Ryan J. Soose

Three-Year Outcomes of Cranial Nerve Stimulation for Obstructive Sleep Apnea The STAR Trial

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

Randomized Controlled Withdrawal Study of Upper Airway Stimulation on OSA: Short- and Long-term Effect

Objective To assess the efficacy and durability of upper airway stimulation via the hypoglossal nerve on obstructive sleep apnea (OSA) severity including objective and subjective clinical outcome measures. Study Design A randomized controlled therapy withdrawal study. Setting Industry-supported multicenter academic and clinical setting. Subjects A consecutive cohort of 46 responders at 12 months from a prospective phase III trial of 126 implanted participants. Methods Participants were randomized to either therapy maintenance (“ON”) group or therapy withdrawal (“OFF”) group for a minimum of 1 week. Short-term withdrawal effect as well as durability at 18 months of primary (apnea hypopnea index and oxygen desaturation index) and secondary outcomes (arousal index, oxygen desaturation metrics, Epworth Sleepiness Scale, Functional Outcomes of Sleep Questionnaire, snoring, and blood pressure) were assessed. Results Both therapy withdrawal group and maintenance group demonstrated significant improvements in outcomes at 12 months compared to study baseline. In the randomized assessment, therapy withdrawal group returned to baseline, and therapy maintenance group demonstrated no change. At 18 months with therapy on in both groups, all objective respiratory and subjective outcome measures showed sustained improvement similar to those observed at 12 months. Conclusion Withdrawal of therapeutic upper airway stimulation results in worsening of both objective and subjective measures of sleep and breathing, which when resumed results in sustained effect at 18 months. Reduction of obstructive sleep apnea severity and improvement of quality of life were attributed directly to the effects of the electrical stimulation of the hypoglossal nerve.

Upper Airway Stimulation for Obstructive Sleep Apnea: Durability of the Treatment Effect at 18 Months.

OBJECTIVE To determine the stability of improvement in polysomnographic measures of sleep disordered breathing, patient reported outcomes, the durability of hypoglossal nerve recruitment and safety at 18 months in the Stimulation Treatment for Apnea Reduction (STAR) trial participants. DESIGN Prospective multicenter single group trial with participants serving as their own controls. SETTING Twenty-two community and academic sleep medicine and otolaryngology practices. MEASUREMENTS Primary outcome measures were the apnea-hypopnea index (AHI) and the 4% oxygen desaturation index (ODI). Secondary outcome measures were the Epworth Sleepiness Scale (ESS), the Functional Outcomes of Sleep Questionnaire (FOSQ), and oxygen saturation percent time < 90% during sleep. Stimulation level for each participant was collected at three predefined thresholds during awake testing. Procedure- and/or device-related adverse events were reviewed and coded by the Clinical Events Committee. RESULTS The median AHI was reduced by 67.4% from the baseline of 29.3 to 9.7/h at 18 mo. The median ODI was reduced by 67.5% from 25.4 to 8.6/h at 18 mo. The FOSQ and ESS improved significantly at 18 mo compared to baseline values. The functional threshold was unchanged from baseline at 18 mo. Two participants experienced a serious device-related adverse event requiring neurostimulator repositioning and fixation. No tongue weakness reported at 18 mo. CONCLUSION Upper airway stimulation via the hypoglossal nerve maintained a durable effect of improving airway stability during sleep and improved patient reported outcomes (Epworth Sleepiness Scale and Functional Outcomes of Sleep Questionnaire) without an increase of the stimulation thresholds or tongue injury at 18 mo of follow-up.

Upper Airway Stimulation for OSA Early Adherence and Outcome Results of One Center

Objective To review outcome measures and objective adherence data for patients treated with hypoglossal nerve stimulation (HNS) therapy for moderate to severe obstructive sleep apnea (OSA). Study Design Case series with chart review. Setting Academic sleep medicine center. Subjects and Methods The first 20 implanted patients to complete postoperative sleep laboratory testing were assessed. All patients had moderate to severe OSA, were unable to adhere to positive pressure therapy, and met previously published inclusion criteria for the commercially available implantable HNS system. Data included demographics, body mass index (BMI), apnea-hypopnea index (AHI), Epworth Sleepiness Score (ESS), nightly hours of device usage, and procedure- and therapy-related complications. Results Mean age was 64.8 ± 12.0 years, with 50% female. Mean BMI was unchanged postoperatively (26.5 ± 4.2 to 26.8 ± 4.5 kg/m2; P > .05). Mean AHI (33.3 ± 13.0 to 5.1 ± 4.3; P < .0001) and mean ESS (10.3 ± 5.2 to 6.0 ± 4.4; P < .01) decreased significantly. Seventy percent (14/20) of patients achieved a treatment AHI <5, 85% (17/20) an AHI <10, and 95% (19/20) an AHI <15. Average stimulation amplitude was 1.89 ± 0.50 V after titration. Adherence monitoring via device interrogation showed high rates of voluntary device use (mean 7.0 ± 2.2 h/night). Conclusion For a clinical and anatomical subset of patients with OSA, HNS therapy is associated with good objective adherence, low morbidity, and improved OSA outcome measures. Early results at one institution suggest that HNS therapy can be implemented successfully into routine clinical practice, outside of a trial setting.

Updates of operative techniques for upper airway stimulation.

Selective upper airway stimulation has been established as an additional treatment for obstructive sleep apnea (OSA). Essential for the treatment is the precise placement of the cuff electrode for select branches of the hypoglossal nerve, which innervate the protrusors and stiffeners of the tongue. A direct approach to the distal hypoglossal nerve has been established to achieve this goal. For surgeons, detailed knowledge of this anatomy is vital. Another decisive step is the placement of the sensing lead between the intercostal muscles. Also, the complexity of follow‐up care postoperatively should be kept in mind. The aim of this article is to provide the latest knowledge on the neuroanatomy of the hypoglossal nerve and to give surgeons a step‐by‐step guide on the current operative technique. Laryngoscope, 126:S12–S16, 2016

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

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

Efficacy of Upper Airway Stimulation on Collapse Patterns Observed during Drug-Induced Sedation Endoscopy

Objective To describe upper airway collapse patterns observed on drug-induced sedation endoscopy (DISE) during screening for a clinical trial and to evaluate the impact of collapse patterns found on preoperative DISE on response rates to upper airway stimulation (UAS) therapy. Study Design Retrospective review of an ongoing prospective multi-institutional cohort study. Setting Twenty-two participating institutions of the STAR trial. Subjects and Method In total, 222 subjects were screened with DISE to determine eligibility for an implantable UAS device. Supine laryngoscopy was performed during moderate sedation (propofol and/or midazolam). Airway collapse pattern and severity were graded at 4 levels, including velum, oropharynx, tongue base, and epiglottis (VOTE classification). Patients with complete concentric collapse (CCC) at the velum were excluded from implantation. Results The CCC at the velum was observed in 52 (23%) of screened subjects, and these subjects were subsequently excluded from implantation. Of the 170 subjects without CCC at the velum, 126 (77%) underwent implantation: 121 (96%) had multilevel collapse and 5 (4%) had single-level collapse. When comparing preimplantation DISE findings, UAS responders at 12 months had lower baseline VOTE scores compared with therapy nonresponders. Conclusion Drug-induced sedation endoscopy is an efficient and safe method for determining UAS eligibility and has the potential to identify UAS nonresponders. Most patients had multilevel airway collapse, illustrating the limitations of single-level upper airway surgery in treating obstructive sleep apnea. Upper airway stimulation is effective therapy for most patients with multilevel airway collapse; however, patients with complete anterior-posterior or lateral soft palate and/or epiglottic collapse may be at increased risk of therapy failure.

Drug-Induced Sedation Endoscopy in the Evaluation of OSA Patients with Incomplete Oral Appliance Therapy Response.

Objective To use drug-induced sedation endoscopy (DISE) to identify locations and patterns of residual collapse in patients with obstructive sleep apnea (OSA) with incomplete response to oral appliance therapy (OAT). Study Design Case series with chart review. Setting Academic multidisciplinary sleep practice. Subjects and Methods Thirty-five consecutively screened adult patients with OSA with continuous positive airway pressure (CPAP) intolerance and incomplete response to OAT (apnea-hypopnea index [AHI] >15 or AHI >5 with persistent subjective symptoms) who underwent DISE with and without the oral appliance. Data collected included demographics, body mass index, polysomnography data, and management decisions after DISE. Each DISE video pair was retrospectively scored using the VOTE classification system by the same blinded reviewer (R.J.S.). Results All patients had multilevel airway collapse at baseline. The palate was the most common location of OAT failure. Fifteen (42.9%) had persistent collapse of the velum during DISE with OAT, and 7 (20%) had persistent collapse of the epiglottis. Twenty-three (65.7%) patients were offered targeted surgery based on DISE findings to augment OAT effectiveness. Twenty (57.1%) patients underwent additional medical therapy such as OAT adjustment or cervical positional therapy. Mean AHI was reduced from 37.4 at baseline, to 16.4 with OAT (P < .01), and to 10.7 after post-DISE intervention (P < .78). Conclusion In patients with incomplete response to OAT, DISE with and without the appliance can identify residual anatomical locations of collapse, which may direct additional medical and surgical treatment options to augment OAT effectiveness. Further work is needed to determine if DISE affects outcomes.

What is the role of the larynx in adult obstructive sleep apnea

To examine the current body of literature supporting the role of the larynx in adult obstructive sleep apnea (OSA).

Hypoglossal Nerve Stimulator Implantation in an Adolescent With Down Syndrome and Sleep Apnea

Obstructive sleep apnea (OSA) is more common in children with Down syndrome, affecting up to 60% of patients, and may persist in up to 50% of patients after adenotonsillectomy. These children with persistent moderate to severe OSA require continuous positive airway pressure, which is often poorly tolerated, or even tracheotomy for severe cases. The hypoglossal nerve stimulator is an implantable device that produces an electrical impulse to the anterior branches of the hypoglossal nerve, resulting in tongue protrusion in response to respiratory variation. It is an effective treatment of sleep apnea in select adult patients because it allows for alleviation of tongue base collapse, improving airway obstruction. Herein we describe the first pediatric hypoglossal nerve stimulator implantation, which was performed in an adolescent with Down syndrome and refractory severe OSA (apnea hypopnea index [AHI]: 48.5 events/hour). The patient would not tolerate continuous positive airway pressure and required a long-standing tracheotomy. Hypoglossal nerve stimulator therapy was well tolerated and effective, resulting in significant improvement in the patient’s OSA (overall AHI: 3.4 events/hour; AHI: 2.5–9.7 events/hour at optimal voltage settings depending on sleep stage and body position). Five months after implantation, the patient’s tracheotomy was successfully removed and he continues to do well with nightly therapy.