Upper Airway Stimulation for Obstructive Sleep Apnea: Self-Reported Outcomes at 24 Months

Abstract

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...

Upper Airway Stimulation for Treatment of Obstructive Sleep Apnea: An Evaluation and Comparison of Outcomes at Two Academic Centers

“…Additional studies of the STAR cohort showed maintenance of these outcomes at 18, 24, and 36 months. [6][7][8][9] Two case series with chart reviews have been published since, with smaller cohorts of patients that have been consistent with the results seen in the STAR trials. Kent et al 10 reviewed their series of 20 patients and found improvement in postoperative AHI and ESS from 33.3 to 5.1 and 10.3 to 6 respectively.…”

Phenotypes in obstructive sleep apnea: A definition, examples and evolution of approaches

“…For example, complete concentric collapse of the palate in OSA patients predicts failure to respond to upper airway neuro-stimulation therapy [24]. Although the biological underpinnings of this OSA feature are not fully understood, meaningful benefits can accrue from using this phenotype to augment clinical trial design [15] and patient care [25]. The definition also provides a basis for deeper characterization of physiological or molecular mechanistic investigations.…”

Insights since FDA Approval of Hypoglossal Nerve Stimulation for the Treatment of Obstructive Sleep Apnea

“…The Inspire-sponsored FDA Phase III Stimulation Therapy for Apnea Reduction (the STAR trial) has to date the most information on outcomes with this therapy: safety and efficacy 19–21 . The STAR trial was a prospective cohort study which enrolled 126 CPAP-intolerant OSA patients, all of whom had activation of the therapy about 1 month after implantation.…”

“…There is probably a need a PSG sometime after implant (1–2 months) to examine the effect of stimulation on event type in all positions and in all stages of sleep, as well as to show improvements in oxygen saturation and heart rate by sleep state. However, management at follow-up can be managed by home sleep testing, portable studies of cardiopulmonary function over time without sleep, as shown in post-approval studies 19, 53 .…”