Objective To present 5-year outcomes from a prospective cohort of patients with obstructive sleep apnea (OSA) who were treated with upper airway stimulation (UAS) via a unilateral hypoglossal nerve implant. Study Design A multicenter prospective cohort study. Setting Industry-supported multicenter academic and clinical trial. Methods From a cohort of 126 patients, 97 completed protocol, and 71 consented to a voluntary polysomnogram. Those having continuous positive airway pressure failure with moderate to severe OSA, body mass index <32 kg/m, and no unfavorable collapse on drug-induced sleep endoscopy were enrolled in a phase 3 trial. Prospective outcomes included apnea-hypopnea index (AHI), oxygen desaturation index, and adverse events, as well as measures of sleepiness, quality of life, and snoring. Results Patients who did and did not complete the protocol differed in baseline AHI, oxygen desaturation index, and Functional Outcomes of Sleep Questionnaire scores but not in any other demographics or treatment response measures. Improvement in sleepiness (Epworth Sleepiness Scale) and quality of life was observed, with normalization of scores increasing from 33% to 78% and 15% to 67%, respectively. AHI response rate (AHI <20 events per hour and >50% reduction) was 75% (n = 71). When a last observation carried forward analysis was applied, the responder rate was 63% at 5 years. Serious device-related events all related to lead/device adjustments were reported in 6% of patients. Conclusions Improvements in sleepiness, quality of life, and respiratory outcomes are observed with 5 years of UAS. Serious adverse events are uncommon. UAS is a nonanatomic surgical treatment with long-term benefit for individuals with moderate to severe OSA who have failed nasal continuous positive airway pressure.

Objectives/Hypothesis:Previous feasibility studies have shown that electrical stimulation of the hypoglossal nerve can improve obstructive sleep apnea (OSA). The current study examined the safety and preliminary effectiveness of a second generation device, the Upper Airway Stimulation (UAS) system, and identified baseline predictors for therapy success.Study Design:Two consecutive open prospective studies.Methods:UAS systems were implanted in patients with moderate to severe OSA who failed or were intolerant of continuous positive airway pressure (CPAP). The study was conducted in 2 parts. In part 1, patients were enrolled with broad selection criteria. Apnea hypopnea index (AHI) was collected using laboratory‐based polysomnography at preimplant and postimplant visits. Epworth Sleepiness Scale (ESS) and Functional Outcomes of Sleep Questionnaire (FOSQ) were also collected. In part 2, patients were enrolled using selection criteria derived from the experience in part 1.Results:In part 1, 20 of 22 enrolled patients (two exited the study) were examined for factors predictive of therapy response. Responders had both a body mass index ≤32 and AHI ≤50 (P < .05) and did not have complete concentric palatal collapse. Part 2 patients (n = 8) were selected using responder criteria and showed an improvement on AHI from baseline, from 38.9 ± 9.8 to 10.0 ± 11.0 (P < .01) at 6 months postimplant. Both ESS and FOSQ improved significantly in part 1 and 2 subjects.Conclusions:The current study has demonstrated that therapy with upper airway stimulation is safe and efficacious in a select group of patients with moderate to severe OSA who cannot or will not use CPAP as primary treatment. Laryngoscope, 2012

The ESP may offer benefits in a selected group of OSA patients.

The pathophysiologic events that lead to the loss of airway compensation in obstructive sleep apnea (OSA) are poorly understood. The development of airway instability may be secondary to changes in neurologic control, airway morphology, or both. To identify potential histopathologic features of pharyngeal tissues that may contribute to OSA, transverse sections of the distal soft palate and uvula were qualitatively compared using light and electron microscopy from 4 severe apneics (>50 apnea/hour), 4 severe snorers (<20 apnea/hour), and 4 nonsnorers. Light microscopy of both apneics and snorers revealed mucous gland hypertrophy with ductal dilation and focal squamous metaplasia, disruption of muscle bundles by infiltrating mucous glands, focal atrophy of muscle fibers, and extensive edema of the lamina propria with vascular dilation. Severe snorers did not differ qualitatively from apneics in the characteristic changes found; however, some snorers had less extensive changes. No distinctive histopathologic findings could be associated with the development of apnea. Electron microscopy of severe apneics identified frequent focal degeneration of myelinated nerve fibers and axons. The finding of similar histopathologic changes in apneics and severe snorers supports previous speculation of a common etiology not directly related to apnea, such as vibratory trauma to pharyngeal tissues. Degenerative changes in peripheral nerves, identified on electron microscopy, however, may contribute to airway instability and the development of obstructive apnea by impairing pharyngeal reflexes.

Objectives:To evaluate the long-term (24-mo) effect of cranial nerve upper airway stimulation (UAS) therapy on patient-centered obstructive sleep apnea (OSA) outcome measures. Methods: Prospective, multicenter, cohort study of 126 patients with moderate to severe OSA who had difficulty adhering to positive pressure therapy and received the surgically implanted UAS system. Outcomes were measured at baseline and postoperatively at 12 mo and 24 mo, and included self-and bedpartner-report of snoring intensity, Epworth Sleepiness Scale (ESS), and Functional Outcomes of Sleep Questionnaire (FOSQ). Additional analysis included FOSQ subscales, FOSQ-10, and treatment effect size. Results: Significant improvement in mean FOSQ score was observed from baseline (14.3) to 12 mo (17.3), and the effect was maintained at 24 mo (17.2). Similar improvements and maintenance of effect were seen with all FOSQ subscales and FOSQ-10. Subjective daytime sleepiness, as measured by mean ESS, improved significantly from baseline (11.6) to 12 mo (7.0) and 24 mo (7.1). Self-reported snoring severity showed increased percentage of "no" or "soft" snoring from 22% at baseline to 88% at 12 mo and 91% at 24 mo. UAS demonstrated large effect size (> 0.8) at 12 and 24 mo for overall ESS and FOSQ measures, and the effect size compared favorably to previously published effect size with other sleep apnea treatments. Conclusions: In a selected group of patients with moderate to severe OSA and body mass index ≤ 32 kg/m2, hypoglossal cranial nerve stimulation therapy can provide significant improvement in important sleep related quality-of-life outcome measures and the effect is maintained across a 2-y follow-up period. I NTRO DUCTI O NPatients suffering from moderate to severe obstructive sleep apnea (OSA) commonly report symptoms consistent with excessive daytime sleepiness, neurocognitive dysfunction, and impaired quality of life.1 Although the underlying pathophysiologic mechanisms of OSA are complex, multifactorial, and variable among patients, the goals of any longitudinal care model are generally consistent across all patients and fall into two categories: (1) to improve sleep related symptoms and quality-of-life measures, and (2) to reduce cardiovascular and related health risks.Continuous positive airway pressure (CPAP) therapy has a wealth of data on safely and effectively accomplishing these goals and remains the standard first-line therapy.2,3 Despite the low morbidity and high effectiveness of CPAP, long-term adherence and acceptance rates are suboptimal and necessitate consideration of alternative treatment options in many patients. adequate use. Recent multicenter trials reported 6-mo adherence rates of only 39% to 50%. 5,6 A universally accepted second-line therapy does not exist; however, oral appliance BRIEF SUMMARY Current Knowledge/Study Rationale: Hypoglossal cranial nerve stimulation therapy consists of a surgically implantable and medically titratable second-line treatment option for obstructive sleep apnea (OSA), and was previous...

In mild obstructive sleep apnea, treatment of symptomatic outcomes with RFTVR may be an alternative to CPAP.

Palate implants for mild to moderate obstructive sleep apnea demonstrated efficacy over placebo for several important outcomes measures with minimal morbidity, but overall effectiveness remains limited. Further study is needed.

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.