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      Development and validation of a novel non‐contact monitor of nocturnal respiration for identifying sleep‐disordered breathing in patients with heart failure

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          Abstract

          Aims

          At least 50% of patients with heart failure (HF) may have sleep‐disordered breathing (SDB). Overnight in‐hospital polysomnography (PSG) is considered the gold standard for diagnosis, but a lack of access to such testing contributes to under‐diagnosis of SDB. Therefore, there is a need for simple and reliable validated methods to aid diagnosis in patients with HF. The aim of this study was to investigate the accuracy of a non‐contact type IV screening device, SleepMinder TM (SM), compared with in‐hospital PSG for detecting SDB in patients with HF.

          Methods and results

          The study included 75 adult patients with systolic HF and suspected SDB who underwent simultaneous PSG and SM recordings. An algorithm was developed from the SM signals, using digital signal processing and pattern recognition techniques to calculate the SM apnoea‐hypopnoea index (AHI). This was then compared with expert‐scored PSG AHI. The SM algorithm had 70% sensitivity and 89% specificity for identifying patients with clinically significant SDB (AHI ≥ 15/h). At this threshold, it had a positive likelihood ratio of 6.3 and a negative likelihood ratio of 0.16. The overall accuracy of the SM AHI algorithm was 85.8% as shown by the area under a receiver operator characteristic curve. The mean AHI with SM was 3.8/h (95% confidence interval 0.5–7.1) lower than that with PSG.

          Conclusions

          The accuracy of the non‐contact type IV screening device SM is good for clinically significant SDB in patients with systolic HF and could be considered as a simple first step in the diagnostic pathway.

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          Most cited references28

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          Long-term cardiovascular outcomes in men with obstructive sleep apnoea-hypopnoea with or without treatment with continuous positive airway pressure: an observational study.

          The effect of obstructive sleep apnoea-hypopnoea as a cardiovascular risk factor and the potential protective effect of its treatment with continuous positive airway pressure (CPAP) is unclear. We did an observational study to compare incidence of fatal and non-fatal cardiovascular events in simple snorers, patients with untreated obstructive sleep apnoea-hypopnoea, patients treated with CPAP, and healthy men recruited from the general population. We recruited men with obstructive sleep apnoea-hypopnoea or simple snorers from a sleep clinic, and a population-based sample of healthy men, matched for age and body-mass index with the patients with untreated severe obstructive sleep apnoea-hypopnoea. The presence and severity of the disorder was determined with full polysomnography, and the apnoea-hypopnoea index (AHI) was calculated as the average number of apnoeas and hypopnoeas per hour of sleep. Participants were followed-up at least once per year for a mean of 10.1 years (SD 1.6) and CPAP compliance was checked with the built-in meter. Endpoints were fatal cardiovascular events (death from myocardial infarction or stroke) and non-fatal cardiovascular events (non-fatal myocardial infarction, non-fatal stroke, coronary artery bypass surgery, and percutaneous transluminal coronary angiography). 264 healthy men, 377 simple snorers, 403 with untreated mild-moderate obstructive sleep apnoea-hypopnoea, 235 with untreated severe disease, and 372 with the disease and treated with CPAP were included in the analysis. Patients with untreated severe disease had a higher incidence of fatal cardiovascular events (1.06 per 100 person-years) and non-fatal cardiovascular events (2.13 per 100 person-years) than did untreated patients with mild-moderate disease (0.55, p=0.02 and 0.89, p<0.0001), simple snorers (0.34, p=0.0006 and 0.58, p<0.0001), patients treated with CPAP (0.35, p=0.0008 and 0.64, p<0.0001), and healthy participants (0.3, p=0.0012 and 0.45, p<0.0001). Multivariate analysis, adjusted for potential confounders, showed that untreated severe obstructive sleep apnoea-hypopnoea significantly increased the risk of fatal (odds ratio 2.87, 95%CI 1.17-7.51) and non-fatal (3.17, 1.12-7.51) cardiovascular events compared with healthy participants. In men, severe obstructive sleep apnoea-hypopnoea significantly increases the risk of fatal and non-fatal cardiovascular events. CPAP treatment reduces this risk.
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            Estimation of the clinically diagnosed proportion of sleep apnea syndrome in middle-aged men and women.

            The proportion of sleep apnea syndrome (SAS) in the general adult population that goes undiagnosed was estimated from a sample of 4,925 employed adults. Questionnaire data on doctor-diagnosed sleep apnea were followed up to ascertain the prevalence of diagnosed sleep apnea. In-laboratory polysomnography on a subset of 1,090 participants was used to estimate screen-detected sleep apnea. In this population, without obvious barriers to health care for sleep disorders, we estimate that 93% of women and 82% of men with moderate to severe SAS have not been clinically diagnosed. These findings provide a baseline for assessing health care resource needs for sleep apnea.
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              Association of nocturnal arrhythmias with sleep-disordered breathing: The Sleep Heart Health Study.

              Sleep-disordered breathing recurrent intermittent hypoxia and sympathetic nervous system activity surges provide the milieu for cardiac arrhythmia development. We postulate that the prevalence of nocturnal cardiac arrhythmias is higher among subjects with than without sleep-disordered breathing. The prevalence of arrhythmias was compared in two samples of participants from the Sleep Heart Health Study frequency-matched on age, sex, race/ethnicity, and body mass index: (1) 228 subjects with sleep-disordered breathing (respiratory disturbance index>or=30) and (2) 338 subjects without sleep-disordered breathing (respiratory disturbance index<5). Atrial fibrillation, nonsustained ventricular tachycardia, and complex ventricular ectopy (nonsustained ventricular tachycardia or bigeminy or trigeminy or quadrigeminy) were more common in subjects with sleep-disordered breathing compared with those without sleep-disordered breathing: 4.8 versus 0.9% (p=0.003) for atrial fibrillation; 5.3 versus 1.2% (p=0.004) for nonsustained ventricular tachycardia; 25.0 versus 14.5% (p=0.002) for complex ventricular ectopy. Compared with those without sleep-disordered breathing and adjusting for age, sex, body mass index, and prevalent coronary heart disease, individuals with sleep-disordered breathing had four times the odds of atrial fibrillation (odds ratio [OR], 4.02; 95% confidence interval [CI], 1.03-15.74), three times the odds of nonsustained ventricular tachycardia (OR, 3.40; 95% CI, 1.03-11.20), and almost twice the odds of complex ventricular ectopy (OR, 1.74; 95% CI, 1.11-2.74). A significant relation was also observed between sleep-disordered breathing and ventricular ectopic beats/h (p<0.0003) considered as a continuous outcome. Individuals with severe sleep-disordered breathing have two- to fourfold higher odds of complex arrhythmias than those without sleep-disordered breathing even after adjustment for potential confounders.
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                Author and article information

                Journal
                ESC Heart Fail
                ESC Heart Fail
                10.1002/(ISSN)2055-5822
                EHF2
                ESC Heart Failure
                John Wiley and Sons Inc. (Hoboken )
                2055-5822
                01 March 2016
                September 2016
                : 3
                : 3 ( doiID: 10.1002/ehf2.v3.3 )
                : 212-219
                Affiliations
                [ 1 ] National Institute for Health Research Cardiovascular and Respiratory Biomedical Research Units Royal Brompton Hospital London UK
                [ 2 ] Imperial College London London UK
                [ 3 ] ResMed Ltd. Sydney Australia
                [ 4 ] ResMed Sensor Technologies Dublin Ireland
                [ 5 ] Graduate School of Biomedical Engineering University of New South Wales Sydney Australia
                [ 6 ] Department of Pneumology, Ruhrlandklinik, West German Lung Center University Hospital Essen, University Duisburg‐Essen Essen Germany
                [ 7 ] Clinic of Pneumology, Allergology, Sleep and Respiratory Medicine Diakonie Kaiserswerth Düsseldorf Germany
                [ 8 ] Thorax Center Ruhrgebiet, Clinic of Pneumology and Infectiology Evangelisches Krankenhaus Herne und Augusta‐Kranken‐Anstalt Bochum Germany
                Author notes
                [*] [* ]Correspondence to: Rami N. Khushaba, Applied Research, ResMed Ltd, Sydney, Australia, Tel: +61 2 8884 1897, Fax: +61 2 8884 2008. Email: Rami.Khushaba@ 123456resmed.com.au
                Article
                EHF212086 ESCHF-2015-07-0056.R2
                10.1002/ehf2.12086
                5747002
                28834663
                50898268-b159-48e8-a8b4-47c914268be6
                © 2016 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of the European Society of Cardiology.

                This is an open access article under the terms of the Creative Commons Attribution‐NonCommercial‐NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made.

                History
                : 06 August 2015
                : 10 January 2016
                : 24 January 2016
                Page count
                Pages: 8
                Categories
                Original Research Article
                Original Research Articles
                Custom metadata
                2.0
                ehf212086
                ehf212086-hdr-0001
                September 2016
                Converter:WILEY_ML3GV2_TO_NLMPMC version:5.2.8 mode:remove_FC converted:29.12.2017

                heart failure,sleep‐disordered breathing,apnoea‐hypopnoea index,diagnosis

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