Association Between Sleep Apnea Treatment and Health Care Resource Use in Patients With Atrial Fibrillation.

BACKGROUND: Obstructive sleep apnea (OSA) contributes to the generation, recurrence, and perpetuation of atrial fibrillation, and it is associated with worse outcomes. Little is known about the economic impact of OSA therapy in atrial fibrillation. This retrospective cohort study assessed the impact of positive airway pressure (PAP) therapy adherence on health care resource use and costs in patients with OSA and atrial fibrillation. METHODS AND RESULTS: Insurance claims data for ≥1 year before sleep testing and 2 years after device setup were linked with objective PAP therapy use data. PAP adherence was defined from an extension of the US Medicare 90-day definition. Inverse probability of treatment weighting was used to create covariate-balanced PAP adherence groups to mitigate confounding. Of 5867 patients (32% women; mean age, 62.7 years), 41% were adherent, 38% were intermediate, and 21% were nonadherent. Mean±SD number of all-cause emergency department visits (0.61±1.21 versus 0.77±1.55 [P=0.023] versus 0.95±1.90 [P<0.001]), all-cause hospitalizations (0.19±0.69 versus 0.24±0.72 [P=0.002] versus 0.34±1.16 [P<0.001]), and cardiac-related hospitalizations (0.06±0.26 versus 0.09±0.41 [P=0.023] versus 0.10±0.44 [P=0.004]) were significantly lower in adherent versus intermediate and nonadherent patients, as were all-cause inpatient costs ($2200±$8054 versus $3274±$12 065 [P=0.002] versus $4483±$16 499 [P<0.001]). All-cause emergency department costs were significantly lower in adherent and intermediate versus nonadherent patients ($499±$1229 and $563±$1292 versus $691±$1652 [P<0.001 and P=0.002], respectively). CONCLUSIONS: These data suggest clinical and economic benefits of PAP therapy in patients with concomitant OSA and atrial fibrillation. This supports the value of diagnosing and managing OSA and highlights the need for strategies to enhance PAP adherence in this population.

Mild obstructive sleep apnoea in females: post hoc analysis of the MERGE randomised controlled trial.

Background: A post hoc analysis of the MERGE trial was conducted, to investigate whether sex differences are evident at the mildest end of the disease spectrum, for symptoms associated with obstructive sleep apnoea (OSA) and the response to continuous positive airway pressure (CPAP) treatment. Methods: MERGE participants with mild OSA (apnoea-hypopnoea index 5-15 events·h-1; American Academy of Sleep Medicine 2012 criteria) were randomised to either CPAP plus standard care (sleep hygiene counselling) or standard care alone for 3 months. Quality of life (QoL) was measured by questionnaires completed before and after the 3 months. This post hoc analysis of participants of the MERGE trial compared the symptom presentation, and response to CPAP, between the sexes. Results: 233 patients were included; 71 (30%) were female. Females were more symptomatic at baseline in all QoL questionnaires. Specifically, females had lower 36-item Short-Form Health Survey (SF-36) Vitality scores (mean±sd 39.1±10.1 versus 44.8±10.3) and higher Epworth Sleepiness Scale (ESS) scores (mean±sd 11.0±4.2 versus 9.5±4.4). Both sexes experienced snoring, but more females reported fatigue and more males reported witnessed apnoeas. All symptoms improved with CPAP for both sexes; however, females had larger improvements in SF-36 Vitality scores, which was the primary outcome of the MERGE trial (mean change 9.4 (95% CI 6.8-12.0) versus 6.0 (95% CI 4.3-7.7); p=0.034), and ESS (mean change -4.1 (95% CI -5.1- -3.0) versus -2.5 (95% CI -3.1- -1.8); p=0.015), after adjustment for baseline scores and CPAP usage. Conclusions: Sex differences are apparent in patients with mild OSA. Females experience worse QoL symptoms than males at presentation to the sleep clinic; however, these improve significantly with CPAP treatment.

Effects of Adaptive Servo-Ventilation on Quality of Life: The READ-ASV Registry.

Rationale: Adaptive servo-ventilation (ASV) effectively treats sleep-disordered breathing, including central sleep apnea (CSA) and coexisting obstructive sleep apnea (OSA).Objectives: The prospective, multicenter European READ-ASV (Registry on the Treatment of Central and Complex Sleep-Disordered Breathing with Adaptive Servo-Ventilation) registry investigated the effects of first-time ASV therapy on disease-specific quality of life (QoL).Methods: The registry enrolled adults with CSA with or without OSA who had ASV therapy prescribed between September 2017 and March 2021. The primary endpoint was change in disease-specific QoL (Functional Outcomes of Sleep Questionnaire [FOSQ]) score between baseline and 12-month follow-up. Sleepiness determined using the Epworth Sleepiness Scale (ESS) score was a key secondary outcome. For subgroup analysis, participants were classified as symptomatic (FOSQ score < 17.9 and/or ESS score > 10) or asymptomatic (FOSQ score ⩾ 17.9 and/or ESS score ⩽ 10).Results: A total of 801 individuals (age, 67 ± 12 yr; 14% female; body mass index, 31 ± 5 kg/m2; apnea-hypopnea index, 48 ± 22/h) were enrolled; analyses include those with paired baseline and follow-up data. After 12 ± 3 months on ASV, median (interquartile range) FOSQ score had increased significantly from baseline (+0.8 [-0.2 to 2.2]; P < 0.001; n = 499). This was due to a significantly increased FOSQ score in symptomatic participants (+1.69 [0.38 to 3.05]), with little change in asymptomatic individuals (+0.11 [-0.39 to 0.54]). The median ESS score also improved significantly from baseline during ASV (-2.0 [-5.0 to 0.0]; P < 0.001).Conclusions: ASV treatment of CSA with or without coexisting OSA was associated with improvements in disease-specific QoL and daytime sleepiness, especially in individuals with sleep-disordered breathing symptoms before therapy initiation. These improvements in patient-reported outcomes support the use of ASV in this population.

The OSA patient journey: pathways for diagnosis and treatment among commercially insured individuals in the United States.

STUDY OBJECTIVES: The aims of this study were to characterize obstructive sleep apnea (OSA) care pathways among commercially insured individuals in the United States and to investigate between-groups differences in population, care delivery, and economic aspects. METHODS: We identified adults with OSA using a large, national administrative claims database (January 1, 2016-February 28, 2020). Inclusion criteria included a diagnostic sleep test on or within ≤ 12 months of OSA diagnosis (index date) and 12 months of continuous enrollment before and after the index date. Exclusion criteria included prior OSA treatment or central sleep apnea. OSA care pathways were identified using sleep testing health care procedural health care common procedure coding system/current procedural terminology codes then selected for analysis if they were experienced by ≥ 3% of the population and assessed for baseline demographic/clinical characteristics that were also used for model adjustment. Primary outcome was positive airway pressure initiation rate; secondary outcomes were time from first sleep test to initiation of positive airway pressure, sleep test costs, and health care resource utilization. Associations between pathway type and time to treatment initiation were assessed using generalized linear models. RESULTS: Of 86,827 adults with OSA, 92.1% received care in 1 of 5 care pathways that met criteria: home sleep apnea testing (HSAT; 30.8%), polysomnography (PSG; 23.6%), PSG-Titration (19.8%), Split-night (14.8%), and HSAT-Titration (3.2%). Pathways had significantly different demographic and clinical characteristics. HSAT-Titration had the highest positive airway pressure initiation rate (84.6%) and PSG the lowest (34.4%). After adjustments, time to treatment initiation was significantly associated with pathway (P < .0001); Split-night had shortest duration (median, 28 days), followed by HSAT (36), PSG (37), PSG-Titration (58), and HSAT-Titration (75). HSAT had the lowest sleep test costs and health care resource utilization. CONCLUSIONS: Distinct OSA care pathways exist and are associated with differences in population, care delivery, and economic aspects. CITATION: Wickwire EM, Zhang X, Munson SH, et al. The OSA patient journey: pathways for diagnosis and treatment among commercially insured individuals in the United States. J Clin Sleep Med. 2024;20(4):505-514.

CPAP resumption after a first termination and impact on all-cause mortality in France.

BACKGROUND: Continuation of continuous positive airway pressure (CPAP) therapy after initial prescription has been shown to reduce all-cause mortality versus therapy termination. However, there is a lack of data on the rates and impact of resuming CPAP in patients with obstructive sleep apnoea (OSA). This analysis determined the prevalence of CPAP resumption in the year after termination, characterised determinants of CPAP resumption, and examined the impact of CPAP resumption on all-cause mortality. METHODS: French national health insurance reimbursement system data for adults aged ≥18 years were used. CPAP prescription was identified by specific treatment codes. Patients who resumed CPAP after first therapy termination and continued to use CPAP for 1 year were matched with those who resumed CPAP then terminated therapy for a second time. RESULTS: Out of 103 091 individuals with a first CPAP termination, 26% resumed CPAP over the next 12 months, and 65% of these were still using CPAP 1 year later. Significant predictors of CPAP continuation after resumption included male sex, hypertension and CPAP prescription by a pulmonologist. In the matched population, the risk of all-cause death was 38% lower in individuals who continued using CPAP after therapy resumption versus those who had a second therapy discontinuation (hazard ratio 0.62, 95% CI 0.48-0.79; p=0.0001). CONCLUSION: These data suggest that individuals with OSA who fail initial therapy with CPAP should be offered a second trial with the device to ensure that effective therapy is not withheld from those who might benefit.

Global Burden of Chronic Obstructive Pulmonary Disease Through 2050.

Importance: Chronic obstructive pulmonary disease (COPD) is a respiratory condition that is associated with significant health and economic burden worldwide. Previous studies assessed the global current-day prevalence of COPD, but to better facilitate resource planning and intervention development, long-term projections are needed. Objective: To assess the global burden of COPD through 2050, considering COPD risk factors. Design, Setting, and Participants: In this modeling study, historical data on COPD prevalence was extracted from a recent meta-analysis on 2019 global COPD prevalence, and 2010 to 2018 historical prevalence was estimated using random-effects meta-analytical models. COPD risk factor data were obtained from the Global Burden of Disease database. Main Outcomes and Measures: To project global COPD prevalence to 2050, generalized additive models were developed, including smoking prevalence, indoor and outdoor air pollution, and development indices as predictors, and stratified by age, sex, and World Bank region. Results: The models estimated that the number of COPD cases globally among those aged 25 years and older will increase by 23% from 2020 to 2050, approaching 600 million patients with COPD globally by 2050. Growth in the burden of COPD was projected to be the largest among women and in low- and middle-income regions. The number of female cases was projected to increase by 47.1% (vs a 9.4% increase for males), and the number of cases in low- and middle-income regions was expected to be more than double that of high-income regions by 2050. Conclusions and Relevance: In this modeling study of future COPD burden, projections indicated that COPD would continue to affect hundreds of millions of people globally, with disproportionate growth among females and in low-middle income regions through 2050. Further research, prevention, and advocacy are needed to address these issues so that adequate preparation and resource allocation can take place.

Positive Airway Pressure Therapy Adherence and Health Care Resource Use in Patients With Obstructive Sleep Apnea and Heart Failure With Preserved Ejection Fraction.

Background Obstructive sleep apnea (OSA) is common in heart failure with preserved ejection fraction (HFpEF). However, current evidence is equivocal regarding the potential benefits of treating OSA with positive airway pressure (PAP) therapy in HFpEF. This study assessed the association between adherence to PAP therapy and health care resource use in patients with OSA and HFpEF. Methods and Results Administrative insurance claims data linked with objective PAP therapy usage data from patients with OSA and HFpEF were used to determine associations between PAP adherence and a composite outcome including hospitalizations and emergency room visits. One-year PAP adherence was based on an adapted US Medicare definition. Propensity score methods were used to create groups with similar characteristics across PAP adherence levels. The study cohort included 4237 patients (54.0% female, mean age 64.1 years); 40% were considered adherent to PAP therapy (30% intermediate adherent, 30% nonadherent). In the matched cohort, PAP-adherent patients had fewer health care resource use visits than nonadherent patients, a 57% decrease in hospitalizations, and a 36% decrease in emergency room visits versus the year before PAP initiation. Total health care costs were lower in adherent patients than nonadherent patients ($12 732 versus $15 610, P<0.001). Outcomes for intermediately adherent patients were most similar to those for nonadherent patients. Conclusions Treating OSA with PAP therapy in patients with HFpEF was associated with a reduction in health care resource use. These data highlight the importance of managing concomitant OSA in patients with HFpEF, and the need for strategies to enhance PAP adherence in this population.

Pilot study of positive airway pressure usage, patient journey and program engagement for users of a digital obstructive sleep apnea program.

Purpose: This single-arm, decentralized pilot study assessed patient journey, positive airway pressure (PAP) usage and program satisfaction for users of an entirely virtual telemedicine program for obstructive sleep apnea (OSA) diagnosis and management. This analysis focuses specifically on the subset of participants in the program who were diagnosed with OSA and prescribed PAP therapy. Methods: The Verily Clinical Studies Platform was used for virtual screening, consent, and enrolling eligible patients from North Carolina and Texas. After completing the virtual OSA diagnosis process, participants diagnosed with OSA and prescribed PAP therapy downloaded the program's mobile app. The app featured tools such as educational content, live coaching support, and motivational enhancement. Results: Of the patients included in this analysis (N = 105), the majority were female (58%), and white (90%). The mean time from first televisit to PAP initiation was 29.2 (SD 12.8) days and f 68 out of the 105 patients (65%) reached 90-day adherence. On average, patients used their PAP device for 4.4 h per day, and 5.4 h on days used. Engagement with the app was associated with higher rates of PAP adherence. Adherent individuals used the mobile app 52 out of the 90 days on average, compared to non-adherent individuals who used the app on 35 out of the 90 days on average (p = 0.0003). Conclusions: All of the 105 patients in this program diagnosed with OSA and prescribed PAP therapy were able to efficiently complete the entire OSA diagnostic pathway. The majority of these individuals also were able to adhere to their prescribed PAP therapy and had clinically meaningful PAP usage rates over the 90 days of therapy. Future studies might further evaluate the impact of this type of end-to-end virtual program on longer-term adherence and clinical outcomes over time. Clinical Trial Registration: https://clinicaltrials.gov/ct2/show/NCT04599803?term=NCT04599803&draw=2&rank=1, identifier NCT04599803.

Positive Airway Pressure Adherence and Health Care Resource Utilization in Patients With Obstructive Sleep Apnea and Heart Failure With Reduced Ejection Fraction.

Background Obstructive sleep apnea (OSA) is a common comorbidity in patients with heart failure, although current evidence is equivocal regarding the potential benefits of treating OSA with positive airway pressure (PAP) therapy in patients with heart failure. This study assessed the impact of adherence to PAP therapy on health care resource utilization in patients with OSA and heart failure with reduced ejection fraction. Methods and Results Administrative insurance claims data linked with objective PAP therapy use data from patients with OSA and heart failure with reduced ejection fraction were used to determine associations between PAP adherence and a composite outcome of hospitalizations and emergency room visits. One-year PAP adherence was based on an adapted US Medicare definition. Propensity score methods were used to create groups with similar characteristics across PAP adherence levels. The study cohort included 3182 patients (69.9% male, mean age 59.7 years); 39% were considered adherent to PAP therapy (29% intermediate adherent, 31% nonadherent). One year after PAP initiation, adherent patients had fewer composite visits than matched nonadherent patients, driven by a 24% reduction in emergency room visits for adherent patients. Composite visit costs were lower in adherent versus nonadherent patients ($3500 versus $5879, P=0.031), although total health care costs were not statistically different ($13 028 versus $14 729, P=0.889). Conclusions PAP therapy adherence in patients with OSA with heart failure with reduced ejection fraction was associated with a reduction in health care resource utilization. This suggests that greater emphasis should be placed on diagnosing and effectively treating OSA with PAP in patients with heart failure with reduced ejection fraction.

Relationship between Self-reported Sleepiness and Positive Airway Pressure Treatment Adherence in Obstructive Sleep Apnea.

Rationale: Positive airway pressure (PAP) is the first-choice treatment for obstructive sleep apnea (OSA). However, its real-world effectiveness is often questioned because of usage issues. The relationship between patient sleepiness and PAP usage has been assessed in relatively small and selected populations within the research context. Objectives: To assess the impact of patient-reported sleep outcomes, particularly self-reported sleepiness and its change during therapy, on PAP usage in the real-world setting. Methods: Deidentified data for U.S.-based patients receiving PAP therapy were examined. Eligible patients were registered in the myAir app and provided self-reported sleepiness at baseline and after 7, 14, 21, and 28 days of PAP between November 2019 and April 2020. Results: A total of 95,397 registered patients met all eligibility criteria and were included in the analysis (mean age, 49.6 ± 13.0 yr; 61.6% male). Daytime sleepiness was the most common reason for PAP therapy initiation (57.1% of patients), and 42.2% of all patients had self-reported moderate to severe OSA. Self-reported sleepiness improved with PAP therapy in most patients over the assessment period, with 62.1% of patients reporting "no" or "slight" sleepiness at Day 28. There was a dose-dependent association between improvement in self-reported sleepiness at Day 28 and PAP usage, and this finding was maintained at Day 360. Self-reported sleepiness at Day 28 was associated with achieving U.S. Centers for Medicare & Medicaid Services compliance at 90 days (approximately 90% for those with no or slight sleepiness vs. <70% for those with residual very or extreme sleepiness); average daily PAP usage over 360 days was ⩾5.0 and ⩽3.7 hours, respectively, for those with no or slight versus very or extreme sleepiness. Conclusions: This study demonstrates the feasibility of capturing patient-reported outcomes via a digital platform. Patient-reported outcomes appear to be associated with PAP usage, especially self-reported sleepiness and its response to therapy. Capturing patient-reported outcomes using digital solutions during the course of treatment has the potential to enhance patient outcomes by providing actionable insights.

Dose-Response Relationship between Obstructive Sleep Apnea Therapy Adherence and Healthcare Utilization.

Rationale: Clear definition of optimal positive airway pressure therapy usage in patients with obstructive sleep apnea is not possible because of scarce data on the relationship between usage hours and major clinical outcomes. Objective: To investigate the dose-response relationship between positive airway pressure usage and healthcare resource utilization and determine the minimum device usage required for benefit. Methods: A linked data set combined deidentified payer-sourced administrative medical/pharmacy claims data from more than 100 U.S. health plans and individual patient positive airway pressure usage data. Eligible adults (age ⩾18 yr) had a new obstructive sleep apnea diagnosis between June 2014 and April 2018. All received positive airway pressure therapy (AirSense 10; ResMed) with claims data for ⩾1 year before, and 2 years after, device setup. Healthcare resource utilization was determined on the basis of the number of all-cause hospitalizations and emergency room visits over 3, 12, and 24 months after positive airway pressure initiation. Results: Data from 179,188 patients showed a clear dose-response relationship between daily positive airway pressure usage and healthcare utilization. Minimum device usage required for benefit was 1-3 hours per night. There was a statistically significant decrease in hospitalizations and emergency room visits at all time points (all Ps < 0.0001) with increasing positive airway pressure usage. Each additional hour of usage per night decreased hospitalizations and emergency room visits by 5-10% and 5-7%, respectively. Conclusions: These data provide compelling evidence for a dose-response relationship between positive airway pressure usage and healthcare utilization, with benefits seen even when usage was as low as 1-2 hours per night.

Association between positive airway pressure therapy adherence and health care resource utilization in patients with obstructive sleep apnea and type 2 diabetes in the United States.

STUDY OBJECTIVES: There is a complex interplay between obstructive sleep apnea (OSA) and type 2 diabetes. There are minimal data regarding the effects of treating OSA with positive airway pressure (PAP) therapy on outcomes and health care resource utilization (HCRU) in patients with OSA and type 2 diabetes. We investigated the impact of PAP adherence on HCRU and costs in this population. METHODS: A retrospective analysis was conducted with a cohort of OSA patient from a US administrative claims dataset linked to objective device data (AirView, ResMed Corp., San Diego, California). Propensity score matching was used to control for potential imbalance in baseline covariates between PAP-adherent and -nonadherent patients. Newly diagnosed patients with OSA aged ≥ 18 years with type 2 diabetes were included. PAP adherence was defined as meeting Centers for Medicare and Medicaid Services compliance criteria in all 8 90-day periods over 2 years. HCRU was based on the number of all-cause doctor visits, emergency room visits, inpatient hospitalizations, and PAP equipment and supplies. RESULTS: In years 1 and 2 of PAP therapy, HCRU was significantly lower in adherent vs nonadherent patients (number/patient for emergency room visits 0.68 ± 1.47 vs 0.99 ± 1.91 [year 1], 0.69 ± 1.43 vs 0.95 ± 1.89 [year 2]; for hospitalizations 0.16 ± 0.58 vs 0.22 ± 0.62 [year 1], 0.15 ± 0.51 vs 0.21 ± 0.74 [year 2]; all P < .001). Changes in estimated total 24-month payments were higher for nonadherent patients ($2,282, 95% confidence interval: $1,368, $3,205). CONCLUSIONS: Consistent use of PAP therapy over 2 years was associated with decreased HCRU in patients with OSA and type 2 diabetes, strongly suggesting a role for screening and treating OSA in type 2 diabetes. CITATION: Sterling KL, Cistulli PA, Linde-Zwirble W, et al. Association between positive airway pressure therapy adherence and health care resource utilization in patients with obstructive sleep apnea and type 2 diabetes in the United States. J Clin Sleep Med. 2023;19(3):563-571.

Impact of Positive Airway Pressure Therapy Adherence on Outcomes in Patients with Obstructive Sleep Apnea and Chronic Obstructive Pulmonary Disease.

Rationale: The co-occurrence of obstructive sleep apnea and chronic obstructive pulmonary disease, termed overlap syndrome, has a poor prognosis. However, data on positive airway pressure (PAP) treatments and their impact on outcomes and costs are lacking. Objectives: This retrospective observational study investigated the effects of PAP on health outcomes, resource usage, and costs in patients with overlap syndrome. Methods: Deidentified adjudicated claims data for patients with overlap syndrome in the United States were linked to objectively measured PAP user data. Patients were considered adherent to PAP therapy if they met Centers for Medicare and Medicaid Services criteria for eight 90-day timeframes from device setup through 2-year follow-up. Propensity score matching was used to create comparable groups of adherent and nonadherent patients. Healthcare resource usage was based on the number of doctor visits, all-cause emergency room visits, all-cause hospitalizations, and PAP equipment and supplies, and proxy costs were obtained. Measurements and Main Results: A total of 6,810 patients were included (mean age, 60.8 yr; 56% female); 2,328 were nonadherent. Compared with the year before therapy, there were significant reductions in the number of emergency room visits, hospitalizations, and severe acute exacerbations during 2 years of PAP therapy in patients who were versus were not adherent (all P < 0.001). This improvement in health status was paralleled by a significant reduction in the associated healthcare costs. Conclusions: PAP usage by patients with overlap syndrome was associated with reduced all-cause hospitalizations and emergency room visits, severe acute exacerbations, and healthcare costs.

Relationship Between CPAP Termination and All-Cause Mortality: A French Nationwide Database Analysis.

BACKGROUND: Randomized controlled trials have failed to demonstrate an effect of CPAP therapy on mortality. However, these studies have a number of important limitations, including low CPAP adherence, patient selection, and a small number of mortality events. RESEARCH QUESTION: What are the effects of CPAP therapy termination in the first year on all-cause mortality in patients with OSA from the Nationwide Claims Data Lake for Sleep Apnea study? STUDY DESIGN AND METHODS: Data from the Système National des Données de Santé (SNDS) database, the French national health insurance reimbursement system, for all new CPAP users ≥ 18 years of age were analyzed. The SNDS contains comprehensive, individualized, and anonymized data on health spending reimbursements for > 99% of all individuals living in France. OSA diagnosis was based on specific disease codes, whereas CPAP prescription was identified using specific treatment method codes. CPAP therapy termination was defined as the cessation of CPAP reimbursements triggered by the respiratory physician or sleep specialist in charge of follow-up. Patients who terminated therapy in the first year were propensity score matched with those who continued to use CPAP. The primary outcome was all-cause mortality. Three-year survival was visualized using Kaplan-Meier curves. Contributors to mortality also were determined. RESULTS: Data from two matched groups each including 88,007 patients were included (mean age, 60 years; 64% men). Continuation of CPAP therapy was associated with a significantly lower risk of all-cause death compared with CPAP therapy termination (hazard ratio [HR], 0.61; 95% CI, 0.57-0.65; P < .01, log-rank test). Incident heart failure also was less common in patients who continued vs terminated CPAP therapy (HR, 0.77; 95% CI, 0.71-0.82; P < .01). INTERPRETATION: These real-world data from a comprehensive, unbiased database highlight the potential for ongoing use of CPAP treatment to reduce all-cause mortality in patients with OSA.

Assessment of Patient Journey Metrics for Users of a Digital Obstructive Sleep Apnea Program: Single-Arm Feasibility Pilot Study.

BACKGROUND: Despite the importance of diagnosis and treatment, obstructive sleep apnea (OSA) remains a vastly underdiagnosed condition; this is partially due to current OSA identification methods and a complex and fragmented diagnostic pathway. OBJECTIVE: This prospective, single-arm, multistate feasibility pilot study aimed to understand the journey in a nonreferred sample of participants through the fully remote OSA screening and diagnostic and treatment pathway, using the Primasun Sleep Apnea Program (formally, Verily Sleep Apnea Program). METHODS: Participants were recruited online from North Carolina and Texas to participate in the study entirely virtually. Eligible participants were invited to schedule a video telemedicine appointment with a board-certified sleep physician who could order a home sleep apnea test (HSAT) to be delivered to the participant's home. The results were interpreted by the sleep physician and communicated to the participant during a second video telemedicine appointment. The participants who were diagnosed with OSA during the study and prescribed a positive airway pressure (PAP) device were instructed to download an app that provides educational and support-related content and access to personalized coaching support during the study's 90-day PAP usage period. Surveys were deployed throughout the study to assess baseline characteristics, prior knowledge of sleep apnea, and satisfaction with the program. RESULTS: For the 157 individuals who were ordered an HSAT, it took a mean of 7.4 (SD 2.6) days and median 7.1 days (IQR 2.0) to receive their HSAT after they completed their first televisit appointment. For the 114 individuals who were diagnosed with OSA, it took a mean of 13.9 (SD 9.6) days and median 11.7 days (IQR 10.1) from receiving their HSAT to being diagnosed with OSA during their follow-up televisit appointment. Overall, the mean and median time from the first televisit appointment to receiving an OSA diagnosis was 21.4 (SD 9.6) days and 18.9 days (IQR 9.2), respectively. For those who were prescribed PAP therapy, it took a mean of 8.1 (SD 9.3) days and median 6.0 days (IQR 4.0) from OSA diagnosis to PAP therapy initiation. CONCLUSIONS: These results demonstrate the possibility of a highly efficient, patient-centered pathway for OSA workup and treatment. Such findings support pathways that could increase access to care, reduce loss to follow-up, and reduce health burden and overall cost. The program's ability to efficiently diagnose patients who otherwise may have not been diagnosed with OSA is important, especially during a pandemic, as the United States shifted to remote care models and may sustain this direction. The potential economic and clinical impact of the program's short and efficient journey time and low attrition rate should be further examined in future analyses. Future research also should examine how a fast and positive diagnosis experience impacts success rates for PAP therapy initiation and adherence. TRIAL REGISTRATION: ClinicalTrials.gov NCT04599803; https://clinicaltrials.gov/ct2/show/NCT04599803.

Characterizing respiratory parameters, settings, and adherence in real-world patients using adaptive servo ventilation therapy: big data analysis.

STUDY OBJECTIVES: There is minimal guidance around how to optimize inspiratory positive airway pressure (IPAP) levels during use of adaptive servo ventilation (ASV) in clinical practice. This real-world data analysis investigated the effects of IPAP and minimum pressure support settings on respiratory parameters and adherence in ASV-treated patients. METHODS: A United States-based telemonitoring database was queried for patients starting ASV between August 1, 2014 and November 30, 2019. Patients meeting the following criteria were included: United States-based patients aged ≥ 18 years; AirCurve 10 device (ResMed); and ≥ 1 session with usage of ≥ 1 hour in the first 90 days. Key outcomes were mask leak and residual apnea-hypopnea index at different IPAP settings, adherence and therapy termination rates, and respiratory parameters at different minimum pressure support settings. RESULTS: There were 63,996 patients included. Higher IPAP was associated with increased residual apnea-hypopnea index and mask leak but did not impact device usage per session (average > 6 h/day at all IPAP settings; 6.7 h/day at 95th percentile IPAP 25 cm H2O). There were no clinically relevant differences in respiratory rate, minute ventilation, leak, and residual apnea-hypopnea index across all possible minimum pressure support settings. Patients with a higher 95th percentile IPAP or with minimum pressure support of 3 cm H2O were most likely to remain on ASV therapy at 1 year. CONCLUSIONS: Our findings showed robust levels of longer-term adherence to ASV therapy in a large group of real-world patients. There were no clinically important differences in respiratory parameters across a range of pressure and pressure support settings. Future work should focus on the different phenotypes of patients using ASV therapy. CITATION: Malhotra A, Benjafield AV, Cistulli PA, et al. Characterizing respiratory parameters, settings, and adherence in real-world patients using adaptive servo ventilation therapy: big data analysis. J Clin Sleep Med. 2021;17(12):2355-2362.

Positive Airway Pressure Therapy Adherence with Mask Resupply: A Propensity-Matched Analysis.

There are currently few data on the impact of mask resupply on longer-term adherence to positive airway pressure (PAP) therapy. This retrospective analysis investigated the effects of mask/mask cushion resupply on the adherence to PAP versus no resupply. Deidentified patient billing data for PAP supply items were merged with telemonitoring data from Cloud-connected AirSense 10/AirCurve 10 devices via AirViewTM (ResMed). Eligible patients started PAP between 1 July 2014 and 17 June 2016, had ≥360 days of PAP device data, and achieved initial U.S. Medicare adherence criteria. Patients who received a resupply of mask systems/cushions (resupply group) were propensity-score-matched with those not receiving any mask/cushion resupply (control group). A total of 100,370 patients were included. From days 91 to 360, the mean device usage was 5.6 and 4.5 h/night in the resupply and control groups, respectively (p < 0.0001). The proportion of patients with a mean device usage ≥4 h/night was significantly higher in the resupply group versus the control group (77% vs. 59%; p < 0.0001). The therapy termination rate was significantly lower in the resupply group versus the control group (14.7% vs. 31.9%; p < 0.0001); there was a trend toward lower therapy termination rates as the number of resupplies increased. The replacement of mask interface components was associated with better longer-term adherence to PAP therapy versus no resupply.

Adherence with positive airway pressure therapy for obstructive sleep apnea in developing vs. developed countries: a big data study.

STUDY OBJECTIVES: Minimal focus has been placed on variations in health care delivery for obstructive sleep apnea (OSA). This study compared positive airway pressure usage in developing countries (Brazil and Mexico) vs. a developed country (United States) and investigated the impact of a patient engagement tool (myAir; ResMed, San Diego, CA) on adherence. METHODS: Deidentified data from the AirView database (ResMed) for patients receiving positive airway pressure therapy with wirelessly connected Air10 (AirSense and AirCurve) devices in Brazil, Mexico, and the United States were analyzed. Adherence was defined using US Center for Medicare and Medicaid Services (CMS) criteria (usage ≥ 4 h/night on ≥ 70% of nights in the first 90 days). RESULTS: The analysis included 4,181,490 patients (Brazil: 31,672; Mexico 16,934; United States: 4,132,884). CMS adherence over 90 days was slightly lower in Latin America vs. the United States (Brazil: 71.7%; Mexico: 66.4%; United States: 74.0%). Significantly fewer patients were using the patient engagement tool in Brazil (8.1%) and Mexico (2.8%) vs. the United States (26%; both P < .001). Patients registered to use an engagement tool had a higher rate of CMS adherence and were twice as likely to achieve CMS adherence. Average daily usage and days with usage > 4 hours in the first week were the strongest predictors of CMS adherence. Across all countries, > 80% of patients meeting CMS criteria at 3 months were still using positive airway pressure therapy at 1 year, with 1-year adherences rates of > 75%. CONCLUSIONS: Short-term and long-term positive airway pressure adherence rates in Brazil and Mexico were similar to those achieved in the United States. Patients who registered to use an engagement tool consistently had better adherence than those who did not.

Adherence in children using positive airway pressure therapy: a big-data analysis.

BACKGROUND: Positive airway pressure (PAP) has become a prominent treatment for children with sleep-disordered breathing. However, there are no large-scale studies to clarify whether PAP is well tolerated in children, and which factors are associated with better adherence to PAP therapy. In this study, we aimed to clarify adherence patterns of PAP therapy in a large paediatric population. METHODS: We did a cross-sectional big-data analysis in children from Oct 1, 2014, to Aug 1, 2018, using existing data derived from PAP devices uploaded nightly in the AirView cloud database. The AirView database is a usage tracking system available to all patients who are assigned PAP therapy, which requires consent from the patient or parent or guardian. All patients older than 4 years and younger than 18 years who used continuous or automated PAP devices were evaluated. Only patients living in the USA and enrolled with a single insurance company were included. If patients were participating in an engagement programme, programme onset must have been within 7 days of therapy onset. Our primary outcome was the proportion of patients who used PAP continuously over 90 days. The primary outcome was assessed in all patients who met the age inclusion criterion and had reliable age data available. Data on missing PAP use were imputed as zero, but data on other metrics were not imputed and excluded from analysis. FINDINGS: We used data recorded from Oct 1, 2014, to Aug 1, 2018. Of 40 140 children screened, 36 058 (89·8%) were US residents and 20 553 (90·1%) of them met the eligibility criteria and had accessible data (mean age 13·0 years [SD 3·7]). On the basis of 90 days of monitoring data, 12 699 (61·8%) patients continuously used PAP. Factors significantly associated with adherence included age group, residual apnoea-hypopnoea index, use and onset of patient engagement programmes, PAP pressure, and nightly median PAP mask leak, all over the 90-day study period. INTERPRETATION: To our knowledge, our study represents the largest analysis of children using PAP therapy to date. The findings suggest that adherence to PAP therapy is lower than in previous reports from adults. However, numerous actionable factors were associated with improvements in adherence and should be used strategically in clinical decision making to improve PAP adherence in children. FUNDING: ResMed.

Continuous positive airway pressure versus standard care for the treatment of people with mild obstructive sleep apnoea (MERGE): a multicentre, randomised controlled trial.

BACKGROUND: The evidence base for the treatment of mild obstructive sleep apnoea is limited and definitions of disease severity vary. The MERGE trial investigated the clinical effectiveness of continuous positive airway pressure in patients with mild obstructive sleep apnoea. METHODS: MERGE, a multicentre, parallel, randomised controlled trial enrolled patients (≥18 years to ≤80 years) with mild obstructive sleep apnoea (apnoea-hypopnoea index [AHI] ≥5 to ≤15 events per h using either AASM 2007 or AASM 2012 scoring criteria) from 11 UK sleep centres. Participants were assigned (1:1) to either 3 months of continuous positive airway pressure plus standard care (sleep counselling), or standard care alone, by computer-generated randomisation; neither participants nor researchers were blinded. The primary outcome was a change in the score on the Short Form-36 questionnaire vitality scale in the intention-to-treat population of patients with mild obstructive sleep apnoea diagnosed using the American Academy of Sleep Medicine 2012 scoring criteria. The study is registered with ClinicalTrials.gov, NCT02699463. FINDINGS: Between Nov 28, 2016 and Feb 12, 2019, 301 patients were recruited and randomised. 233 had mild obstructive sleep apnoea using AASM 2012 criteria and were included in the intention-to-treat analysis: 115 were allocated to receive continuous positive airway pressure and 118 to receive standard care. 209 (90%) of these participants completed the trial. The vitality score significantly increased with a treatment effect of a mean of 10·0 points (95% CI 7·2-12·8; p<0·0001) after 3 months of continuous positive airway pressure, compared with standard care alone (9·2 points [6·8 to 11·6] vs -0·8 points [-3·2 to 1·5]). Using the ANCOVA last-observation-carried-forward analysis, a more conservative estimate, the vitality score also significantly increased with a treatment effect of a mean of 7·5 points (95% CI 5·3 to 9·6; p<0·0001) after 3 months of continuous positive airway pressure, compared with standard care alone (7·5 points [6·0 to 9·0] vs 0·0 points [-1·5 to 1·5]). Three serious adverse events occurred (one allocated to the continuous positive airway pressure group) and all were unrelated to the intervention. INTERPRETATION: 3 months of treatment with continuous positive airway pressure improved the quality of life in patients with mild obstructive sleep apnoea. These results highlight the need for health-care professionals and providers to consider treatment for patients with mild obstructive sleep apnoea. FUNDING: ResMed Ltd.