed loop hypoglossal nerve stimulation implant offers five different electrode configuration settings which may result in different tongue motion. STUDY DESIGN: Two-center, prospective consecutive trial in a university hospital setting. METHODS: Clinical outcomes of 35 patients were analyzed after at least 12 months of device use. Tongue motion was assessed at various electrode configuration settings. Correlation between the tongue motion and treatment response was evaluated. RESULTS: OSA severity was significantly reduced with the use of UAS therapy (P < .001). Changes in tongue motion patterns were frequently observed (58.8%) with different electrode configuration settings. Most of the patients alternated between right and bilateral protrusion (73.5%), which are considered to be the optimal phenotypes for selective UAS responses. Different voltage settings were required to achieve functional stimulation levels when changing between the electrode settings. CONCLUSIONS: UAS is highly effective for OSA treatment in selected patients with an apnea-hypopnea index between 15 and 65 events per hour and higher body mass index. Attention should be given to patients with shifting tongue movement in response to change of electrode configuration. The intraoperative cuff placement should be reassessed when tongue movement shifting is observed. LEVEL OF EVIDENCE: 4 Laryngoscope, 1970-1976, 2018.

Voice and swallowing outcomes following hypoglossal nerve stimulation for obstructive sleep apnea.

OBJECTIVE: Hypoglossal nerve stimulation is an effective treatment for a subset of patients with Obstructive Sleep Apnea (OSA). Although multiple clinical trials demonstrate its efficacy, no previous literature explores the potential impact the stimulator has on swallowing and voice. Our primary objective is to evaluate patient reported post-operative changes in voice or swallowing following hypoglossal nerve stimulator placement. STUDY DESIGN: Prospective cohort study. SETTING: Tertiary care hospital. SUBJECT AND METHODS: Patients scheduled to receive a hypoglossal stimulator were enrolled. Participants completed baseline Voice Handicap Index-10 (VHI-10) and Eating Assessment Tool-10 (EAT-10) questionnaires preoperatively and again at 1week, 3months, and 6months post-operatively following placement of a hypoglossal nerve stimulator. RESULTS: 9 males and 5 females completed the study. The mean pre-operative VHI-10 and EAT-10 score was 3 and 0.8 respectively. Using linear mixed models, a clinically and statistically significant increase in the mean EAT-10 score was observed post-operatively at 1week (p=0.007), which was not observed at the time points the stimulator was active. A clinically and statistically significant decrease in VHI-10 score was observed following 2months of active stimulator use (p=0.02), which was not observed at any other time point. CONCLUSION: The implantation and use of the hypoglossal nerve stimulator over 5months did not demonstrate any sustained, patient reported changes in voice handicap and swallowing function. While larger studies are warranted, our findings can be used to provide further informed consent for hypoglossal nerve stimulator implantation.