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.

Initiation of therapy for obstructive sleep apnea syndrome: a randomized comparison of outcomes of telemetry-supported home-based vs. sleep lab-based therapy initiation.

PURPOSE: Diagnosis and treatment of obstructive sleep apnea are traditionally performed in sleep laboratories with polysomnography (PSG) and are associated with significant waiting times for patients and high cost. We investigated if initiation of auto-titrating CPAP (APAP) treatment at home in patients with obstructive sleep apnea (OSA) and subsequent telemonitoring by a homecare provider would be non-inferior to in-lab management with diagnostic PSG, subsequent in-lab APAP initiation, and standard follow-up regarding compliance and disease-specific quality of life. METHODS: This randomized, open-label, single-center study was conducted in Germany. Screening occurred between December 2013 and November 2015. Eligible patients with moderate-to-severe OSA documented by polygraphy (PG) were randomized to home management or standard care. All patients were managed by certified sleep physicians. The home management group received APAP therapy at home, followed by telemonitoring. The control group received a diagnostic PSG, followed by therapy initiation in the sleep laboratory. The primary endpoint was therapy compliance, measured as average APAP usage after 6 months. RESULTS: The intention-to-treat population (ITT) included 224 patients (110 home therapy, 114 controls); the per-protocol population (PP) included 182 patients with 6-month device usage data (89 home therapy, 93 controls). In the PP analysis, mean APAP usage at 6 months was not different in the home therapy and control groups (4.38 ± 2.04 vs. 4.32 ± 2.28, p = 0.845). The pre-specified non-inferiority margin (NIM) of 0.3 h/day was not achieved (p = 0.130); statistical significance was achieved in a post hoc analysis when NIM was set at 0.5 h/day (p < 0.05). Time to APAP initiation was significantly shorter in the home therapy group (7.6 ± 7.2 vs. 46.1 ± 23.8 days; p < 0.0001). CONCLUSION: Use of a home-based telemonitoring strategy for initiation of APAP in selected patients with OSA managed by sleep physicians is feasible, appears to be non-inferior to standard sleep laboratory procedures, and facilitates faster access to therapy.

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.

Unrecognized pulmonary arterial hypertension in hospitalized patients.

Pulmonary hypertension (PH) is an underdiagnosed and potentially fatal condition. The utility of screening for PH in hospitalized patients undergoing echocardiography is unknown. The goal of this study was to determine the prevalence of undiagnosed pulmonary hypertension (PH) and probable pulmonary arterial hypertension (PAH) in hospitalized patients undergoing echocardiography for any indication. All hospitalized patients undergoing echocardiography were identified and echocardiographs reviewed prospectively for the presence of a tricuspid regurgitant (TR) jet. Electronic medical records (EMR) of patients with a TR jet ≥ 3 m/s were reviewed for identifiable causes of pulmonary hypertension. Patients with no identifiable cause were classified as presumptive World Health Organization (WHO) Group 1 PH (also known as PAH). These PAH patients were compared to other PH patients for baseline demographic characteristics and comorbidities as well as 30-day readmission and mortality. The admitting physicians of patients classified as PH were advised to consider further evaluation including right heart catheterization. We reviewed 4417 consecutive echocardiograms and identified 448 with a TR jet ≥ 3 m/s. Of these 448 patients with PH, 47 were identified as "presumptive PAH" and the other 401 as having PH belonging to WHO Groups 2-5. Presumptive PAH represented 1% of screened echocardiograms and 10.5% of those identified to have an elevated TR jet. Of the patients identified as presumptive PAH, 8 underwent further evaluation including a right heart catheterization, where 5 were confirmed to have PAH. Kaplan-Meier analysis revealed 30-day readmission was higher among those classified as PAH. Our data shows that pulmonary hypertension, as defined by TR jet ≥ 3 m/s, is frequently encountered in hospitalized patients undergoing echocardiography for any reason. A careful review of echocardiogram findings and clinical history suggested 10.5% of those with PH (and 1% of all screened patients) may meet the criteria for PAH. Considering PH is a fatal condition which is frequently missed, a hospital screening program seems feasible.

Sleep Disordered Breathing in Hospitalized African-Americans.

RATIONALE: Sleep-disordered breathing (SDB) is a common disorder in general population, with higher prevalence in population with comorbid cardiovascular disease, and yet it remains frequently undiagnosed. Prior published data show that hospitalized obese patients have a high incidence of unrecognized SDB. However, limited data exists on the incidence, prevalence, and impact of SDB in hospitalized obese African-American (AA) patients. This study was performed to better understand the burden of undiagnosed SDB in hospitalized AA patients and its implications on readmission. METHODS: A total of 1243 consecutive obese AA patients admitted to medical or telemetry service were screened utilizing a screening questionnaire (STOP/STOPBANG) from October 2016 to October 2017. If the results of the screening questionnaire were positive, the patients were offered inpatient testing with either High Resolution Pulse Oximetry (HRPO), or a type 3 portable monitor (PM). SDB was suspected if the Oxygen Desaturation Index (ODI) or Apnea Hypopnea Index (AHI) ≥ 5. We collected 30-day readmission and emergency department (ED) visit data on all patients and requested a formal outpatient sleep study for patients identified as SDB positive. RESULTS: Of the 1243 AA patients screened, 852 (68.5%) patients screened positive for SDB. Of these high-risk screens, 538 (63.1%) patients underwent inpatient testing with either High Resolution Pulse Oximetry (HRPO) or PM. Of these 538 patients, 319 (59.3%) were found to have suspected obstructive sleep apnea (OSA) based on ODI/AHI >5. Mild SDB (AHI 5-14) was present in 149 (46.7%) patients; moderate (AHI 15-29) in 74 (23.2%) patients; and severe (AHI >30) in 96 (30.1%) patients. The patients with suspected SDB were educated and encouraged to get an out-patient polysomnogram (PSG) but only 32 (10.0%) returned to undergo a formal PSG. The 30-day readmission rate/ED visits for patient with SDB was 13.5% compared to 13.7% of patients without SDB. CONCLUSION: This is the largest SDB registry that included obese hospitalized AA patients in a tertiary care academic center and reveals a high prevalence of undiagnosed SDB in this cohort. Despite proactive screening and patient education only 3.8% (32/852) of patients returned post-discharge for formal polysomnography. The presence of SDB did not impact the 30-day readmission rate/ED visit rate in this cohort.

Undiagnosed OSA May Significantly Affect Outcomes in Adults Admitted for COPD in an Inner-City Hospital.

BACKGROUND: COPD is the second most common cause of hospital admission in the United States. OSA is a highly prevalent and underdiagnosed condition that may affect the outcome of COPD. RESEARCH QUESTION: We hypothesized that presence of unrecognized and untreated OSA will increase hospital readmissions in patients admitted for COPD exacerbation. STUDY DESIGN AND METHODS: We reviewed patients admitted for COPD exacerbation from May 2017 through July 2018 who were also screened for previously unrecognized and untreated OSA with a sleep questionnaire, and who subsequently underwent a high-resolution pulse oximetry or portable sleep monitoring study. We compared the rates of 30-, 90-, and 180-day readmission or death across OSA categories and compared overall survival in patients with and without OSA. RESULTS: Of 380 patients admitted for COPD exacerbation, 256 were screened for OSA with a sleep questionnaire (snoring, tiredness during daytime, observed apnea, high BP). Of these, 238 underwent an overnight high-resolution pulse oximetry/portable sleep monitoring. Of the 238 total patients, 111 (46.6%) were found to have OSA; 28.6% had mild, 9.7% moderate, and 8.4% severe OSA. Baseline characteristics and demographics were compared between the cohorts of participants with OSA and without OSA and were similar except that patients with OSA had a higher mean BMI (33.9 vs 30.3 kg/m2) and an increased prevalence of heart failure (19.8% vs 7.1%). For patients with COPD and mild OSA, odds of 30-day readmission were 2.05 times higher than for patients without OSA (32.4% vs 18.9%). Additionally, odds of 30-day readmission were 6.68 times higher for patients with moderate OSA vs patients without OSA (60.9% vs 18.9%) and 10.01 times high for patients with severe OSA vs patients without OSA (70% vs 18.9%). Readmission rates were also greater at 90 and 180 days. All-cause mortality was lower for patients without OSA than for patients with OSA (P < .01). The time to hospital readmission or death was shorter with greater OSA severity (P < .01). INTERPRETATION: Patients hospitalized for COPD exacerbation and who have unrecognized OSA; 30-, 90-, and 180-day readmission rates; and 6-month mortality rates are higher than in those without OSA.

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.

Opiate Use and Escalation of Care in Hospitalized Adults with Acute Heart Failure and Sleep-disordered Breathing (OpiatesHF Study).

Rationale: Sleep-disordered breathing (SDB) is highly prevalent in adults hospitalized with acute heart failure. Data are limited on the implications of inadvertent opiate use in this population.Objectives: To determine the prevalence and impact of in-hospital opiate use in adults hospitalized for acute heart failure.Methods: From a prospective sleep registry, we selected a sequential group of adult participants who were admitted to the hospital for acute heart failure and received a portable sleep study (PSS) after screening for SDB using the STOP-BANG questionnaire. A retrospective review of charts was performed to assess use of opiates, need for escalation of care (defined as transfer to the intensive care unit [ICU]), 30-day readmission, and length of stay. A logistic regression model was used to calculate propensity scores for each participant with a screening apnea-hypopnea index (AHI) greater than or equal to 10/h. Study endpoints, including escalation of care to the ICU and 30-day hospital readmission, were compared using a χ2 test with stabilized inverse probability-weighted propensity scores to control for potential confounding variables.Results: A total of 301 consecutive adults admitted with acute heart failure between November 2016 and October 2017 underwent PSS after SDB screening. Overall, 125 of 301 (41.5%) received opiates in the hospital, and 149 (49.5%) patients had an AHI greater than or equal to 10/h by PSS (high risk of SDB). In this high-risk group, 47 of 149 (32%) received opiates. Among those with an AHI greater than or equal to 10/h, escalation of care occurred in 12 of 47 (26%) of those who received opiates versus 4 of 102 (4%) of those who did not (P < 0.001; weighted estimate of treatment difference, 23.5%; 95% confidence interval [CI], 9.9 to 37.2). Similarly, readmission within 30 days occurred in 7 of 47 (15%) of those who received opiates versus 9 of 102 (9%) of those who did not (P = 0.14; weighted estimate of treatment difference, 8.3%; 95% CI, -4.0 to 20.6). Mean length of stay (days) did not differ between groups (P = 0.61; weighted estimate of treatment difference, -0.3 d; 95% CI, -1.4 to 0.8).Conclusions: In adults admitted with acute heart failure and found to be at high risk of SDB, opiate use in the hospital was highly prevalent and was associated with a greater likelihood of escalation of care.

Automatic EPAP intelligent volume-assured pressure support is effective in patients with chronic respiratory failure: A randomized trial.

BACKGROUND AND OBJECTIVE: Patients with chronic respiratory failure are increasingly managed with domiciliary non-invasive ventilation (NIV). There may be limited ability to provide NIV titration for these complex patients, and ventilatory requirements and upper airway support needs may change over time. Therefore, an automatically adjusting expiratory positive airway pressure (AutoEPAP) algorithm may offer advantages over manually adjusted EPAP for treating these patients. This study compared 4% oxygen desaturation index (ODI4%) values during the use of an AutoEPAP algorithm versus manual EPAP titration with the intelligent volume-assured pressure support (iVAPS) algorithm. METHODS: This prospective, single-blind, randomized, crossover study was conducted at six US sites. Patients with chronic respiratory failure (neuromuscular disease, chronic obstructive pulmonary disease, obesity hypoventilation and other aetiologies) and an apnoea-hypopnoea index of >5/h who were already established NIV users underwent a single night of NIV with the iVAPS manual EPAP and iVAPS AutoEPAP in the sleep laboratory in random order. RESULTS: A total of 38 patients constituted the study population. Mean ODI4% was statistically non-inferior with AutoEPAP versus manual EPAP (P < 0.0001). There was no difference in the effect on ODI4% across respiratory failure subgroups. Ventilation parameters and gas exchange were similar with either NIV mode, indicating equally effective treatment of respiratory failure. Sleep parameters were improved during AutoEPAP versus manual EPAP. CONCLUSION: A single night of NIV using the iVAPS with AutoEPAP algorithm was non-inferior to a single night of iVAPS with manual EPAP titration in patients with respiratory failure. CLINICAL TRIAL REGISTRATION: NCT02683772 at clinicaltrials.gov.

Auto positive airway pressure therapy reduces pulmonary pressures in adults admitted for acute heart failure with pulmonary hypertension and obstructive sleep apnea. The ASAP-HF Pilot Trial.

OBJECTIVES: Pulmonary hypertension (PH) is extremely common in acute decompensated heart failure (ADHF) patients and predicts increased mortality. Obstructive sleep apnea (OSA), highly prevalent in congestive heart failure patients, may contribute to further elevated pulmonary pressures. This study evaluates the impact of positive airway pressure (PAP) therapy on PH in patients admitted for ADHF with OSA. METHODS: A two-center randomized control trial comparing standard of care (SOC) therapy for ADHF versus addition of PAP therapy in patients with concomitant OSA. RESULTS: Twenty-one consecutive patients were enrolled with 1:1 randomization to SOC versus SOC plus 48-hour PAP therapy protocol. In the intervention arm, the mean pulmonary artery systolic pressure (PASP) difference before therapy and after 48 hours of PAP therapy was -15.8 ± 3.2 (58.6 ± 2.5 mm Hg to 42.8 ± 2.7) versus the SOC arm where the mean PASP difference was -5.2 ± 2.6 (62.7 ± 3.3 mm Hg reduced to 57.5 ± 3.9) (p = 0.025). In addition, ejection fraction in the intervention arm improved (3.4 ± 1.5% versus -0.5 ± 0.5 %) (p = 0.01). Significant improvement was also noted in tricuspid annular plane systolic excursion (TAPSE) and right ventricular systolic area in the intervention arm but not in NT-pro-BNP or 6-minute walk distance. CONCLUSIONS: In patients with ADHF and OSA, addition of 48 hours of PAP therapy to SOC treatment significantly reduced PH. In addition, PAP therapy was able to improve right and left ventricular function. ClinicalTrials.gov identifier: NCT02963597.

Patient Engagement Using New Technology to Improve Adherence to Positive Airway Pressure Therapy: A Retrospective Analysis.

BACKGROUND: Sleep apnea has major neurocognitive and cardiovascular and metabolic risks. Treatment of sleep apnea is suboptimal because of variable adherence to existing therapies. METHODS: This trial compared positive airway pressure adherence among patients who were provided active patient engagement (APE) technology vs those who received usual care monitoring (UCM). The primary outcome was expressed by using the US Medicare definition of adherence. Adherence data from two cloud-based databases (AirView and myAir) were analyzed for patients with sleep apnea. Data were included if a patient's activation date in the APE tool was within 7 days of the therapy start date in the UCM database during a defined time window. Data were propensity matched in a 1:2 ratio (APE:UCM) based on baseline patient characteristics. RESULTS: A total of 128,037 patients were analyzed. Baseline characteristics were typical of a sleep clinic cohort. APE was associated with more patients achieving adherence criteria (87.3%) compared with UCM patients (70.4%; P < .0001 for the difference). Average therapy usage was 5.9 h per night in the APE group vs 4.9 h per night in the matched UCM patients (P < .0001). Patients with sleep apnea "struggling" with therapy adherence had a 17.6% absolute improvement in adherence using APE compared with UCM. CONCLUSIONS: Robust therapy adherence rates can be achieved by adding modern technology to usual care. Adopting advances in technology in care management may allow clinicians to more effectively and efficiently treat patients who have sleep apnea. Rigorous randomized controlled trials may be required before making strong clinical recommendations.

Sleep Overnight Monitoring for Apnea in Patients Hospitalized with Heart Failure (SOMA-HF Study).

INTRODUCTION: Sleep-disordered breathing (SDB) is highly prevalent in hospitalized patients with congestive heart failure (CHF) and the condition is diagnosed and treated in only a minority of these patients. Portable monitoring (PM) is a screening option, but due to costs and the expertise required, many hospitals may find it impractical to implement. We sought to test the utility of an alternative approach for screening hospitalized CHF patients for SDB, high-resolution pulse oximetry (HRPO). METHODS: We conducted a prospective controlled trial of 125 consecutive patients admitted to the hospital with CHF. Simultaneous PM and HRPO for a single night was performed. All but one patient were monitored on breathing room air. The HRPO-derived ODI (oxygen desaturation index) was compared with PM-derived respiratory event index (REI) using both receiver operator characteristic (ROC) curve analysis and a Bland-Altman plot. RESULTS: Of 105 consecutive CHF patients with analyzable data, 61 (58%) were males with mean age of 64.9 ± 15.1 years and mean body mass index of 30.3 ± 8.3 kg/m2. Of the 105 patients, 10 (9.5%) had predominantly central sleep apnea (central events > 50% of the total events), although central events were noted in 42 (40%) of the patients. The ROC analysis showed an area under the curve of 0.89 for REI > 5 events/h. The Bland-Altman plot showed acceptable agreement with 95% limits of agreement between -28.5 to 33.7 events/h and little bias. CONCLUSIONS: We conclude that high-resolution pulse oximetry is a simple and cost-effective screening tool for SDB in CHF patients admitted to the hospital. Such screening approaches may be valuable for large-scale implementation and for the optimal design of interventional trials.

Adherence to Positive Airway Pressure Therapy in Hospitalized Patients with Decompensated Heart Failure and Sleep-Disordered Breathing.

STUDY OBJECTIVES: Sleep-disordered breathing (SDB) has been implicated as a risk factor for the development of several adverse cardiovascular outcomes, but can be mitigated with positive airway pressure therapy (PAP). The nonadherence of patients with SDB on PAP in the outpatient setting ranges from 29% to 84%. However, adherence of PAP in patients with congestive heart failure (CHF) admitted for decompensated CHF and in whom SDB has been diagnosed in the hospital setting is not known. We hypothesized that despite a diagnosis in the hospital, the compliance of these patients with PAP therapy would not be different from the well-established adherence in patients with a diagnosis and treatment in the outpatient setting. METHODS: The study was a retrospective analysis of patients admitted to an academic tertiary care hospital between March 2013 and February 2014. Patients presenting with decompensated CHF were screened and high-risk patients were started on PAP empirically and advised to undergo a postdischarge polysomnogram. Compliance of the patients with PAP was tracked for over 12 mo. Data from a similar outpatient group who underwent polysomnography during the study period were also reviewed. RESULTS: Ninety-one patients underwent polysomnograhy postdischarge. Of the 91 patients, 81 patients agreed to PAP therapy. One patient was excluded as data were missing. The adherence at 3, 6, and 12 mo was 52%, 37%, and 27%, which was not significantly different than an outpatient control group. There was a trend for those with CHF plus SDB and compliant with PAP to have a higher probability of survival compared to those who were noncompliant (p = 0.07). CONCLUSIONS: Adherence of patients to PAP therapy in whom a SDB diagnosis is made during acute hospitalization for heart failure is comparable to patients in the ambulatory setting. Adherence in first 3 mo is a predictive marker for improved survival trend.

Hospitalized Patients at High Risk for Obstructive Sleep Apnea Have More Rapid Response System Events and Intervention Is Associated with Reduced Events.

BACKGROUND: Rapid response system (RRS) is a safety tool designed for early detection and intervention of a deteriorating patient on the general floor in the hospital. Obstructive sleep apnea (OSA) has been associated with significant cardiovascular complications. We hypothesized that patients with high-risk of OSA have higher rate of RRS events and intervention with positive airway pressure therapy in these patients can mitigate the RRS events. METHODS: As part of a clinical pathway, during a 15 month period, patients with BMI ≥ 30 kg/m2 in select medical services were screened with a validated sleep questionnaire. Patients were characterized as high or low risk based on the screening questionnaire. RRS rates were compared between the groups. Subsequently the impact of PAP therapy on RRS events was evaluated. RESULTS: Out of the 2,590 patients screened, 1,973 (76%) were identified as high-risk. RRS rates calculated per 1,000 admissions, were 43.60 in the High-Risk OSA group versus 25.91 in the Low-Risk OSA Group. The PAP therapy compliant group had significantly reduced RRS event rates compared to non-compliant group and group with no PAP therapy (16.99 vs. 53.40 vs. 56.21) (p < 0.01). CONCLUSION: In a large cohort of patients at a tertiary care hospital, we show an association of increased rate of RRS events in high-risk OSA patients and reduction of the risk with PAP intervention in the compliant group.

The Effect of Treatment of Obstructive Sleep Apnea on Glycemic Control in Type 2 Diabetes.

RATIONALE: There is uncertainty about the effects of treating obstructive sleep apnea on glycemic control in patients with type 2 diabetes. OBJECTIVES: To determine whether treatment of obstructive sleep apnea in patients with type 2 diabetes improves glycemic control. METHODS: In this trial, we randomized patients with type 2 diabetes and no previous diagnosis of obstructive sleep apnea, with a glycated hemoglobin level of 6.5-8.5%, and an oxygen desaturation index of 15 or more events per hour to positive airway pressure therapy or to usual care. MEASUREMENTS AND MAIN RESULTS: A total of 416 patients met the entry criteria as determined by each site and were randomized. Of the 298 participants who met centrally adjudicated entry criteria, no differences between the study groups were seen for change in glycated hemoglobin. Furthermore, there were no between-group differences when analyses were restricted to those with poorer baseline glycemic control, those with more severe sleep apnea, or those who were adherent to therapy. A greater fall in diastolic blood pressure occurred in the positive airway pressure group than in the usual care group (-3.5 mm Hg vs. -1.5 mm Hg; P = 0.07). This difference was significant in those who were adherent to positive airway pressure therapy (-4.4 mm Hg vs. -1.6 mm Hg; P = 0.02). There was a significant reduction in sleepiness in the positive airway pressure therapy group (P < 0.0001). Quality of life assessment revealed improvements in vitality, mental health, and mental component summary scores in the positive airway pressure therapy group. CONCLUSIONS: This trial showed no effect of positive airway pressure therapy on glycemic control in patients with relatively well-controlled type 2 diabetes and obstructive sleep apnea. Clinical trial registered with www.clinicaltrials.gov (NCT00509223).

Effect of Early Intervention With Positive Airway Pressure Therapy for Sleep Disordered Breathing on Six-Month Readmission Rates in Hospitalized Patients With Heart Failure.

Rehospitalization for congestive heart failure (CHF) is high within 6 months of discharge. Sleep disordered breathing (SDB) is common and underdiagnosed condition in patients with CHF. We hypothesized that early recognition and treatment of SDB in hospitalized patients with CHF will reduce hospital readmissions and emergency room visits. Patients admitted for CHF underwent overnight polysomnography within 4 weeks of discharge. Patients diagnosed with SDB were provided therapy with positive airway pressure therapy. Patients were identified as having good compliance if the device use was for a minimum of 4 hours 70% of the time for a minimum of 4 weeks during the first 3 months of therapy. Hospital admissions for 6 months before therapy were compared with readmission within 6 months after therapy in patients with good and poor compliance. A total of 70 patients were diagnosed with SDB after discharge. Of the 70 patients, 37 (53%) were compliant with positive airway pressure therapy. Compliant patients were more likely to be older (64 ± 12 vs 58 ± 11 years) and women (54% vs 33%) and less likely to be patient with diabetes (40% vs 67%) versus noncompliant patients. Although both groups experienced a decrease in total readmissions, compliant patients had a significant reduction (mean ± SE: -1.5 ± 0.2 clinical events vs -0.2 ± 0.3; p <0.0001). In this single-center analysis, identification and treatment of SDB in admitted patients with CHF with SDB is associated with reduced readmissions over 6 months after discharge. Adherence to the treatment was associated with a greater reduction in clinical events.

A telehealth program for CPAP adherence reduces labor and yields similar adherence and efficacy when compared to standard of care.

PURPOSE: This study evaluated the effectiveness and coaching labor requirements of a web-based automated telehealth (TH) messaging program compared with standard of care (SOC) in newly diagnosed patients with obstructive sleep apnea (OSA). METHODS: In this non-blinded, multicenter, prospective study, all patients were started on continuous positive airway pressure (CPAP) with heated humidification and a wireless modem. They all received standardized CPAP education and setup. Patients in the TH group (n = 58) received an automated series of text messages and/or e-mails that were triggered by preset conditions. Patients in the SOC group (n = 64) received scheduled calls on days 1, 7, 14, and 30. Additional contacts were allowed for patients in both groups as deemed clinically necessary. Coaching labor was calculated by totaling the number and type of patient contacts and assigning historical time values. RESULTS: One hundred twenty-two patients were included in the final analysis. There were no statistically significant differences between the TH and SOC groups for Medicare adherence (83 vs. 73 %), daily CPAP usage (5.1 ± 1.9 h vs. 4.7 ± 2.1 h), CPAP efficacy (mean residual apnea-hypopnea index (3.0 ± 4.1/h vs. 2.8 ± 3.8/h), or change in Epworth Sleepiness Scale score (-5.8 ± 5.5 vs. -5.1 ± 5.9), although all trends favored the TH group. There was, however, a significant reduction in the number of minutes coaching required per patient in the TH vs. SOC group (23.9 ± 26 vs. 58.3 ± 25, 59 % reduction; p < 0.0001). CONCLUSIONS: Use of a web-based telehealth program for CPAP adherence coaching significantly reduced the coaching labor requirement compared with SOC, while maintaining similar adherence and effectiveness.

Early recognition of obstructive sleep apnea in patients hospitalized with COPD exacerbation is associated with reduced readmission.

OBJECTIVES: The combination of obstructive sleep apnea (OSA) and chronic obstructive pulmonary disease is known as the "overlap syndrome", and results in frequent hospitalizations and worse prognosis. We hypothesized that early detection and treatment of this condition in hospitalized patients may reduce clinical events (hospital admissions and emergency room visits) Methods: Between April 2013 and January 2014 all patients consulted for COPD exacerbation and having a BMI of > 30 kg/m(2) were screened for OSA. If high risk, patients underwent a polysomnography on discharge. Readmission rate in patients compliant with positive airway pressure was compared to patients who were deemed non-compliant based on objective data from the device. RESULTS: Full polysomnogram data and compliance was available on 24 patients. The baseline characteristics were comparable between the compliant and non-compliant groups. The mean change in the total clinical events 6 months prior to intervention compared to 6 months following intervention was -2.1 ± 0.3 in the compliant group, compared to -0.8 ± 0.5 in the non-compliant group (p = 0.01). The mean change in the total clinical events 12 months prior to intervention compared to 12 months following intervention was -2.7 ± 0.5 in the compliant group, compared to -0.8 ± 0.6 in the non-compliant group (p = 0.03) CONCLUSION: In conclusion, our data suggest that early recognition and treatment of OSA in patients admitted with COPD exacerbation and compliant with PAP therapy is associated with reduced 6-month hospital readmission rates and emergency room visits. Screening for OSA in patients admitted with COPD exacerbation is a simple and early intervention that should be encouraged to help reduce hospital readmissions in this patient population.

Evaluation of a new pediatric positive airway pressure mask.

STUDY OBJECTIVES: The choice and variety of pediatric masks for continuous positive airway pressure (CPAP) is limited in the US. Therefore, clinicians often prescribe modified adult masks. Until recently a mask for children aged < 7 years was not available. This study evaluated apnea-hypopnea index (AHI) equivalence and acceptability of a new pediatric CPAP mask for children aged 2-7 years (Pixi; ResMed Ltd, Sydney, Australia). METHODS: Patients aged 2-7 years were enrolled and underwent in-lab baseline polysomnography (PSG) using their previous mask, then used their previous mask and the VPAP III ST-A flow generator for ≥ 10 nights at home. Thereafter, patients switched to the Pixi mask for ≥ 2 nights before returning for a PSG during PAP therapy via the Pixi mask. Patients then used the Pixi mask at home for ≥ 21 nights. Patients and their parents/guardians returned to the clinic for follow-up and provided feedback on the Pixi mask versus their previous mask. RESULTS: AHI with the Pixi mask was 1.1 ± 1.5/h vs 2.6 ± 5.4/h with the previous mask (p = 0.3538). Parents rated the Pixi mask positively for: restfulness of the child's sleep, trouble in getting the child to sleep, and trouble in having the child stay asleep. The Pixi mask was also rated highly for leaving fewer or no marks on the upper lip and under the child's ears, and being easy to remove. CONCLUSIONS: The Pixi mask is suitable for children aged 2-7 years and provides an alternative to other masks available for PAP therapy in this age group.

A novel adaptive servoventilation (ASVAuto) for the treatment of central sleep apnea associated with chronic use of opioids.

STUDY OBJECTIVES: To compare the efficacy and patient comfort of a new mode of minute ventilation-targeted adaptive servoventilation (ASVAuto) with auto-titrating expiratory positive airway pressure (EPAP) versus bilevel with back-up respiratory rate (bilevel-ST) in patients with central sleep apnea (CSA) associated with chronic use of opioid medications. METHODS: Prospective, randomized, crossover polysomnography (PSG) study. Eighteen consecutive patients (age ≥ 18 years) who had been receiving opioid therapy (≥ 6 months), and had sleep disordered breathing with CSA (central apnea index [CAI] ≥ 5) diagnosed during an overnight sleep study or positive airway pressure (PAP) titration were enrolled to undergo 2 PSG studies-one with ASVAuto and one with bilevel-ST. Patients completed 2 questionnaires after each PSG; Morning After Patient Satisfaction Questionnaire and PAP Comfort Questionnaire. RESULTS: Patients had a mean age of 52.9 ± 15.3 years. PSG prior to randomization showed an apnea hypopnea index (AHI) of 50.3 ± 22.2 and CAI of 13.0 ± 18.7. Titration with ASVAuto versus bilevel-ST showed that there were significant differences with respect to AHI and CAI. The AHI and CAI were significantly lower on ASVAuto than bilevel-ST (2.5 ± 3.5 versus 16.3 ± 20.9 [p = 0.0005], and 0.4 ± 0.8 versus 9.4 ± 18.8 [p = 0.0002], respectively). Respiratory parameters were normalized in 83.3% of patients on ASVAuto versus 33.3% on bilevel-ST. Patients felt more awake and alert on ASVAuto than bilevel-ST based on scores from Morning After Patient Satisfaction Questionnaire (p = 0.0337). CONCLUSIONS: The ASVAuto was significantly more effective than bilevel-ST for the treatment of CSA associated with chronic opioid use.