Long-term health outcomes for patients with obstructive sleep apnea: placing the Agency for Healthcare Research and Quality report in context-a multisociety commentary.

This multisociety commentary critically examines the Agency for Healthcare Research and Quality (AHRQ) final report and systematic review on long-term health outcomes in obstructive sleep apnea. The AHRQ report was commissioned by the Centers for Medicare & Medicaid Services and particularly focused on the long-term patient-centered outcomes of continuous positive airway pressure, the variability of sleep-disordered breathing metrics, and the validity of these metrics as surrogate outcomes. This commentary raises concerns regarding the AHRQ report conclusions and their potential implications for policy decisions. A major concern expressed in this commentary is that the AHRQ report inadequately acknowledges the benefits of continuous positive airway pressure for several established, long-term clinically important outcomes including excessive sleepiness, motor vehicle accidents, and blood pressure. While acknowledging the limited evidence for the long-term benefits of continuous positive airway pressure treatment, especially cardiovascular outcomes, as summarized by the AHRQ report, this commentary reviews the limitations of recent randomized controlled trials and nonrandomized controlled studies and the challenges of conducting future randomized controlled trials. A research agenda to address these challenges is proposed including study designs that may include both high quality randomized controlled trials and nonrandomized controlled studies. This commentary concludes by highlighting implications for the safety and quality of life for the millions of people living with obstructive sleep apnea if the AHRQ report alone was used by payers to limit coverage for the treatment of obstructive sleep apnea while not considering the totality of available evidence. CITATION: Patil SP, Billings ME, Bourjeily G, et al. Long-term health outcomes for patients with obstructive sleep apnea: placing the Agency for Healthcare Research and Quality report in context-a multisociety commentary. J Clin Sleep Med. 2024;20(1):135-149.

Optimal NIV Medicare Access Promotion: Patients With OSA: A Technical Expert Panel Report From the American College of Chest Physicians, the American Association for Respiratory Care, the American Academy of Sleep Medicine, and the American Thoracic Society.

This document summarizes the work of the CPAP and bilevel PAP therapy for OSA Technical Expert Panel working group. For positive airway pressure (PAP) therapy, the most pressing current coverage barriers identified were: an insufficient symptom list describing all potential symptoms in patients with mild OSA; the 4 h per night of PAP usage requirement to keep the device; the additional sleep studies requirement to re-qualify for PAP or supplemental oxygen; and the inability to use telehealth visits for follow-up visits. Critical evidence supports changes to current policies and includes: symptom list inadequate to cover all scenarios based on updated clinical practice guidelines; published evidence that 2 h per night of PAP use can result in benefit to quality of life and other metrics; the costs of another sleep study not justified for all nonadherent patients or for supplemental oxygen due to other types of assessment currently available; and the remarkable success and acceptance of telehealth visits. To achieve optimal access for patients on PAP therapy, we make the following key suggestions: removing symptom criteria for mild OSA; reduce continued coverage criteria to > 2 h per night; eliminate the need for a sleep study to re-qualify if nonadherent or for new Centers for Medicare & Medicaid Services beneficiaries already on and adherent to PAP therapy; allow telehealth visits for documenting benefit and adherence; and allow PAP reports and domiciliary oximetry to qualify for supplemental oxygen with PAP if needed. This paper shares our best vision for bringing the right device to the right patient at the right time.

Randomized Controlled Trial of a Novel Communication Device Assessed During Noninvasive Ventilation Therapy.

BACKGROUND: Noninvasive ventilation (NIV), a form of positive airway pressure (PAP) therapy, is the standard of care for various forms of acute respiratory failure (ARF). Communication impairment is a side effect of NIV, impedes patient care, contributes to distress and intolerance, and potentially increases intubation rates. This study aimed to evaluate communication impairment during CPAP therapy and demonstrate communication device improvement with a standardized protocol. RESEARCH QUESTION: How does an oronasal mask affect communication intelligibility? How does use of an NIV communication device change this communication intelligibility? STUDY DESIGN AND METHODS: A single-center randomized controlled trial (36 outpatients with OSA on CPAP therapy) assessed exposure to CPAP 10 cm H2O and PAP communication devices (SPEAX, Ataia Medical). Communication impairment was evaluated by reading selected words and sentences for partners to record and were tabulated as %words correct. Each outpatient-partner pair performed three assessments: (1) baseline (conversing normally), (2) mask baseline (conversing with PAP), and (3) randomized to functioning device (conversing with PAP and device) or sham device. After each stage, both outpatients and partners completed Likert surveys regarding perceived intelligibility and comfort. RESULTS: While conversing with PAP, word and sentence intelligibility decreased relatively by 52% (87% vs 41%) and relatively by 57% (94% vs 40%), respectively, compared with normal conversation. Word and sentence intelligibility in the intervention arm increased relatively by 75% (35% vs 61%; P < .001) and by 126% (33% vs 76%; P < .001) higher than the control arm, respectively. The device improved outpatient-perceived PAP comfort relatively by 233% (15% vs 50%, P = .042) and partner-perceived comfort by relatively 245% (20% vs 69%, P = .0074). INTERPRETATION: Use of this PAP communication device significantly improves both intelligibility and comfort. This is one of the first studies quantifying communication impairment during PAP delivery. TRIAL REGISTRY: ClinicalTrials.gov; No.: NCT03795753; URL: www.clinicaltrials.gov.

A network meta-analysis of different positive airway pressure interventions in obesity hypoventilation syndrome.

Continuous positive airway pressure (CPAP) and different types of non-invasive ventilation (NIV) have been studied in obesity hypoventilation syndrome such as bi-level PAP with back-up rate (BPAP-BUR), BPAP without BUR, and the new hybrid devices that target a pre-set volume by adjustment of pressure support (VT-PS). Although several studies have compared one PAP intervention with the other, none has compared all four in a head-to-head design, which formed the basis of this network meta-analysis. PubMed and Web of Science were searched for potentially includable randomised active comparator trials. Changes in partial pressure of carbon dioxide (PaCO2 ) and Epworth Sleepiness Score (ESS) were the primary outcomes of interest. Network meta-analysis was done in R program using the 'frequentist' framework. A total of seven trials were included. Only VT-PS and BPAP-BUR showed statistically significant reductions in PaCO2 compared to control, with no significant inter-PAP differences except for the comparison between VT-PS and CPAP. Only VT-PS showed a statistically significant improvement in ESS as compared to control, with no other significant inter-PAP differences. P-score ranking (based on effect size and standard errors) and Hasse diagram ranked VT-PS and BPAP as superior to other PAPs for both primary outcomes. There were no significant differences between the different PAP interventions for hospital or emergency department admissions. The results of this network meta-analysis suggest superiority of VT-PS and BPAP over other PAP interventions at least for daytime hypercapnia and subjective daytime somnolence.

Improving the performance of peripheral arterial tonometry-based testing for the diagnosis of obstructive sleep apnea.

Outside sleep laboratory settings, peripheral arterial tonometry (PAT, eg, WatchPat) represents a validated modality for diagnosing obstructive sleep apnea (OSA). We have shown before that the accuracy of home sleep apnea testing by WatchPat 200 devices in diagnosing OSA is suboptimal (50%-70%). In order to improve its diagnostic performance, we built several models that predict the main functional parameter of polysomnography (PSG), Apnea Hypopnea Index (AHI). Participants were recruited in our Sleep Center and underwent concurrent in-laboratory PSG and PAT recordings. Statistical models were then developed to predict AHI by using robust functional parameters from PAT-based testing, in concert with available demographic and anthropometric data, and their performance was confirmed in a random validation subgroup of the cohort. Five hundred synchronous PSG and WatchPat sets were analyzed. Mean diagnostic accuracy of PAT was improved to 67%, 81% and 85% in mild, moderate-severe or no OSA, respectively, by several models that included participants' age, gender, neck circumference, body mass index and the number of 4% desaturations/hour. WatchPat had an overall accuracy of 85.7% and a positive predictive value of 87.3% in diagnosing OSA (by predicted AHI above 5). In this large cohort of patients with high pretest probability of OSA, we built several models based on 4% oxygen desaturations, neck circumference, body mass index and several other variables. These simple models can be used at the point-of-care, in order to improve the diagnostic accuracy of the PAT-based testing, thus ameliorating the high rates of misclassification for OSA presence or disease severity.

Consequences and Solutions for the Impact of Communication Impairment on Noninvasive Ventilation Therapy for Acute Respiratory Failure: A Focused Review.

OBJECTIVES: With over 2 million cases of acute respiratory failure in the United States per year, noninvasive ventilation has become a leading treatment modality, often supplanting invasive mechanical ventilation as the initial treatment of choice. Most acute respiratory failure patients use a full face (oronasal) mask with noninvasive ventilation, which is known to impair communication, but its popularity and benefit has led many providers to accept the communication impairment. Medical staff periodically remove masks to communicate with patients, but patients are often limited to short utterances and risk lung derecruitment upon removal of positive pressure. These problems can lead to noninvasive ventilation failure, which is often linked to worse outcomes than first initiating invasive mechanical ventilation and can lead to increased hospitalization costs. DATA SOURCES: We searched MEDLINE and Google Scholar for "speech," "communication," "impairment," "failure," "complications," "NIPPV," "NIV," and "noninvasive ventilation." STUDY SELECTION: We included articles with patients in acute respiratory failure. We excluded articles for patients using noninvasive ventilation therapy for obstructive sleep apnea. DATA SYNTHESIS: Communication impairment has been associated with increasing noninvasive ventilation anxiety (odds ratio, 1.25). Of patients using noninvasive ventilation, 48% require early discontinuation, 22% refuse noninvasive ventilation, and 9% are ultimately intubated. Improvements to communication have been shown to reduce fear and anxiety in invasive mechanical ventilation patients. Analogous communication problems exist with effective solutions in other fields, such as fighter pilot masks, that can be easily implemented to enhance noninvasive ventilation patient care, increase adherence to noninvasive ventilation treatment, and improve patient outcomes. CONCLUSIONS: Communication impairment is an underappreciated cause of noninvasive ventilation complications and failure and requires further characterization. Analogous solutions-such as throat microphones and mask-based microphones-that can be easily implemented show potential as cost-effective methods to reduce noninvasive ventilation failure.

Performance of peripheral arterial tonometry-based testing for the diagnosis of obstructive sleep apnea in a large sleep clinic cohort.

STUDY OBJECTIVES: Peripheral arterial tonometry (PAT)-based technology represents a validated portable monitoring modality for the diagnosis of OSA. We assessed the diagnostic accuracy of PAT-based technology in a large point-of-care cohort of patients studied with concurrent polysomnography (PSG). METHODS: During study enrollment, all participants suspected to have OSA and tested by in-laboratory PSG underwent concurrent PAT device recordings. RESULTS: Five hundred concomitant PSG and WatchPat tests were analyzed. Median (interquartile range) PSG AHI was 18 (8-37) events/h and PAT AHI3% was 25 (12-46) events/h. Average bias was + 4 events/h. Diagnostic concordance was found in 42%, 41%, and 83% of mild, moderate, and severe OSA, respectively (accuracy = 53%). Among patients with PAT diagnoses of moderate or severe OSA, 5% did not have OSA and 19% had mild OSA; in those with mild OSA, PSG showed moderate or severe disease in 20% and no OSA in 30% of patients (accuracy = 69%). On average, using a 3% desaturation threshold, WatchPat overestimated disease prevalence and severity (mean + 4 events/h) and the 4% threshold underestimated disease prevalence and severity by -6 events/h. CONCLUSIONS: Although there was an overall tendency to overestimate the severity of OSA, a significant percentage of patients had clinically relevant misclassifications. As such, we recommend that patients without OSA or with mild disease assessed by PAT undergo repeat in-laboratory PSG. Optimized clinical pathways are urgently needed to minimize therapeutic decisions instituted in the presence of diagnostic uncertainty.

Development and Reporting of Prediction Models: Guidance for Authors From Editors of Respiratory, Sleep, and Critical Care Journals.

Prediction models aim to use available data to predict a health state or outcome that has not yet been observed. Prediction is primarily relevant to clinical practice, but is also used in research, and administration. While prediction modeling involves estimating the relationship between patient factors and outcomes, it is distinct from casual inference. Prediction modeling thus requires unique considerations for development, validation, and updating. This document represents an effort from editors at 31 respiratory, sleep, and critical care medicine journals to consolidate contemporary best practices and recommendations related to prediction study design, conduct, and reporting. Herein, we address issues commonly encountered in submissions to our various journals. Key topics include considerations for selecting predictor variables, operationalizing variables, dealing with missing data, the importance of appropriate validation, model performance measures and their interpretation, and good reporting practices. Supplemental discussion covers emerging topics such as model fairness, competing risks, pitfalls of "modifiable risk factors", measurement error, and risk for bias. This guidance is not meant to be overly prescriptive; we acknowledge that every study is different, and no set of rules will fit all cases. Additional best practices can be found in the Transparent Reporting of a multivariable prediction model for Individual Prognosis Or Diagnosis (TRIPOD) guidelines, to which we refer readers for further details.

Obstructive sleep apnea, sleep symptoms, and their association with cardiovascular disease.

OBJECTIVES: To determine the frequency of obstructive sleep apnea (OSA), insomnia, restless legs, and other sleep symptoms in patients with cardiovascular disease and the association of these sleep disorders with quantitative cardiovascular measures. METHODS: Study design was a cross-sectional survey and retrospective chart review. A questionnaire containing validated sleep symptoms was distributed to 202 patients with cardiovascular disease at a tertiary referral cardiology clinic. Following a focused review of these patients' medical charts, their questionnaire responses were examined for associations with clinical cardiovascular parameters. RESULTS: Twenty-one percent of patients reported a prior diagnosis of OSA. A total of 115 patients (60%) had at least one additional sleep symptom. Clinically significant insomnia was significantly associated with heart disease (relative risk [RR] = 1.5, confidence interval [CI] = 1.1 to 2.1), prior myocardial infarction or cerebrovascular accident (RR = 2.1, CI = 1.2 to 3.6), and heart failure (RR = 2.2, CI = 1.3 to 3.8). Left ventricular ejection fraction was significantly associated with insomnia by Insomnia Severity Index (ß = -0.52, CI = -0.89 to -0.13). CONCLUSION: The frequency of OSA in patients in this tertiary cardiology clinic was higher than the general population in the United States, with the majority of patients experiencing at least one sleep symptom. Insomnia symptoms were shown to be associated with multiple cardiovascular measures, including left ventricular ejection fraction. These findings imply an interwoven relationship between cardiovascular and sleep symptoms as captured by validated sleep questionnaires. LEVEL OF EVIDENCE: IV Laryngoscope, 130:1595-1602, 2020.

Surgical Treatment of OSA on Cardiovascular Outcomes: A Systematic Review.

BACKGROUND: OSA is an increasingly prevalent clinical problem with significant effects on quality of life and cardiovascular risk. Surgical therapy represents an important treatment for those unable to use positive airway pressure. This systematic review examines the available cardiovascular risk reduction data for the surgical treatment of OSA. METHODS: A comprehensive literature search was performed. Articles were included if they met the following criteria: (1) the sample population consisted of adults (age ≥ 18 years); (2) OSA was diagnosed according to a sleep study; (3) surgical intervention was performed for OSA; and (4) one or more physical or biochemical cardiovascular and/or cerebrovascular variables was measured preoperatively and at ≥ 14 days postoperatively. RESULTS: Thirty-three articles were included. The majority of studies were case series and cohort studies (42% and 44%, respectively), with wide-ranging follow-up periods (4 weeks-9 years) and sample sizes (range, 6-10,339; median, 34). The following classes of surgical intervention were examined: pharyngeal surgery (n = 23), tracheostomy (n = 6), maxillomandibular advancement (n = 3), and hypoglossal nerve stimulation (n = 1). In total, 19 outcome measures were assessed. Tracheostomy was most consistently associated with improvement in cardiovascular end points. Pharyngeal surgeries (eg, uvulopalatopharyngoplasty) were variably associated with improvement in cardiovascular end points. CONCLUSIONS: The published literature examining cardiovascular end points following surgical treatment of OSA is limited and generally of poor quality. However, available data from mainly small and observational studies suggest that surgical treatment of OSA may provide improvement in some cardiovascular end points. Larger, randomized, and prospective trials with more rigorous study designs are needed. TRIAL REGISTRY: PROSPERO International Prospective Register of Systemic Reviews (PROSPERO 42016040120).

Sleep-Disordered Breathing and Cardiovascular Correlates in College Football Players.

This study sought to determine the cardiovascular physiologic correlates of sleep-disordered breathing (SDB) in American-style football (ASF) participants using echocardiography, vascular applanation tonometry, and peripheral arterial tonometry. Forty collegiate ASF participants were analyzed at pre- and postseason time points with echocardiography and vascular applanation tonometry. WatchPAT (inclusive of peripheral arterial tonometry) used to assess for SDB was then performed at the postseason time point. Twenty-two of 40 (55%) ASF participants demonstrated SDB with an apnea-hypopnea index (pAHI) ≥5. ASF participants with SDB were larger (109 ± 20 vs 92 ± 14 kg, p = 0.004) and more likely linemen position players (83% vs 50%, p = 0.03). Compared with those without SDB, ASF participants with SDB demonstrated relative impairments in left ventricular diastolic and vascular function as reflected by lower lateral e' (14 ± 3 vs 17 ± 3 cm/s, p = 0.007) and septal e' (11 ± 2 vs 13 ± 2 cm/s, p = 0.009) tissue velocities and higher pulse wave velocity (5.4 ± 0.9 vs 4.8 ± 0.5 m/s, p = 0.02). In the total cohort, there were significant positive correlations between pAHI and pulse wave velocity (r = 0.42, p = 0.008) and inverse correlations between pAHI and the averaged e' tissue velocities (r = -0.42, p = 0.01). In conclusion, SDB is highly prevalent in youthful collegiate ASF participants and associated with relative impairments in cardiac and vascular function. Targeted efforts to identify youthful populations with SDB, including ASF participants, and implement SDB treatment algorithms, represent important future clinical directives.

Validated Measures of Insomnia, Function, Sleepiness, and Nasal Obstruction in a CPAP Alternatives Clinic Population.

STUDY OBJECTIVES: Although efficacious in the treatment of obstructive sleep apnea (OSA), continuous positive airway pressure (CPAP) can be difficult to tolerate, with long-term adherence rates approaching 50%. CPAP alternatives clinics specialize in the evaluation and treatment of CPAP-intolerant patients; yet this population has not been studied in the literature. To better understand these patients, we sought to assess insomnia, sleep-related functional status, sleepiness, and nasal obstruction, utilizing data from validated instruments. METHODS: After approval from the Emory University Institutional Review Board, a retrospective chart review was performed from September 2015 to September 2016 of new patient visits at the Emory CPAP alternatives clinic. Patient demographics and responses were recorded from the Insomnia Severity Index, Functional Outcomes of Sleep Questionnaire-10 (FOSQ-10), Epworth Sleepiness Scale, and Nasal Obstruction Symptom Evaluation questionnaires. RESULTS: A total of 172 patients were included, with 81% having moderate-severe OSA. Most of the patients demonstrated moderate-severe clinical insomnia and at least moderate nasal obstruction. FOSQ-10 scores indicated sleep-related functional impairment in 88%. However, most patients did not demonstrate excessive daytime sleepiness. CONCLUSION: This patient population demonstrates significant symptomatology and functional impairment. Because of the severity of their OSA, they are at increased risk of complications. In order to mitigate the detrimental effects of OSA, these significantly impacted patients should be identified and encouraged to seek CPAP alternatives clinics that specialize in the treatment of this population.

Legal and Regulatory Aspects of Sleep Disorders.

Sleep disorders may interact with the law, making awareness important. Insufficient sleep and obstructive sleep apnea (OSA) are prevalent and associated with excessive sleepiness. Patients with excessive sleepiness may have civil or criminal liability if they fall asleep and cause a motor vehicle accident. Awareness of screening and treatment of OSA is increasing in certain industries. Parasomnia associated sleep-related violence represents a challenge to clinicians, who may be called on to consider parasomnia as a contributing, mitigating, or exculpatory factor in criminal proceedings. Improving access to sleep medicine care is an important aspect in reducing the consequences of sleep disorders.