Analysis of Recent Sleep Surgery Fellowship Training.

OBJECTIVE: Since 2011, otolaryngologists aiming to become certified in sleep medicine have had to complete an ACGME accredited sleep medicine fellowship. In addition to standard sleep medicine and sleep surgery fellowships, several institutions have developed hybrid ACGME sleep medicine programs that incorporate sleep surgery training. Our primary aims were to understand the balance between sleep medicine and surgical training requirements and the surgical volume of recent graduates across the three pathways. Our secondary aim was to assess their employment post-graduation. An improved understanding of the current state of sleep surgeon training could better inform both applicants and programs and be used to guide fellowship curriculum development. METHODS: Between 2017 and 2023, we identified 26 surgeons who completed a sleep focused fellowship. An anonymous survey was developed and emailed to them. The survey assessed clinic and operating balance, procedures completed during fellowship, and comfort with these procedures as attendings. Finally, the survey assessed the job prospects of graduates. Data were analyzed with Prism 10. RESULTS: There were 19 respondents with 52.6% completing a hybrid fellowship, 21.3% completing a sleep medicine fellowship, and 31.6% completing a sleep surgery fellowship. Approximately 84.8% completed ACGME accredited otolaryngology training prior to fellowship. The three most common surgeries were hypoglossal nerve stimulators, pharyngoplasty, and nasal surgeries. Respondents on average received 2.4 job offers, 55% returned to their residency institution, and 89.5% were in academics. CONCLUSION: Our survey demonstrates a wide variability in sleep-focused fellowships for surgeons, but the employment market for these trainees is robust. LEVEL OF EVIDENCE: N/A Laryngoscope, 2024.

Hypoglossal Nerve Stimulation and Cardiovascular Outcomes for Patients With Obstructive Sleep Apnea: A Randomized Clinical Trial.

Importance: Sham-controlled trials are needed to characterize the effect of hypoglossal nerve stimulation (HGNS) therapy on cardiovascular end points in patients with moderate-severe obstructive sleep apnea (OSA). Objective: To determine the effect of therapeutic levels of HGNS, compared to sham levels, on blood pressure, sympathetic activity, and vascular function. Design, Setting, and Participants: This double-blind, sham-controlled, randomized crossover therapy trial was conducted from 2018 to 2022 at 3 separate academic medical centers. Adult patients with OSA who already had an HGNS device implanted and were adherent and clinically optimized to HGNS therapy were included. Participants who had fallen asleep while driving within 1 year prior to HGNS implantation were excluded from the trial. Data analysis was performed from January to September 2022. Interventions: Participants underwent a 4-week period of active HGNS therapy and a 4-week period of sham HGNS therapy in a randomized order. Each 4-week period concluded with collection of 24-hour ambulatory blood pressure monitoring (ABPM), pre-ejection period (PEP), and flow-mediated dilation (FMD) values. Main Outcomes and Measures: The change in mean 24-hour systolic blood pressure was the primary outcome, with other ABPM end points exploratory, and PEP and FMD were cosecondary end points. Results: Participants (n = 60) were older (mean [SD] age, 67.3 [9.9] years), overweight (mean [SD] body mass index, calculated as weight in kilograms divided by height in meters squared, 28.7 [4.6]), predominantly male (38 [63%]), and had severe OSA at baseline (mean [SD] apnea-hypopnea index, 33.1 [14.9] events/h). There were no differences observed between active and sham therapy in 24-hour systolic blood pressure (mean change on active therapy, -0.18 [95% CI, -2.21 to 1.84] mm Hg), PEP (mean change on active therapy, 0.11 [95% CI, -5.43 to 5.66] milliseconds), or FMD (mean change on active therapy, -0.17% [95% CI, -1.88% to 1.54%]). Larger differences between active and sham therapy were observed in a per-protocol analysis set (n = 20) defined as experiencing at least a 50% reduction in apnea-hypopnea index between sham and active treatment. Conclusions and Relevance: In this sham-controlled HGNS randomized clinical trial, mean 24-hour systolic blood pressure and other cardiovascular measures were not significantly different between sham and active HGNS therapy. Several methodologic lessons can be gleaned to inform future HGNS randomized clinical trials. Trial Registration: ClinicalTrials.gov Identifier: NCT03359096.

Long-Term Generator Replacement Experience in Hypoglossal Nerve Stimulator Therapy Recipients With CPAP-Intolerant Obstructive Sleep Apnea.

OBJECTIVE: In the last decade, hypoglossal nerve stimulation (HNS) has emerged as a therapeutic alternative for patients with obstructive sleep apnea. The original clinical trial cohorts are entering the phase of expected battery depletion (8-12 years). This study aimed to examine the surgical experience with implantable pulse generator (IPG) replacements and the associated long-term therapy outcomes. STUDY DESIGN: Retrospective analysis of patients from the original clinical trial databases (STAR, German post-market) who were followed in the ongoing ADHERE registry. SETTING: International multicenter HNS registry. METHODS: The ADHERE registry and clinical trial databases were cross-referenced to identify the serial numbers of IPGs that were replaced. Data collection included demographics, apnea-hypopnea index (AHI), therapy use, operative times, and adverse events. RESULTS: Fourteen patients underwent IPG replacement 8.3 ± 1.1 years after their initial implantation. Body mass index was unchanged between the original implant and IPG replacement (29 ± 4 vs 28 ± 2 kg/m2 , p = .50). The mean IPG replacement operative time was shorter than the original implant (63 ± 50 vs 154 ± 58 minutes, p < .002); however, 2 patients required stimulation lead replacement which significantly increased operative time. For patients with available AHI and adherence data, the mean change in AHI from baseline to latest follow-up (8.7 ± 1.1 years after de novo implant) was -50.06%, and the mean therapy use was 7.2 hours/night. CONCLUSION: IPG replacement surgery was associated with low complications and shorter operative time. For patients with available outcomes data, adherence and efficacy remained stable after 9 years of follow-up.

Perioperative management of obstructive sleep apnea in lower extremity orthopedic procedures: A review of evidence to inform the development of a clinical pathway.

Obstructive sleep apnea (OSA) is unrecognized in as high as 80% of patients before surgery. When untreated, OSA increases a surgical patient's propensity for airway collapse and sleep deprivation lending to a higher risk for emergent re-intubation, prolonged recovery time, escalation of care, hospital readmission, and longer length of stay. We have reviewed the evidence regarding diagnostic performance of OSA screening methods and the impact of perioperative management strategies on postoperative complications among patients with diagnosed or suspected OSA who are undergoing orthopedic surgery. We then integrated the data and recommendations from professional society guidelines to develop an evidence-based clinical care pathway to optimize the perioperative management of this surgical population. Successful management of patients with diagnosed or suspected OSA encompass five facets of care: screening, education, airway management, medications, and monitoring. This narrative review revealed two gaps in the evidence to inform management of patients undergoing orthopedic surgery 1) during the perioperative setting to include evidence-based interventions that reduce postoperative complications and 2) after discharge to an unmonitored environment. The clinical care pathway as well as perspectives for future research are discussed.

Sleep problems and associations with cardiovascular disease and all-cause mortality in asthma-chronic obstructive pulmonary disease overlap: analysis of the National Health and Nutrition Examination Survey (2007-2012).

STUDY OBJECTIVES: The impact of sleep problems (ie, sleep duration and presence of sleep disorders) on cardiovascular morbidity and all-cause mortality in adults with asthma-chronic obstructive pulmonary disease overlap (ACO) is unknown. METHODS: Using the National Health and Nutrition Examination Survey database (2007-2012 cycles) and National Death Index data, we identified 398 persons with ACO. Data on self-reported physician-diagnosed sleep disorders and cardiovascular disease were collected. Sleep duration in hours was categorized as short (≤ 5 hours), normal (6-8 hours), and long (≥ 9 hours). Associations between sleep duration and presence of sleep disorders and cardiovascular disease and all-cause mortality were analyzed in regression models adjusted for age, sex, race, smoking status, and body mass index. RESULTS: Presence of sleep disorders was more commonly reported in the ACO group (24.7%) compared to all other groups. The ACO group had a higher proportion of short sleepers (27.6%) compared to controls (11.7%) and chronic obstructive pulmonary disease (19.2%) and a higher proportion of long sleepers (6.9%) compared to chronic obstructive pulmonary disease (5.5%). Presence of sleep disorders was associated with increased risk for cardiovascular disease (odds ratio = 2.48; 95% confidence interval, 1.65-3.73) and death (hazard ratio = 1.44; 95% confidence interval, 1.03-2.02); risk did not vary between groups. A stronger association existed between sleep duration and increased risk for cardiovascular and all-cause mortality in ACO compared to chronic obstructive pulmonary disease and controls. CONCLUSIONS: These results suggest that persons with ACO may represent a high-risk group that should be targeted for more aggressive intervention for sleep problems, a modifiable risk factor. CITATION: Baniak LM, Scott PW, Chasens ER, et al. Sleep problems and associations with cardiovascular disease and all-cause mortality in asthma-chronic obstructive pulmonary disease overlap: analysis of the National Health and Nutrition Examination Survey (2007-2012). J Clin Sleep Med. 2022;18(6):1491-1501.

Validation of an overnight wireless high-resolution oximeter plus cloud-based algorithm for the diagnosis of obstructive sleep apnea

OBJECTIVES: Obstructive sleep apnea (OSA) is a common but largely underdiagnosed condition. This study aimed to test the hypothesis that the oxygen desaturation index (ODI) obtained using a wireless high-resolution oximeter with a built-in accelerometer linked to a smartphone with automated cloud analysis, Overnight Digital Monitoring (ODM), is a reliable method for the diagnosis of OSA. METHODS: Consecutive patients referred to the sleep laboratory with suspected OSA underwent in-laboratory polysomnography (PSG) and simultaneous ODM. The PSG apnea-hypopnea index (AHI) was analyzed using the criteria recommended and accepted by the American Academy of Sleep Medicine (AASM) for the definition of hypopnea: arousal or ≥3% O2 desaturation (PSG-AHI3%) and ≥4% O2 desaturation (PSG-AHI4%), respectively. The results of PSG and ODM were compared by drawing parallels between the PSG-AHI3% and PSG-AHI4% with ODM-ODI3% and ODM-ODI4%, respectively. Bland-Altman plots, intraclass correlation, receiver operating characteristics (ROC) and area under the curve (AUC) analyses were conducted for statistical evaluation. ClinicalTrial.gov: NCT03526133. RESULTS: This study included 304 participants (men: 55%; age: 55±14 years; body mass index: 30.9±5.7 kg/m2; PSG-AHI3%: 35.3±30.1/h, ODM-ODI3%: 30.3±25.9/h). The variability in the AASM scoring bias (PSG-AHI3% vs PSG-AHI4%) was significantly higher than that for PSG-AHI3% vs ODM-ODI3% (3%) and PSG-AHI4% vs ODM-ODI4% (4%) (9.7, 5.0, and 2.9/h, respectively; p<0.001). The limits of agreement (2±SD, derived from the Bland-Altman plot) of AASM scoring variability were also within the same range for (PSG vs ODM) 3% and 4% variability: 18.9, 21.6, and 16.5/h, respectively. The intraclass correlation/AUC for AASM scoring variability and PSG vs ODM 3% or 4% variability were also within the same range (0.944/0.977 and 0.953/0.955 or 0.971/0.964, respectively). CONCLUSION: Our results showed that ODM is a simple and accurate method for the diagnosis of OSA.

A Couples-Oriented Intervention for Positive Airway Pressure Therapy Adherence: A Pilot Study of Obstructive Sleep Apnea Patients and Their Partners.

Background: Partner involvement can influence positive airway pressure (PAP) therapy use among patients with obstructive sleep apnea (OSA). This study assessed the feasibility, acceptability, and preliminary efficacy of a couples-oriented education and support (CES) intervention for PAP adherence. Participants: Thirty newly diagnosed OSA patients and their partners were randomly assigned to one of three groups: an education and support intervention directed at both patient and partner (CES), an education and support intervention directed only at the patient (PES), or usual care (UC). Methods: Feasibility and acceptability were assessed through enrollment and posttreatment program evaluations, respectively. Assessments of sleep quality, daytime sleepiness, and daytime function were obtained from both patients and partners at baseline and 3 months after PAP initiation. Objective PAP adherence was assessed at 1 week, 1 month, and 3 months. Results: Recruitment and attrition data suggest adequate feasibility. All patients and partners in the CES group reported that the intervention was helpful. Patients in the CES and PES groups increased their PAP adherence over the first month of treatment, whereas PAP adherence decreased over this period in the UC group. For patients, large to medium effects for sleep quality (d = -1.01), daytime sleepiness (d = -0.51), and daytime function (d = 0.51) were found for the CES group. The PES and UC groups effect sizes were large to small for sleep quality (d = -0.94; d = -0.40), daytime sleepiness (d = -0.42; d = -0.82), and daytime function (d = 0.41; d = 0.57), respectively. For partners, large effects for daytime sleepiness (d = -1.31) and daytime function (d = 1.54) and small to medium effect for sleep quality (d = -0.31) were found for the CES group. Worsening of sleep quality (d = 0.65) and no change in daytime sleepiness or daytime function were found for the PES group. For the UC group, medium to large effects were found for sleep quality (d = -0.77), daytime sleepiness (d = -0.77), and daytime function (d = 0.65). Conclusions: The findings of this pilot study provide support for taking a couples intervention approach to improve PAP adherence.

Hypoglossal Nerve Stimulation and Heart Rate Variability: Analysis of STAR Trial Responders.

OBJECTIVE: Hypoglossal nerve stimulation represents a novel therapy for the treatment of moderate-severe obstructive sleep apnea; nonetheless, its cardiovascular effects are not known. We examine the effects of hypoglossal nerve stimulation on heart rate variability, a measure of autonomic function. STUDY DESIGN: Substudy of the STAR trial (Stimulation Therapy for Apnea Reduction): a multicenter prospective single-group cohort. SETTING: Academic and private practice centers in the United States and Europe. SUBJECTS AND METHODS: A subset of responder participants (n = 46) from the STAR trial was randomized to therapy withdrawal or therapy maintenance 12 months after surgery. Heart rate variability analysis included standard deviation of the R-R interval (SDNN), low-frequency power of the R-R interval, and high-frequency power of the R-R interval. Analysis was performed by sleep with 5-minute sliding window epochs during baseline, 12 months, and the maintenance/withdrawal period. RESULTS: A significant improvement from baseline to 12 months in heart rate variability was seen for SDNN and low frequency across all sleep stages. SDNN analysis demonstrated no change in the wake period (mean ± SD: 0.042 ± 0.01 vs 0.077 ± 0.07, P = .19). Reduction in SDNN was correlated to improvement in apnea-hypopnea index ( r = 0.39, P = .03). In the therapy withdrawal group, no significant changes in SDNN were seen for N1/N2, N3, or rapid eye movement sleep. CONCLUSION: Hypoglossal nerve stimulation therapy appears to reduce heart rate variability during sleep. This reduction was not affected by a 1-week withdrawal period. Larger prospective studies are required to better understand the effect of hypoglossal nerve stimulation on autonomic dysfunction in obstructive sleep apnea.

Upper Airway Stimulation for Obstructive Sleep Apnea: 5-Year Outcomes.

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/m2, 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.

Knowledge Gaps in the Perioperative Management of Adults with Obstructive Sleep Apnea and Obesity Hypoventilation Syndrome. An Official American Thoracic Society Workshop Report.

The purpose of this workshop was to identify knowledge gaps in the perioperative management of obstructive sleep apnea (OSA) and obesity hypoventilation syndrome (OHS). A single-day meeting was held at the American Thoracic Society Conference in May, 2016, with representation from many specialties, including anesthesiology, perioperative medicine, sleep, and respiratory medicine. Further research is urgently needed as we look to improve health outcomes for these patients and reduce health care costs. There is currently insufficient evidence to guide screening and optimization of OSA and OHS in the perioperative setting to achieve these objectives. Patients who are at greatest risk of respiratory or cardiac complications related to OSA and OHS are not well defined, and the effectiveness of monitoring and other interventions remains to be determined. Centers involved in sleep research need to develop collaborative networks to allow multicenter studies to address the knowledge gaps identified below.

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.

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/m(2); 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.

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

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.

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.

Should All Congestive Heart Failure Patients Have a Routine Sleep Apnea Screening? Con.

Sleep-disordered breathing (SDB) is one of the most common comorbidities in people with congestive heart failure (CHF). Although SDB has major cardiometabolic consequences, the attributable risk of SDB in asymptomatic CHF patients remains unclear. Whether early intervention using positive airway pressure would improve the prognosis in CHF patients is uncertain. As yet, there is insufficient evidence that routine polysomnography screening is cost-effective for asymptomatic CHF patients. Careful clinical risk evaluation and thoughtful use of limited-channel home sleep testing should be considered before the application of routine polysomnography in all CHF patients.

Upper Airway Stimulation for Obstructive Sleep Apnea: Past, Present, and Future.

ABSTRACT: Obstructive sleep apnea (OSA) is an increasingly prevalent clinical problem with significant effects on both personal and public health. Continuous positive airway pressure (CPAP) has demonstrated excellent efficacy and low morbidity; long-term adherence rates approach 50%. Although traditional upper airway surgical procedures target the anatomic component of obstruction, upper airway stimulation tackles the twin goals of improving anatomic and neuromuscular pathology. After decades of trials demonstrating proof of concept of hypoglossal nerve stimulation in animal and human subjects, the results of a large multicenter, prospective trial were recently published. The trial demonstrated that hypoglossal nerve stimulation led to significant improvements in objective and subjective measurements of the severity of OSA. This novel approach is the first to combine sleep surgery techniques with a titratable medical device for the treatment of OSA. Further research is required to define optimal patient selection and device performance and to demonstrate long-term effectiveness.

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.

Traditional and nontraditional cardiovascular risk factors in comorbid insomnia and sleep apnea.

OBJECTIVES: Insomnia and sleep apnea frequently co-occur and are independently associated with an increased risk of cardiovascular disease, but little is known about cardiovascular disease risk among individuals with comorbid insomnia and sleep apnea. The current study examined traditional risk factors and a physiologic biomarker of cardiovascular risk in comorbid insomnia and sleep apnea. DESIGN: Community-based participatory research study. PARTICIPANTS: The sample comprised 795 participants without preexisting cardiovascular disease from the Heart Strategies Concentrating On Risk Evaluation (Heart SCORE) study. MEASUREMENTS AND RESULTS: Participants were assessed for symptoms of insomnia and sleep apnea risk, as well as for presence of obesity, smoking, a sedentary lifestyle, hypertension, dyslipidemia, and diabetes. Baseline resting brachial artery diameter was measured by B-mode ultrasonography. A total of 138 participants (17.4%) met criteria for insomnia syndrome alone, 179 (22.5%) were at high risk for sleep apnea alone, 95 (11.9%) reported both insomnia syndrome and high sleep apnea risk, and 383 (48.2%) reported having neither insomnia nor sleep apnea symptoms Both high sleep apnea risk alone and comorbid insomnia and high sleep apnea risk groups had greater frequencies of obesity, sedentary lifestyle, hypertension, and three or more traditional cardiovascular risk factors and significantly larger brachial artery diameters than the insomnia alone group and those without insomnia or sleep apnea symptoms. No differences in traditional cardiovascular risk factors or brachial artery diameter were found between the high sleep apnea risk and comorbid groups. CONCLUSIONS: These findings suggest that sleep apnea is a major contributor to cardiovascular risk and co-occurring insomnia does not appear to add to this risk.

Sleep: a health imperative.

Chronic sleep deficiency, defined as a state of inadequate or mistimed sleep, is a growing and underappreciated determinant of health status. Sleep deprivation contributes to a number of molecular, immune, and neural changes that play a role in disease development, independent of primary sleep disorders. These changes in biological processes in response to chronic sleep deficiency may serve as etiological factors for the development and exacerbation of cardiovascular and metabolic diseases and, ultimately, a shortened lifespan. Sleep deprivation also results in significant impairments in cognitive and motor performance which increase the risk of motor vehicle crashes and work-related injuries and fatal accidents. The American Academy of Sleep Medicine and the Sleep Research Society have developed this statement to communicate to national health stakeholders the current knowledge which ties sufficient sleep and circadian alignment in adults to health.

Clinical guideline for the evaluation, management and long-term care of obstructive sleep apnea in adults.

BACKGROUND: Obstructive sleep apnea (OSA) is a common chronic disorder that often requires lifelong care. Available practice parameters provide evidence-based recommendations for addressing aspects of care. OBJECTIVE: This guideline is designed to assist primary care providers as well as sleep medicine specialists, surgeons, and dentists who care for patients with OSA by providing a comprehensive strategy for the evaluation, management and long-term care of adult patients with OSA. METHODS: The Adult OSA Task Force of the American Academy of Sleep Medicine (AASM) was assembled to produce a clinical guideline from a review of existing practice parameters and available literature. All existing evidence-based AASM practice parameters relevant to the evaluation and management of OSA in adults were incorporated into this guideline. For areas not covered by the practice parameters, the task force performed a literature review and made consensus recommendations using a modified nominal group technique. RECOMMENDATIONS: Questions regarding OSA should be incorporated into routine health evaluations. Suspicion of OSA should trigger a comprehensive sleep evaluation. The diagnostic strategy includes a sleep-oriented history and physical examination, objective testing, and education of the patient. The presence or absence and severity of OSA must be determined before initiating treatment in order to identify those patients at risk of developing the complications of sleep apnea, guide selection of appropriate treatment, and to provide a baseline to establish the effectiveness of subsequent treatment. Once the diagnosis is established, the patient should be included in deciding an appropriate treatment strategy that may include positive airway pressure devices, oral appliances, behavioral treatments, surgery, and/or adjunctive treatments. OSA should be approached as a chronic disease requiring long-term, multidisciplinary management. For each treatment option, appropriate outcome measures and long-term follow-up are described.