In this uncontrolled cohort study, upper-airway stimulation led to significant improvements in objective and subjective measurements of the severity of obstructive sleep apnea. (Funded by Inspire Medical Systems; STAR ClinicalTrials.gov number, NCT01161420.).

No abstract

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.

Methods: The authors have evaluated all the available evidence reported in the literature and have compared experience among various departments in leading European centers in order to provide a standardization of the DISE procedure and an in-depth insight in the main aspects of this technique.Background: Although drug-induced sedation endoscopy (DISE) represents the most widespread diagnostic tool for upper airway endoscopic evaluation of snoring and obstructive sleep apnea hypopnea syndrome (OSAHS), many controversies exist about how to perform the sedation, the indications for DISE, and how to report DISE findings. The present position paper reports on a consensus as proposed by a group of European experts in the field of DISE after discussion during a recent dedicated meeting.Results: A proposal of the DISE procedure standardization has been achieved with a general agreement concerning the terminology, indications, contraindications, required preliminary examinations, setting, technical equipment required, staffing, local anesthesia and nasal decongestion, patient positioning, basis and special diagnostic maneuvers, and the applied sedation drugs and observation windows. Otherwise, no consensus has been reached on a scoring and classification system.Conclusions: Although consensus has been reached on several aspects of the DISE procedure, some topics remain open to future research, such as a better analysis of the importance of positional aspects during DISE and a further comparison of the differences in degree, level and pattern of upper airway collapse observed during DISE versus during natural sleep and awake endoscopy. Finally, a universally accepted scoring and classification system is lacking

No abstract

O bstructive sleep apnea (OSA) is a common disorder that affects sleep and quality of life. Because many people with OSA cannot or will not comply with the standard treatment with a continuous positive airway pressure (CPAP) mask, alternative treatments have been sought. Upper-airway stimulation using unilateral stimulation of the hypoglossal nerve is a possible option. This multicenter, prospective, single-group, cohort trial and a follow-up randomized therapy-withdrawal trial were performed to evaluate the clinical safety and effectiveness of upper-airway stimulation for treating moderate to severe OSA.Patients who had difficulty accepting or adhering to CPAP treatment were included and served as their own controls. After initial screening, including polysomnography, qualified patients underwent surgery to implant the upper-airway stimulation system in which a stimulation electrode was placed on the hypoglossal nerve to recruit tongue-protrusion function. The sensing lead was placed between the internal and external intercostal muscles to detect ventilatory effort, and the neurostimulator was implanted in the right ipsilateral midinfraclavicular region. A month after implantation, patients had a second baseline diagnostic polysomnographic exam before the device was activated. Patients used a controller to initiate and stop therapy each night and then were assessed at 2, 3, 6, 9, and 12 months. The primary outcome was the change in the severity of OSA as determined by the apneahypopnea index (AHI; number of apnea or hypopnea events per hour; score ≥15 indicates moderate to severe OSA) and the O 2 desaturation index (ODI; number of times per hour of sleep that the blood O 2 level drops by ≥4 percentage points from baseline). At the 12-month assessment, a response to treatment was defined as an AHI reduction of 50% or greater from baseline and a score of less than 20 events per hour along with an ODI reduction of 25% or greater from baseline. The primary efficacy objectives were response rates of 50% or greater as assessed in the AHI and ODI. Secondary outcomes were the Epworth Sleepiness Scale, the Functional Outcomes of Sleep Questionnaire (FOSQ), and the percentage of sleep time with the O 2 saturation of less than 90%. Consecutive patients with a response were included in a randomized controlled therapywithdrawal trial in which they were assigned in a 1:1 ratio to either the therapy-maintenance or therapy-withdrawal group. The withdrawal group had the device turned off for 7 days; the maintenance group continued using the device. Polysomnography was done to measure the effects of withdrawal compared with continued use of therapy. Serious adverse events were those that led to death, lifethreatening illness, permanent impairment, or new or prolonged hospitalization with serious health impairment.Of the 126 participants, 83% were men; mean age was 54.5 years, and mean body mass index was 28.4 kg/m 2 . The mean AHI score on the initial screening polysomnography was 32.0 events per hour, and the mean ODI score was ...

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

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.