Hypoxic burden (HB) is a novel metric used to characterize the physiological impact of obstructive sleep apnea (OSA). Prior studies have shown HB to strongly correlate with cardiovascular (CV) risk. While the hypoglossal nerve stimulator (HGNS) has been shown to effectively reduce AHI, its impact on HB remains underexplored. This study examines the effect of HGNS on subjective and objective outcomes in OSA, including HB. We conducted a retrospective review of 72 patients who underwent HGNS and completed home sleep apnea testing (HSAT) before and after surgery at our institution. Data collected included demographics, pre- and postoperative AHI, body mass index (BMI), oxygen desaturation index (ODI), and Epworth sleepiness score (ESS). HB was calculated using the SpO2 signal from sleep studies at baseline and post-optimization of HGNS therapy (The Siesta Group, Vienna Austria). Treatment success was evaluated using the Sher20 criteria, and the paired Wilcoxon test and Wilcoxon Rank Sum Test were used to assess outcomes. The mean age and BMI of the patients were 64.5 years and 28.7 kg/m², with 76.1% being male. The Sher20 success rate was 52.8%. Statistically significant reductions were seen in AHI (33.1 to 17.8, p < 0.001), ESS (11.4 to 7.7, p < 0.001), HB (102.5 to 62.9, p < 0.001), and ODI (29.5 to 14.8, p < 0.001) after HGNS. Significant differences were observed in ODI and HB changes between Sher20 responders and non-responders, while ESS changes were not significantly different. HGNS resulted in significant improvements in both objective and subjective outcomes of OSA, including HB. These findings suggest that HGNS may be useful in alleviating physiological impacts associated with OSA.
AD109 is a combination of a novel antimuscarinic, aroxybutynin (aroxy; R-enantiomer of oxybutynin), and the selective norepinephrine reuptake inhibitor atomoxetine (ato). We report the sample characteristics of the fully enrolled SynAIRgy trial, a Phase 3 study to examine the efficacy, safety, and tolerability of AD109 (aroxy 2.5mg/ato 75 mg) in OSA. SynAIRgy (NCT05813275) is a randomized, double blind, placebo-controlled, 6-month parallel-arm clinical trial in adults with OSA who do not accept or adhere to positive airway pressure therapy. Participants were enrolled over the full range of OSA severity as measured by apnea-hypopnea index with 4% desaturation (AHI4) >5 with no upper limit. Participants must have had a Patient Reported Outcomes Measurement Information System (PROMIS) -Fatigue raw score ≥17, and a body mass index (BMI) between 18.5–40 kg/m2 for men, or 18.5–42 kg/m2 for women. The primary efficacy endpoint is the proportion of participants with ≥50% reduction in AHI4 at six months. Secondary efficacy endpoints include change from baseline in PROMIS-Fatigue, PROMIS-Sleep Impairment (a measure of functional impairment during daytime), and Epworth Sleepiness Scale (ESS). SynAIRgy enrolled 646 participants that were randomized to AD109 or placebo. At baseline, the mean (SD) age was 57.1 (11.0) years, and mean (SD) BMI was 32.3 (5.0) kg/m2 with a balanced proportion of female (n=317, 49.1%) and male (329, 50.9 %) participants. The study enrolled a population representative of the diverse demographic composition of the United States with 67.2% being White, 20.4% Black/African American, 7.4% Asian, 1.1% American Indian/Alaskan Native, and 0.6% Native Hawaiian/Other Pacific Islander. The mean (SD) AHI4 at baseline was 22 (11) with 34.4%, 42.4%, and 23.2% of participants having mild (AHI4 5–< 15) moderate (AHI4 15–< 30), or severe (AHI4 ≥30) OSA, respectively. Mean (SD) PROMIS-Fatigue T-score was 59.1 (7.0), mean (SD) PROMIS-Sleep Impairment T-score score was 58.5 (7.5), and mean (SD) ESS was 10.1 (4.7). The baseline demographic characteristics of participants enrolled in SynAIRgy are representative of the general population of adults living with OSA, and the baseline AHI4 scores and symptom profiles reflect those of a typical sleep clinic referral OSA population. Apnimed Inc.
STUDY OBJECTIVES:The impact of rapid eye movement (REM) sleep duration on long-term adherence to continuous positive airway pressure (CPAP) therapy in patients with obstructive sleep apnea (OSA) is unclear. This study aimed to assess the characteristics of individuals with short REM sleep and investigate whether reduced REM sleep is associated with lower CPAP adherence over a two-year period in the RICCADSA cohort. METHODS:This secondary analysis included participants from the RICCADSA trial who had total sleep time of at least 240 min on baseline polysomnography and available CPAP adherence data for two years. Participants were categorized into short REM sleep (<30 min) and normal REM sleep (≥30 min) groups. Sleep parameters, clinical characteristics, and CPAP adherence data were analyzed. RESULTS:Among 253 participants, 52 (20.6 %) had short REM sleep. The short REM sleep group was older (66.8 vs. 63.0 years, p = 0.002), had a higher prevalence of obesity (48.1 % vs. 31.3 %, p = 0.024), underwent more frequent coronary artery bypass grafting (38.5 % vs. 22.4 %, p = 0.018), and had higher rates of anxiety (33.3 % vs. 16.4 %, p = 0.007). They exhibited shorter total sleep time, longer sleep onset latency, reduced sleep efficiency, and more severe OSA (AHI: 56.7 vs. 31.4 events/h, p < 0.001). Regression analysis revealed that short REM sleep was significantly associated with lower CPAP adherence at two years (β = -0.15, 95 % CI: 1.92 to -0.09, p = 0.031). CONCLUSIONS:Short REM sleep is associated with older age, obesity, higher anxiety levels, and more severe OSA. Importantly, it is linked to lower long-term CPAP adherence, underscoring the need to identify and support this subgroup to improve treatment outcomes. CLINICAL REGISTRATION:The study was registered at the national research website in Sweden through the database of the Skaraborg Hospital (nr VGSKAS-4731; 04.29.2005) as well as with ClinicalTrials.gov, number NCT00519597.
Obstructive sleep apnea is associated with cognitive impairment; however, the underlying mechanisms remain incompletely understood. Obstructive sleep apnea is characterized by periods of interrupted ventilation (ventilatory burden), leading to hypoxemia (hypoxic burden) and/or arousal (arousal burden) from sleep. Although hypoxemia is considered a key mechanism underlying white matter injury, its measurement has been limited. In our primary analysis, we assessed the association of hypoxic burden, a quantitative measure of hypoxemia, with white matter hyperintensity volume, a marker of small vessel disease, and compared it with that of ventilatory burden and arousal burden (quantitative measures of ventilatory deficit and arousals). Data from participants in the Multi-Ethnic Study of Atherosclerosis with full polysomnograms and brain magnetic resonance imaging were analyzed. Hypoxic burden was defined as the total area under the oxygen desaturation curve per hour of sleep, ventilatory burden was defined as the event-specific area under the ventilation signal, and arousal burden was defined as the normalized cumulative duration of all arousals. The primary outcome was white matter hyperintensity volume, with other magnetic resonance imaging measures considered secondary outcomes. The analysis included polysomnograms from 587 participants (age: 65.5 ± 8.2 years). In the fully adjusted model, each 1 standard deviation increase in hypoxic burden was associated with a 0.09 standard deviation increase in white matter hyperintensity volume (P = .023), after adjusting for demographics, study site, and comorbidities. In contrast, ventilatory burden, arousal burden, and conventional obstructive sleep apnea measures were not associated with outcomes. Hypoxic burden was associated with white matter hyperintensity volume in a racially/ethnically diverse cohort of older individuals with a high prevalence of obstructive sleep apnea . Hajipour M, Hu W-H, Esmaeili N, et al. Sleep apnea physiological burdens and markers of white matter injury: the Multi-Ethnic Study of Atherosclerosis. J Clin Sleep Med. 2025;21(3):457–466.
Mean disease alleviation measures the effectiveness of Obstructive Sleep Apnea (OSA) treatments. It combines a patient's adherence to treatment normalized to their total sleep time and the treatment's efficacy as determined by the change in the apnea-hypopnea index. This metric fails to capture the patient's OSA-related symptoms, which are a key component and, in some cases, the primary component, of determining response to treatment.We propose an enhanced metric called three-dimensional mean disease alleviation (3D-MDA), which incorporates the symptom response to better reflect the true treatment impact. Results The proposed 3D-MDA metric aims to provide a more comprehensive assessment of OSA treatment effectiveness by integrating the subjective impact, therapy adherence, and objective efficacy. Further, 3D-MDA is adaptable over time as the optimal metrics for these categories continue to evolve.
There is a critical need to create sustainable interventions for the nearly 80% of patients with undiagnosed obstructive sleep apnea (OSA), particularly in rural communities where notable health disparities exist. The West Virginia OSA Academic Mentoring Partnership (WV OSA AMP) was developed to address this care gap and sustainably engage rural primary care providers in the management of OSA. This study analyzed acceptability and feasibility outcomes from the initial cohort of providers enrolled in WV OSA AMP. WV OSA AMP was developed from implementation science/community engagement methodologies utilizing the VA Quality Enhancement Initiative to develop a roadmap for implementation of the training and support intervention. This study assessed initial feasibility and acceptability outcomes of the WV OSA AMP based on post-training questionnaires. The Feasibility of Implementation Measure (FIM) and the Acceptability of Implementation Measure (AIM) are validated measures that use a 5-point Likert scale to assess agreement across participant perspectives on the feasibility and acceptability of the program. Of the 14 participants, seven have completed the post training surveys. Analysis of the AIM revealed an average score of 4.7 out of 5 across all domains. No respondents disagreed or completely disagreed with items relating to the acceptability of the intervention. Analysis of the FIM revealed an average score of 4.7 in the domains of: 1) the intervention seems implementable, 2) the intervention seems possible, and 3) the intervention seems doable. An average score of 4.6 was recorded in the domain ‘this intervention seems easy to use’. Our results demonstrate high levels of acceptability and feasibility in the initial cohort of WV OSA AMP participants. These findings support the notion that community engagement and implementation science can lead to effective programs that address care disparity for sleep disorders in disadvantaged areas. The next WV OSA AMP sessions are scheduled for January 30 and April 30, 2025. We plan to repeat these assessments and be able to analyze outcomes in a larger sample. We will also perform a qualitative analysis of semi-structured interviews with participants. Supported by NIH K23 HL161437-0A1. AASM Foundation (SR2332) funded, declined by PI due to overlap.
Rationale: There is a critical need to create sustainable interventions for the nearly 80% of patients with undiagnosed obstructive sleep apnea (OSA), particularly in rural communities where notable health disparities exist. Objectives: The objective of this study is to use implementation science and community-engaged research methods to address OSA care disparity in West Virginia by designing an intervention to support primary care providers (PCPs) who treat patients in rural West Virginia. Our overall project is grounded in context-sensitive approaches to address the unique challenges of OSA management in the rural primary care setting. Here we describe the preimplementation work conducted to identify the determinants of implementation in rural settings and the selection of strategies that led to the initial program and will inform our prospective implementation effectiveness study. Methods: The Veterans Affairs Quality Enhancement Research Initiative implementation roadmap considers all levels of a healthcare system and provides a pragmatic approach to program implementation, which is carried out through three phases: preimplementation, implementation, and sustainment. Barriers and facilitators were mapped to the domains of the Consolidated Framework for Implementation Research (CFIR) to inform our implementation plan. We derived Expert Recommendations for Implementing Change strategies from the CFIR mapping exercise to identify the strategies that would improve implementation outcomes in rural primary care. Results: Themes identified from our previous mixed-methods community engagement study with PCPs were reviewed and mapped to CFIR domains and coded as implementation barriers or facilitators. Facilitators included provider recognition of the relative importance of OSA management, provider knowledge about OSA, and perceived patient receptivity to having a PCP evaluate and treat OSA. Predominant barriers included PCPs' relatively low self-reported confidence in their ability to identify or manage OSA, challenges with clinical process and workflow that facilitate program adoption, and a relative lack of community-based resources or networks to support patients in such a program. One major barrier mapped to the CFIR domain "inner setting" was lack of clinical processes to support OSA screening, testing, and referrals. The implementation strategy category that was identified to be most important for the OSA care program implementation was "Develop stakeholder interrelationships." Other important strategy categories included "Provide interactive assistance" and "Support for clinicians" in the targeted rural communities. Conclusions: Leveraging a community-engaged approach and using implementation science informed the development and implementation of a novel OSA program to educate and support PCPs in OSA diagnosis and management that is tailored to the realities of rural primary care. This program, the West Virginia Obstructive Sleep Apnea Academic Mentoring Partnership, is well positioned to address the care disparity for OSA in rural communities in a sustainable way.
With the rising prevalence of severe obesity, the coexistence of obstructive sleep apnea (OSA) and chronic obstructive pulmonary disease (COPD) often progresses to triple overlap syndrome, a condition with significant health implications. However, its prevalence remains poorly understood. Using population-based data from the National Health and Nutrition Examination Survey (NHANES), we examined the prevalence of triple overlap of COPD, severe obesity, and high risk for OSA (HR-OSA) and associated sociodemographic factors among US adults. A cross-sectional analysis was performed using NHANES data between 2005 and 2008 and 2015-March 2020. COPD diagnosis was collected via self-report questionnaire. HR-OSA was determined by an adapted Multivariable Apnea Prediction index. Severe obesity was defined as a body mass index of ≥ 40.0 kg/m2. From 2005 to 2008 to 2015-March 2020, the proportion of participants with triple overlap of COPD, severe obesity, and HR-OSA increased from 0.653
Hypoglossal nerve stimulation (HGNS) is an implantable device for treating Obstructive Sleep Apnea (OSA) by electrically stimulating the hypoglossal nerve to move the tongue and relieve airway obstruction. The STAR trial showed a significant reduction in the apnea-hypopnea index (AHI) at 12 months. This study evaluates: 1) HGNS’s effect on hypoxic burden (HB) at 12 months, 2) the percentage of individuals transitioning from high HB (≥60 %min/h, linked to increased cardiovascular risk) to low HB (i.e. < 60 %min/h), and 3) the impact of active HGNS versus withdrawal after 12 months in a subset of participants. A secondary analysis of the STAR Trial (NCT01161420) measured HB from SpO2 signals during sleep studies at baseline, 12 months (including 1-week withdrawal), and 18 months of HGNS therapy. The median HB was 63 [48–95] %min/h (N=108; 84% male; mean (SD) age 55 (10) years; AHI 30 [25–40] events/h). After 12 months, the median HB reduction was 77% [36%–90%]. Among those with high baseline HB (≥60 %min/h; N=62; age 56 (10) years), 79% achieved low HB (79% [50%-90%] reduction from baseline).In individuals with a low HB at baseline (< 60 %min/h; N=46; age= 53 (11) years), the median HB changed from 45 [36 - 53] to 11 [3.1 - 34] %min/h. Finally, therapy-maintenance subgroup (N=19) had an HB of 69 [52 - 92], 12 [5.2 - 20], 15 [3.3 - 26], and 15 [4.8 - 26] %min/h at baseline, 12-month, 12-month+1-week, and 18-month, respectively. Therapy-withdrawal subgroup (N=18) had an HB of 55 [38 - 78], 11 [7.0 - 15], 35 [22 - 66], and 15 [13 - 27] %min/h at baseline, 12-month, 12-month+1 week, and 18-month, respectively. The 1-week change in HB from 12-month was 43 [95% CI: 6.6 - 77] %min/h higher in the therapy withdrawal versus therapy maintenance subgroup (p=0.027) but failed to reach baseline values. HGNS reduces HB after 12 months in OSA patients, with 79% of those at high baseline HB achieving low HB. Therapy effects persisted at 18 months, while a 1-week withdrawal did not fully restore HB to baseline. AASMF 287-SR-22, NIH NHLBI R01HL153874, Inspire
Obstructive sleep apnea is a prevalent disorder associated with significant health risks, often managed with continuous positive airway pressure. However, continuous positive airway pressure adherence remains suboptimal, prompting interest in surgical alternatives. Traditional uvulopalatopharyngoplasty (UPPP), introduced in 1981, has demonstrated limited success and notable side effects, leading to skepticism regarding its utility in obstructive sleep apnea treatment. However, advancements in patient selection and surgical technique have led to the development of modified UPPP procedures, including expansion sphincter pharyngoplasty, barbed reposition pharyngoplasty, and the Australian modified UPPP. In this narrative review, we focus on the evolution of the palatal surgery field over the past 2 decades. Recent randomized controlled trials and observational cohort studies have shown that modified UPPP variants can significantly reduce apnea-hypopnea index, improve symptoms, and even offer potential cardiovascular benefits. These reconstructive approaches have demonstrated consistently improved success rates, enhanced patient-reported outcomes, and reduced postoperative morbidity compared to traditional excisional UPPP. While controversies persist regarding patient selection, long-term durability, and the role of palate surgery in the era of hypoglossal nerve stimulation, emerging evidence supports modified UPPP as a viable alternative for appropriately selected patients with obstructive sleep apnea. This review underscores the evolution of palatal surgery, highlighting its role in a personalized, multimodal approach to obstructive sleep apnea management, particularly for continuous positive airway pressure-intolerant patients seeking durable and effective treatment. Kaffenberger TM, Soose RJ, Woodson BT, et al. Modified uvulopalatopharyngoplasty in modern obstructive sleep apnea treatment: a narrative review. J Clin Sleep Med. 2025;21(11):1979–1991.
HomeCirculation: Genomic and Precision MedicineVol. 17, No. 2CYB5R3 T117S Genetic Mutation Is Associated With Major Adverse Cardiovascular and Cerebrovascular Events in Black Adults No AccessLetterRequest AccessFull TextAboutView Full TextView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissions ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toNo AccessLetterRequest AccessFull TextCYB5R3 T117S Genetic Mutation Is Associated With Major Adverse Cardiovascular and Cerebrovascular Events in Black Adults Rahul Chaudhary, Adam C. Straub, Felix E.Y. Aggor, Ifeoluwa Onasanya, Jordan Richardson, Patrick J. Strollo, Steven E. Reis and Oladipupo Olafiranye Rahul ChaudharyRahul Chaudhary https://orcid.org/0000-0002-3276-385X Division of Cardiology, Department of Medicine, Heart and Vascular Institute, University of Pittsburgh School of Medicine (R.C., F.E.Y.A., S.E.R.). , Adam C. StraubAdam C. Straub https://orcid.org/0000-0003-0542-9466 Department of Pharmacology and Chemical Biology (A.C.S.). Heart, Lung, Blood and Vascular Medicine Institute, University of Pittsburgh, PA (A.C.S., P.J.S.). , Felix E.Y. AggorFelix E.Y. Aggor https://orcid.org/0000-0002-0327-0095 Division of Cardiology, Department of Medicine, Heart and Vascular Institute, University of Pittsburgh School of Medicine (R.C., F.E.Y.A., S.E.R.). , Ifeoluwa OnasanyaIfeoluwa Onasanya https://orcid.org/0000-0003-1126-0425 College of Arts and Sciences, Howard University, Washington, DC (I.O., J.R.). , Jordan RichardsonJordan Richardson College of Arts and Sciences, Howard University, Washington, DC (I.O., J.R.). , Patrick J. StrolloPatrick J. Strollo https://orcid.org/0000-0002-2065-9641 Heart, Lung, Blood and Vascular Medicine Institute, University of Pittsburgh, PA (A.C.S., P.J.S.). Department of Medicine, VA Pittsburgh Healthcare System, PA (P.J.S.). , Steven E. ReisSteven E. Reis https://orcid.org/0000-0001-8023-0102 Division of Cardiology, Department of Medicine, Heart and Vascular Institute, University of Pittsburgh School of Medicine (R.C., F.E.Y.A., S.E.R.). and Oladipupo OlafiranyeOladipupo Olafiranye Correspondence to: Oladipupo Olafiranye, MD, MS Associate Professor of Medicine Division of Cardiology, Department of Medicine University of Texas Southwestern Medical Center VA N Texas Healthcare System 4500 S Lancaster Rd Dallas, TX 75216 Tel: 214-857-2923 E-mail: E-mail Address: [email protected] https://orcid.org/0000-0003-4534-7588 Division of Cardiology, Department of Medicine, University of Texas Southwestern Medical Center and VA North Texas Healthcare System, Dallas (O.O.). Originally published14 Feb 2024https://doi.org/10.1161/CIRCGEN.123.004271Circulation: Genomic and Precision Medicine. 2024;17FootnotesFor Sources of Funding and Disclosures, see page 163.Correspondence to: Oladipupo Olafiranye, MD, MS Associate Professor of Medicine Division of Cardiology, Department of Medicine University of Texas Southwestern Medical Center VA N Texas Healthcare System 4500 S Lancaster Rd Dallas, TX 75216 Tel: 214-857-2923 E-mail: oladipupo.olafiranye@utsouthwestern.eduREFERENCES1. Franceschini N, Fox E, Zhang Z, Edwards TL, Nalls MA, Sung YJ, Tayo BO, Sun YV, Gottesman O, Adeyemo A, et al; Asian Genetic Epidemiology Network Consortium. Genome-wide association analysis of blood-pressure traits in African-ancestry individuals reveals common associated genes in African and non-African populations.Am J Hum Genet. 2013; 93:545–554. doi: 10.1016/j.ajhg.2013.07.010CrossrefMedlineGoogle Scholar2. Carew NT, Schmidt HM, Yuan S, Galley JC, Hall R, Altmann HM, Hahn SA, Miller MP, Wood KC, Gabris B, et al. Loss of cardiomyocyte CYB5R3 impairs redox equilibrium and causes sudden cardiac death.J Clin Invest. 2022; 132:e147120. doi: 10.1172/JCI147120CrossrefMedlineGoogle Scholar3. Olafiranye O, Kip KE, Rhinehart Z, Mulukutla SR, Aiyer A, Strollo PJ, Reis SE. Impact of race and obesity on arterial endothelial dysfunction associated with sleep apnea: results from the Heart SCORE study.Int J Cardiol. 2015; 201:476–478. doi: 10.1016/j.ijcard.2015.08.098CrossrefMedlineGoogle Scholar4. Durgin BG, Wood KC, Hahn SA, McMahon B, Baust JJ, Straub AC. Smooth muscle cell CYB5R3 preserves cardiac and vascular function under chronic hypoxic stress.J Mol Cell Cardiol. 2022; 162:72–80. doi: 10.1016/j.yjmcc.2021.09.005CrossrefMedlineGoogle Scholar5. Chaudhary R, Bliden KP, Kreutz RP, Jeong YH, Tantry US, Levy JH, Gurbel PA. Race-Related disparities in COVID-19 thrombotic outcomes: beyond social and economic explanations.EClinicalMedicine. 2020; 29:100647. doi: 10.1016/j.eclinm.2020.100647CrossrefMedlineGoogle Scholar eLetters(0)eLetters should relate to an article recently published in the journal and are not a forum for providing unpublished data. Comments are reviewed for appropriate use of tone and language. Comments are not peer-reviewed. Acceptable comments are posted to the journal website only. Comments are not published in an issue and are not indexed in PubMed. Comments should be no longer than 500 words and will only be posted online. References are limited to 10. 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Abstract Introduction Sleep medicine training in pulmonary and critical care (PCCM) fellowships varies widely. The lack of formal curriculum and local pilot data demonstrating limited mastery of sleep medicine concepts via typical clinical exposure prompted us to develop, implement, and evaluate a sleep disordered breathing curriculum for first year PCCM fellows. Methods This educational study utilizes a historical control pre-test post-test model. The intervention arm consists of first-year PCCM fellows (n = 7) who completed a 10-question evaluation prior to fellowship-level education. They participated in a novel curriculum and are completing the same test upon conclusion of the curriculum. The curriculum is based on five case vignettes covering obstructive sleep apnea, obesity hypoventilation and sleep disordered breathing in COPD, heart failure, and neuromuscular disease. The control arm is comprised of PCCM fellows (n = 6) who have not had exposure to the SDB curriculum. They completed the evaluation at the conclusion of first year and at the beginning of their third year of fellowship. The evaluation was developed by local and national pulmonary and sleep medicine educators with expertise in question-writing. Results Test scores amongst the control group remained low at the end of first year of fellowship, with a mean score of 6/10 (60% +/- 8.9) and have remained low at the beginning of their third year of fellowship with a mean score of 5/10 (50% +/- 11.5%). When asked using a 5 point Likert scale (1=totally uncomfortable, 5=totally comfortable), to assess their comfort with the diagnosis and management of obstructive sleep apnea, the overall average response of 3.08 +/- 0.63 suggests limited comfort with these concepts. In regards to the intervention group, the mean pre-test score prior to beginning the curriculum was 3.71/10, (37.1% +/- 26.3%). Post-curriculum testing and data collection is ongoing with the intervention group, but preliminarily suggests an improvement in comfort level. Conclusion We suspect that the intervention group will demonstrate improved knowledge and comfort in the management of SDB. These results would suggest that our curriculum offers an opportunity to increase the number of pulmonologists who are able to care for the growing population of patients with SDB. Support (if any)
ObjectiveSince 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.MethodsBetween 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.ResultsThere 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.ConclusionOur survey demonstrates a wide variability in sleep‐focused fellowships for surgeons, but the employment market for these trainees is robust.Level of EvidenceN/A Laryngoscope, 2024
Abstract Introduction There are no FDA-approved drugs available for the treatment of obstructive sleep apnea (OSA). The relaxation of upper airway muscles at sleep onset and insufficient muscle reactivation during obstructive events are the key pathophysiological determinants of OSA. Pharmacotherapy targeting the activation of upper airway muscles is a promising strategy for the alleviation of OSA. Methods AD109 is a combination of the antimuscarinic aroxybutynin 2.5 mg, the R-enantiomer of oxybutynin, and the norepinephrine reuptake inhibitor atomoxetine 75 mg. In the phase 2b Mariposa trial, AD109 demonstrated a clinically significant reduction of -47.1% (95% CI: -61.2 to -27.9) in the apnea-hypopnea index (AHI) compared to a placebo, along with an important decrease in subjective fatigue, measured using the Patient Reported Outcome Measurement Information System (PROMIS) scale, at one month of treatment. The ongoing SYNAIRGY study, a placebo-controlled 26-week phase 3 clinical trial, is designed to investigate both the efficacy and safety of AD109 2.5/75 for the treatment of mild to severe OSA. Eligible participants include adults with AHI4 (4% desaturation definition for hypopneas) ≥5, and a BMI < 42kg/m2 for women and < 40 kg/m2 for men who either decline or are unable to tolerate continuous positive airway pressure treatment. Approximately 640 participants will be randomized in a 1:1 ratio to receive either placebo or AD109. We hypothesize that AD109 treatment will provide a clinically meaningful AHI decrease compared to placebo-treated participants with OSA. Results The primary endpoint is the response rate in the AD109 arm vs. placebo arm, where response is defined as >50% reduction in AHI4 from baseline to 26-week polysomnogram (PSG). Participants will have a PSG on treatment at week 4. Secondary endpoints include changes from baseline in PROMIS-Fatigue, PROMIS-Sleep Impairment, hypoxic burden, Patient Global Impression of Severity (PGI-S) for fatigue, and the Epworth Sleepiness Scale. Safety assessments will include multiple in-office measurements of heart rate and blood pressure throughout the treatment period. Conclusion The SynAIRgy phase 3 randomized, controlled clinical trial aims to assess the efficacy and safety of AD109 in in the treatment of OSA by targeting key pathophysiologic mechanisms of upper airway muscle relaxation during sleep. Support (if any) Apnimed
This perspective on alternatives to positive airway pressure (PAP) therapy for the treatment of obstructive sleep apnea (OSA) summarizes the proceedings of a focus group that was conducted by the Sleep Research Society Foundation. This perspective is from a multidisciplinary panel of experts from sleep medicine, dental sleep medicine, and otolaryngology that aims to identify the current role of oral appliance therapy and hypoglossal nerve stimulation for the treatment of OSA with emphasis on the US practice arena. A secondary aim is to identify-from an implementation science standpoint-the various barriers and facilitators for adoption of non-PAP treatment that includes access to care, multidisciplinary expertise, reimbursement, regulatory aspects, current treatment guidelines, health policies, and other factors related to the delivery of care. The panel has contextualized the review with recent events-such as a large-scale PAP device recall compounded by supply chain woes of the pandemic-and emerging science in the field of OSA and offers solutions for multidisciplinary approaches while identifying knowledge gaps and future research opportunities.
We present a concise review of the background, pitfalls, and potential solutions for the noninvasive evaluation and continuous tracking of cardiac autonomic nervous system activity (ANSA), using surface-ECG-accessible parameters, including heart rate (HR), heart-rate variability (HRV), and cardiac repolarization. These parameters have provided insights into the dynamics of cardiac ANSA in controlled experiments and have proved useful in risk assessment with respect to sudden cardiac death and all-cause mortality in some patient populations, as well as in implantable device programming. Yet attempts to translate these parameters from the laboratory environment to ambulatory settings have been hampered by the presence of multiple uncontrolled factors, including changes in blood pressure, body position, physical activity, and respiration frequency. We show that a single-parameter-based, simplified cardiac ANSA evaluation in an uncontrolled ambulatory setting could be inaccurate, and we discuss several approaches to improve accuracy. Discerning cardiac ANSA effects in uncontrolled ambulatory environments requires tracking multiple physiological processes, preferably using multisensor, multiparametric monitoring and controlling some physiological variables (e.g., respiration frequency); data fusion and machine-learning-based analytics are instrumental for developing more accurate personalized ANSA evaluation.