Validation of the Sleepiz One + as a radar-based sensor for contactless diagnosis of sleep apnea.

PURPOSE: The cardiorespiratory polysomnography (PSG) is an expensive and limited resource. The Sleepiz One + is a novel radar-based contactless monitoring device that can be used e.g. for longitudinal detection of nocturnal respiratory events. The present study aimed to compare the performance of the Sleepiz One + device to the PSG regarding the accuracy of apnea-hypopnea index (AHI). METHODS: From January to December 2021, a total of 141 adult volunteers who were either suspected of having sleep apnea or who were healthy sleepers took part in a sleep study. This examination served to validate the Sleepiz One + device in the presence and absence of additional SpO2 information. The AHI determined by the Sleepiz One + monitor was estimated automatically and compared with the AHI derived from manual PSG scoring. RESULTS: The correlation between the Sleepiz-AHI and the PSG-AHI with and without additional SpO2 measurement was rp = 0.94 and rp = 0,87, respectively. In general, the Bland-Altman plots showed good agreement between the two methods of AHI measurement, though their deviations became larger with increasing sleep-disordered breathing. Sensitivity and specificity for recordings without additional SpO2 was 85% and 88%, respectively. Adding a SpO2 sensor increased the sensitivity to 88% and the specificity to 98%. CONCLUSION: The Sleepiz One + device is a valid diagnostic tool for patients with moderate to severe OSA. It can also be easily used in the home environment and is therefore beneficial for e.g. immobile and infectious patients. TRIAL REGISTRATION NUMBER AND DATE OF REGISTRATION FOR PROSPECTIVELY REGISTERED TRIALS: This study was registered on clinicaltrials.gov (NCT04670848) on 2020-12-09.

Positive airway pressure telehealth models and long-term therapy termination: a healthcare database analysis.

Background: Telemonitoring-guided interventions can improve short-term positive airway pressure (PAP) therapy adherence, but long-term effects are unknown. This study investigated long-term PAP therapy termination in patients with sleep apnoea managed with standard care, telemonitoring-guided proactive care or telemonitoring-guided proactive care + patient engagement tool. Methods: German healthcare provider data were analysed retrospectively. Individuals aged 18-100 years who started PAP from 2014 to 2019 and had device type/interface data were included. Time-to-termination periods were analysed using Kaplan-Meier plots and Cox proportional hazards regression, adjusted for age, sex, insurance type, and device and mask type. Results: The per-protocol population (valid telemonitoring data) included 104 612 individuals (71% male; 95% aged >40 years). Mean follow-up was 3.3±2.0 years. The overall therapy termination rate was significantly lower in the telemonitoring-guided proactive care group versus standard care (20% versus 27%; p<0.001), and even lower in the telemonitoring-guided care + patient engagement tool group (11%; p<0.001 versus other treatment groups). Adjusted risk of therapy termination was lower versus standard care (hazard ratio 0.76, 95% confidence interval 0.74-0.78; and 0.41 (0.38-0.44) for telemonitoring-guided proactive care alone + patient engagement). Age <50 or >59 years and use of a nasal pillows or full-face mask were significant predictors of therapy termination; male sex, use of telemonitoring-guided proactive care (± patient engagement) and private insurance were significantly associated with lower therapy termination rates. Conclusions: Use of telemonitoring-guided proactive care and a patient engagement tool was associated with lower rates of PAP therapy termination.

Patient-reported outcomes with hypoglossal nerve stimulation for treatment of obstructive sleep apnea: a systematic review and meta-analysis.

INTRODUCTION: Hypoglossal nerve stimulation (HNS) has recently been introduced as an alternative treatment for patients with OSA. A large number of studies have demonstrated substantial changes in OSA with this therapy by reducing respiratory events and improving symptoms such as daytime sleepiness and quality of life. The objective of this review was to conduct a systematic review and meta-analysis to evaluate patient-reported outcomes and experience with HNS therapy. METHODS: A systematic literature search of MEDLINE, Cochrane, and Web of Science was performed to identify randomized controlled and observational studies reporting subjective outcomes with different HNS systems in patients with OSA. Abstracts of 406 articles were screened and a subset of 55 articles were reviewed for eligibility. Risk of bias was assessed using the ROBINS-I tool. Meta-analysis using RevMan was performed when > 2 studies were identified that reported data on a specific outcome. RESULTS: Thirty-four publications reporting data on 3785 patients with a mean follow-up of 11.8 ± 12.2 months were identified and included in the meta-analysis. The analysis revealed a pooled effect of 4.59 points improvement in daytime sleepiness as measured by the ESS questionnaire (Z = 42.82, p < .001), 2.84 points improvement in daytime functioning as measured by the FOSQ score (Z = 28.38, p < .001), and 1.77 points improvement in sleep quality as measured by the PSQI questionnaire (Z = 2.53, p = .010). Patient-reported experience was consistently positive and revealed additional relevant aspects from this perspective. CONCLUSION: HNS therapy significantly improves quality of life in patients with OSA and reliably produces clinically meaningful effects on daytime sleepiness, daytime functioning, and sleep quality. Treatment regularly meets or exceeds the minimum clinically important differences defined for the respective instruments. Additional research is needed to further investigate effects on quality of life beyond improvements in daytime sleepiness and daytime functioning.

Obstructive sleep apnea and nocturnal hypoxemia in adult patients with cystic fibrosis.

BACKGROUND: Obstructive sleep apnea (OSA), nocturnal hypoxemia and excessive daytime sleepiness (EDS) are common comorbidities in people with cystic fibrosis (pwCF). Most of the data showing this originates from children and adolescents. The aim of this study was to collect data on sleep parameters, EDS and pulmonary function from a large cohort of adult pwCF. METHODS: Full overnight polysomnography (PSG) was performed. EDS was determined using the Epworth Sleepiness Scale (ESS). Demographic and clinical data (body mass index [BMI], pulmonary function, capillary blood gases) were collected. RESULTS: A total of 52 adult pwCF were included (mean age 30.7 ± 8.0 years, mean percent predicted forced expiratory volume in 1 s [ppFEV1] of 52.1 ± 14.8). Overall AHI was in the normal range (4.5 ± 4.0/h); 21/52 pwCF (40%) had an apnea-hypopnea index > 5/h. Nocturnal hypoxemia was found in 25% of participants and this was associated with ppFEV1 (p = 0.014), awake oxygen saturation (SpO2; p = 0.021) and awake partial pressure of oxygen (pO2; p = 0.003); there were no significant differences in age, lung function and BMI were found for pwCF with versus without OSA (all p > 0.05). Eight pwCF (15%) had an ESS score > 10 (indicating EDS). OSA was best predicted by awake pO2 (area under the curve [AUC] 0.66, p = 0.048), while nocturnal hypoxemia was best predicted by ppFEV1 (AUC 0.74, p = 0.009), awake pO2 (AUC 0.76, p = 0.006) and awake SpO2 (AUC 0.71; p = 0.025). CONCLUSION: OSA, nocturnal hypoxemia and EDS were common in adult pwCF, but no strong predictors were identified. Therefore, we suggest regular PSG and ESS scoring in adult pwCF, regardless of disease severity.

Prevalence and predictors of sleep-disordered breathing in chronic heart failure: the SchlaHF-XT registry.

AIMS: Heart failure with preserved ejection fraction (HFpEF) is a condition with increasing prevalence. Sleep-disordered breathing (SDB) is an important co-morbidity in HFpEF. The SchlaHF-XT registry evaluated the sex-specific prevalence and predictors of SDB, including obstructive (OSA) and central sleep apnoea, in patients with HFpEF compared with heart failure with mildly reduced (HFmrEF) or reduced (HFrEF) ejection fraction. METHODS AND RESULTS: Consecutive adults with chronic heart failure treated according to current guidelines were enrolled. The presence of moderate-to-severe SDB (apnoea-hypopnoea index ≥15/h) was determined using Type 3 polygraphic devices. Of 3289 patients included, 2032 had HFpEF, 559 had HFmrEF, and 698 had HFrEF, of whom 34, 21, 23, and 42%, respectively, were female. Prevalence of SDB in HFpEF was high, but significantly lower than in HFmrEF or HFrEF (36% vs. 41 and 48%, respectively). Rates of SDB in males and females were 41 and 28% in HFpEF, 44 and 30% in HFmrEF, and 50 and 40% in HFrEF. The proportion of males and females with SDB who had OSA was significantly greater in those with HFpEF vs. HFrEF. Male sex, older age, higher body mass index, and New York Heart Association functional Class III/IV were significant predictors of moderate-to-severe SDB in HFpEF patients. CONCLUSIONS: Prevalence of SDB in HFpEF was high, but lower than in patients with HFmrEF or HFrEF. Moderate-to-severe SDB occurred more frequently in males than in females across the whole spectrum of heart failure. In both sexes, the proportion of OSA in SDB patients with HFpEF was higher than in those with HFrEF.

Effect of Triple Combination CFTR Modulator Therapy on Sleep in Adult Patients with Cystic Fibrosis.

BACKGROUND: Sleep-disordered breathing (SDB) and disturbed sleep are common, often underrecognized, comorbidities in people with cystic fibrosis (pwCF). OBJECTIVES: We studied the effect of CFTR triple combination therapy elexacaftor/tezacaftor/ivacaftor (ELX/TEZ/IVA) on sleep in pwCF. METHOD: This was a prospective, observational sleep study in clinically stable adult pwCF. All participants underwent overnight polysomnography (PSG), before (T0) and after (T1) initiation of CFTR modulator therapy with ELX/TEZ/IVA. In addition, pulmonary function tests, calculation of BMI, and sweat chloride testing were performed. RESULTS: Twenty-nine pwCF (mean age 32 ± 8 years; 15 female) participated in the study. Mean time between T0 and T1 was 194 ± 21 days. Total sleep time (TST) was 298 ± 40 min, with decreased sleep efficiency (SE) (76 ± 109) and increased sleep latency (SL) (73 ± 38 min). Sleep stages for NREM (N1-3) and REM sleep were within the normal range. Nocturnal respiratory events mainly occur during REM sleep (T0: AHI REM 8.3 ± 9.0/h; ODI REM 9.4 ± 10.6/h), whereas the overall AHI was normal (3.6 ± 3.7/h). After initiation of ELX/TEZ/IVA, we saw significant improvements in ppFEV1 (p < 0.001) and BMI (p < 0.001) and a reduction in sweat chloride levels (p < 0.001). In parallel, there was a reduction in AHI (p = 0.003), ODI (p = 0.001), and nocturnal respiratory rate (p < 0.001), both in total, REM and NREM sleep. Neither TST, SL, SE, nor sleep architecture was influenced (all p > 0.05). CONCLUSIONS: Initiation of ELX/TEZ/IVA resulted in significant improvements in SDB in adult pwCF.

Patient preferences in obstructive sleep apnea-a discrete choice experiment.

BACKGROUND: Obstructive sleep apnea (OSA) is one of the most common chronic sleep disorders, which can be treated by different interventions. It is known that acceptance and adherence to these therapies is influenced by a variety of factors. However, there is a limited understanding of patient preferences and decision-making in the context of OSA treatment. METHODS: A discrete choice experiment was conducted on patients with OSA recruited from a tertiary sleep center to evaluate preferences for different treatment attributes. Participants received four different choice tasks with three hypothetical treatments, each defined by seven attributes. A random-effects logit model was used to estimate the influence of the different attributes on the choice decisions. Multivariate logistic regression analysis was carried out to evaluate interactions with medical variables. RESULTS: In a cohort of 241 subjects with OSA, preferences for treatment attributes and utilities derived from them differed. Most relevant attributes were Reduction in risk of comorbidities, Improvements of daytime sleepiness, Requirement for surgery, and Occurrence of treatment-related side effects. Demographic or medical variables, such as age, gender, or apnea-hypopnea index, did not influence the choice decision. Multivariate logistic regression revealed significant differences in preferences depending on OSA disease history (p = .025) and presence of OSA symptoms (p = .033). CONCLUSIONS: The study identified preferences for attributes of OSA and their utilities from a patient perspective. Relevant differences of preferences in subgroups of patients with OSA were identified, which may be important to consider in selecting appropriate treatments that lead to high rates of acceptance and adherence.

Treatment preferences and willingness to pay in patients with obstructive sleep apnea: relevance of treatment experience.

Background: Patients with obstructive sleep apnea (OSA) most commonly receive positive airway pressure therapy (PAP) as primary treatment, which is highly effective when used consistently. Little is known about the preferences for and relevance of attributes of OSA treatments, especially of non-PAP alternatives. The aim of this study was to evaluate treatment preferences and willingness to pay (WTP) among patients with and without previous experience of OSA therapies. Methods: A discrete choice experiment and a structured survey were applied to patients presenting for overnight polysomnography at a tertiary sleep center. Medical variables were obtained from hospital case records. Results: Over a period of 4 months, 241 subjects were enrolled and answered the questionnaire (61.8% with an existing diagnosis, 38.2% with a new diagnosis). The most preferred treatment among all patients was PAP therapy (51.1%), followed by mandibular advancement devices (18.1%), hypoglossal nerve stimulation (17.2%), and medication (13.7%). Approval for the different treatments varied by gender as well as by OSA therapy experience. The importance of attributes of OSA treatment varied too, with low rates of treatment-related side effects being equally important, independent of the preferred therapy. The most often stated monthly WTP for optimal sleep was €â€¯50, with increasing age leading to lower WTP values. Conclusion: Preferences for OSA therapies vary among patients and patient subgroups. PAP therapy is the most preferred treatment, though non-PAP interventions receive high approval ratings too, particularly in treatment-naïve patients. The importance of treatment attributes varies as well, depending on the choice of preferred treatment.

Telehealth and its implementation in respiratory sleep medicine.

PURPOSE OF REVIEW: The COVID-19 pandemic has clearly demonstrated that the technological progress in digitization is also essential for the medical sector. In the field of sleep-disordered breathing, the novel eHealth methods already do offer smart solutions for currently insufficiently addressed problems. RECENT FINDINGS: In general, the potential of telemedicine tools can be focused on three basic aspects: interaction between clinicians, interaction between clinician and patient, and interaction between patient and the mobile health technology. The pandemic situation resulted in a rapid development of reimbursement for telehealth services. In recent years, evidence on the positive benefits of using telemedicine-based support as part of respiratory therapy follow-up is increasing. It is important to consider patient groups, telemedicine methodology, type of intervention, and targeting criteria in all studies conducted. SUMMARY: Given the scarcity of resources for leading common diseases, we must keep an eye on the new digitization concepts in respiratory medicine care. It must be implemented precisely, cost-effectively, and also more connecting between sectors and disciplines and at eye level with our patients. By means of patient engagement systems, an important part of modern precision medicine can be established. Digital support systems are valuable for supporting medical staff. They are not meant to replace medical staff but to facilitate their work and improve its quality.

Heart rate variability changes by non-invasive ventilation in obesity hypoventilation syndrome.

BACKGROUND: Non-invasive positive pressure ventilation (NIPPV) is known to enhance hypoventilation and is particularly adopted as a treatment for patients diagnosed with obesity hypoventilation syndrome (OHS). The augmented risk of cardiovascular morbidity is known as a side effect of OHS. AIMS: In this paper, this inference is examined that hypoventilation and the increased risk of morbidity can be diagnosed via the assessment of changes in heart rate variability (HRV). More specifically, the study investigates the effect of NIPPV on both HRV and hypoventilation among OHS patients. The linear relationship between different HRV measures and ventilation parameters is also examined. MATERIALS & METHODS: The reported results are attained via an interventional clinical trial study. HRV measures are evaluated before and after treatment, in a group of patients which are newly diagnosed with OHS and receive bi-level positive airway pressure (BiPAP) treatment for three months. RESULTS: The results are compared and interpreted via statistical analysis. DISCUSSION: Throughout the study, the relationship between hypoventilation and HRV is confirmed, as well as the effect of BiPAP on some HRV measures in both time and frequency domains. Particularly significant connections are observed between hypoventilation and low-frequency components of HRV. CONCLUSION: The enhanced respiration due to the application of BiPAP can improve the performance of autonomous nervous and cardiovascular systems, in terms of HRV. Moreover, it is suggested to consider some HRV parameters to control the cardiovascular side-effects of OHS and confine the resulting mortality rate in long term.

Sleep - the yet underappreciated player in cardiovascular diseases: A clinical review from the German Cardiac Society Working Group on Sleep Disordered Breathing.

Patients with a wide variety of cardiovascular diseases, including arterial and pulmonary hypertension, arrhythmia, coronary artery disease and heart failure, are more likely to report impaired sleep with reduced sleep duration and quality, and also, sometimes, sleep interruptions because of paroxysmal nocturnal dyspnoea or arrhythmias. Overall, objective short sleep and bad sleep quality (non-restorative sleep) and subjective long sleep duration are clearly associated with major cardiovascular diseases and fatal cardiovascular outcomes. Sleep apnoea, either obstructive or central in origin, represents the most prevalent, but only one, of many sleep-related disorders in cardiovascular patients. However, observations suggest a bidirectional relationship between sleep and cardiovascular diseases that may go beyond what can be explained based on concomitant sleep-related disorders as confounding factors. This makes sleep itself a modifiable treatment target. Therefore, this article reviews the available literature on the association of sleep with cardiovascular diseases, and discusses potential pathophysiological mechanisms. In addition, important limitations of the current assessment, quantification and interpretation of sleep in patients with cardiovascular disease, along with a discussion of suitable study designs to address future research questions and clinical implications are highlighted. There are only a few randomised controlled interventional outcome trials in this field, and some of the largest studies have failed to demonstrate improved survival with treatment (with worse outcomes in some cases). In contrast, some recent pilot studies have shown a benefit of treatment in selected patients with underlying cardiovascular diseases.

The Association of Sleep Duration and Quality with Heart Rate Variability and Blood Pressure.

BACKGROUND: The current study was conducted to evaluate the relation of sleep duration and quality with blood pressure (BP) and heart rate variability (HRV). MATERIALS AND METHODS: This cross-sectional study was carried out in 2017 among 260 staff of a university hospital in Isfahan, Iran. They were selected by multi-stage random method from different wards. Time domain spectral analysis was used to measure a number of HRV parameters. The long-term components of the HRV were estimated using the standard deviation of the normal-to-normal interval (SDNN). The square root of the mean squared differences of successive NN intervals (RMSSD) was calculated by statistical time domain measurements; SNN50, and PNN50 were measured. Pittsburg sleep quality index (PSQI) questionnaire was used to assess sleep quality. RESULTS: Higher PSQI score correlated with lower SDANN rise (OR=0.92). Fairly bad to very good subjective sleep quality had association with lower SDANN (OR=0.43). Very high sleep latency to very low sleep latency ratio had association with lower SDANN (OR=0.39) and lower PNN50 (OR= 0.44). Sleep duration and HRV parameters had no significant association. Fairly bad sleep efficiency to very good sleep efficiency ratio was correlated with lower SDANN (OR= 0.29). Very high daytime dysfunction to very low daytime dysfunction ratio had correlation with lower SDANN (OR=0.35). Very bad compared to very good subjective sleep quality had significant correlation with higher Heart rate (HR) (B=0.03). Very high sleep latency compared to no sleep latency was associated with higher HR (B=4.74). Very high compared to very low amount of sleep disturbances correlated with higher SBP levels (B=15.2). Using sleep medication less than once a week compared with no history of taking such drugs was associated with higher HR (B=16.4). CONCLUSION: Our findings showed that poor sleep quality are adversely associated with HRV, HR and BP. This finding should be considered in clinical and preventive recommendations.

The prediction of obstructive sleep apnea severity based on anthropometric and Mallampati indices.

BACKGROUND: Obstructive sleep apnea (OSA) is a common health issue with serious complications. Regarding the high cost of the polysomnography (PSG), sensitive and inexpensive screening tools are necessary. The objective of this study was to evaluate the predictive value of anthropometric and Mallampati indices for OSA severity in both genders. MATERIALS AND METHODS: In a cross-sectional study, we evaluated anthropometric data and the Mallampati classification for the patients (n = 205) with age >18 and confirmed OSA in PSG (Apnea-Hypopnea Index [AHI] >5). For predicting the severity of OSA, we applied a decision tree (C5.0) algorithm, with input and target variables considering two models (Model 1: AHI ≥15 with Mallampati >2, age >51 years, and neck circumference [NC] >36 cm and Model 2: AHI ≥30 with condition: gender = female, body mass index (BMI) >35.8, and age >44 years or gender = male, Mallampati ≥2, and abdominal circumference (AC) >112 then AHI ≥30). RESULTS: About 54.1% of the patients were male. Mallampati, age, and NCs are important factors in predicting moderate OSA. The likelihood of moderate OSA severity based on Model 1 was 94.16%. In severe OSA, Mallampati, BMI, age, AC, and gender are more predictive. In Model 2, gender had a significant role. The likelihood of severe OSA based on Model 2 in female patients was 89.98% and in male patients was 90.32%. Comparison of the sensitivity and specificity of both models showed a higher sensitivity of Model 1 (93.5%) and a higher specificity of Model 2 (89.66%). CONCLUSION: For the prediction of moderate and severe OSA, anthropometric and Mallampati indices are important factors.

Is dynamic desaturation better than a static index to quantify the mortality risk in heart failure patients with Cheyne-Stokes respiration?

Cheyne-Stokes respiration (CSR) is a periodic, highly dynamic, respiratory pattern and a known comorbidity in congestive heart failure (CHF) patients. It is generally seen as an indicator for a negative prognosis, even if no distinction in degree is known or understood. This paper aims to improve on existing attempts by creating a quantification of the behavior of the dynamic desaturation process of oxygen in the blood. We performed this work on a cohort of 11 subjects with CHF, reduced left ventricular ejection fraction, and CSR. The dynamic desaturation process was evaluated according to changes to peripheral capillary oxygenation S p O 2 resulting from highly nonlinear relationships in the ventilatory system perturbed by periodic breathing. Hypoxaemic burden expressed as a static index T 90 was compared to a novel relative desaturation index R D I , developed in this paper. While T 90 represents a single value calculated using a static cut-off value of 90 % S p O 2 , the R D I is more sensitive to dynamic influences as it uses the specific maximum change in saturation for each CSR episode. The threshold of T 90 = 22 min per night as suggested by Oldenburg et al. could not be confirmed to predict survival, but all central apneas resulting in a relative desaturation of S p O 2 above a cut-off value of 8 % were a 100 % positive predictor of mortality. The R D I proved sufficiently stable in intraindividual measurements across CSR epochs. Across the cohort, it showed a bimodal distribution for the deceased group, indicative of a possible aetiological difference. Hence, it is our conclusion that a dynamic approach to analyse desaturation of oxygen during Cheyne-Stokes respiration is to be strongly favoured over a static approach to analysis.

Efficacy of telemedical interventional management in patients with heart failure (TIM-HF2): a randomised, controlled, parallel-group, unmasked trial.

BACKGROUND: Remote patient management in patients with heart failure might help to detect early signs and symptoms of cardiac decompensation, thus enabling a prompt initiation of the appropriate treatment and care before a full manifestation of a heart failure decompensation. We aimed to investigate the efficacy of our remote patient management intervention on mortality and morbidity in a well defined heart failure population. METHODS: The Telemedical Interventional Management in Heart Failure II (TIM-HF2) trial was a prospective, randomised, controlled, parallel-group, unmasked (with randomisation concealment), multicentre trial with pragmatic elements introduced for data collection. The trial was done in Germany, and patients were recruited from hospitals and cardiology practices. Eligible patients had heart failure, were in New York Heart Association class II or III, had been admitted to hospital for heart failure within 12 months before randomisation, and had a left ventricular ejection fraction (LVEF) of 45% or lower (or if higher than 45%, oral diuretics were being prescribed). Patients with major depression were excluded. Patients were randomly assigned (1:1) using a secure web-based system to either remote patient management plus usual care or to usual care only and were followed up for a maximum of 393 days. The primary outcome was percentage of days lost due to unplanned cardiovascular hospital admissions or all-cause death, analysed in the full analysis set. Key secondary outcomes were all-cause and cardiovascular mortality. This study is registered with ClinicalTrials.gov, number NCT01878630, and has now been completed. FINDINGS: Between Aug 13, 2013, and May 12, 2017, 1571 patients were randomly assigned to remote patient management (n=796) or usual care (n=775). Of these 1571 patients, 765 in the remote patient management group and 773 in the usual care group started their assigned care, and were included in the full analysis set. The percentage of days lost due to unplanned cardiovascular hospital admissions and all-cause death was 4·88% (95% CI 4·55-5·23) in the remote patient management group and 6·64% (6·19-7·13) in the usual care group (ratio 0·80, 95% CI 0·65-1·00; p=0·0460). Patients assigned to remote patient management lost a mean of 17·8 days (95% CI 16·6-19·1) per year compared with 24·2 days (22·6-26·0) per year for patients assigned to usual care. The all-cause death rate was 7·86 (95% CI 6·14-10·10) per 100 person-years of follow-up in the remote patient management group compared with 11·34 (9·21-13·95) per 100 person-years of follow-up in the usual care group (hazard ratio [HR] 0·70, 95% CI 0·50-0·96; p=0·0280). Cardiovascular mortality was not significantly different between the two groups (HR 0·671, 95% CI 0·45-1·01; p=0·0560). INTERPRETATION: The TIM-HF2 trial suggests that a structured remote patient management intervention, when used in a well defined heart failure population, could reduce the percentage of days lost due to unplanned cardiovascular hospital admissions and all-cause mortality. FUNDING: German Federal Ministry of Education and Research.

Comparison of Berlin Questionnaire, STOP-Bang, and Epworth Sleepiness Scale for Diagnosing Obstructive Sleep Apnea in Persian Patients.

BACKGROUND: Obstructive sleep apnea (OSA) is a common disorder characterized by snoring, daytime sleepiness, fatigue, and repeated termination of airflow (apnea). Standard polysomnography (PSG) is diagnostic gold standard for OSA. PSG is expensive and not available everywhere. To identify the best OSA questionnaire for screening in Persian population, we compared Berlin, STOP-BANG, and Epworth Sleepiness Scale (ESS). METHODS: In a cross-sectional study conducted on 400 adult patients suspected of OSA in Bamdad Respiratory Research Center, patients completed three questionnaires. For each questionnaire, patients were divided into high risk and low risk. Then, PSG was performed for all patients. According to PSG, patients categorized into without OSA (apnea-hypopnea index [AHI] <5), mild OSA (15> AHI ≥5), moderate OSA (30> AHI ≥15), and severe OSA (AHI ≥30). Based on questionnaires and PSG results, predictive parameters for screening tests were calculated. RESULTS: There were 234 (58.5%) males and 166 (41.5%) females in study population. Mean age of patients was 49.29 ± 9.75 standard deviation years. There was significant association between age with OSA (P = 0.005) and between body mass index (BMI) and neck circumference, with moderate and severe OSA (P < 0.001). Sensitivities of Berlin, STOP-BANG, and ESS were 86.42%, 81.46%, and 59%, respectively. Specificities of Berlin, STOP-BANG, and ESS were 52.94%, 82.35%, and 76.47%, respectively. CONCLUSIONS: This study suggested that Berlin and STOP-BANG are more sensitive and accurate than ESS for OSA screening in Iran.

Comparison of Therapeutic Approaches to Addicted Patients with Central Sleep Apnea.

BACKGROUND: Nowadays, the most practical approaches used to treat sleep apnea, are Continuous Positive Airway Pressure (CPAP), Bi-level Positive Airway Pressure therapy (BPAP), supplemental O2, servoventilation and/or a combination of these approaches simultaneously. However, each leads to different consequences in opioid related Central Sleep Apnea (CSA) patients. Given the high prevalence of CSA and frequently use of opioids worldwide, it seems that evaluation of the condition in these patients is required to determine their responsiveness to the above mentioned treatments and to choose the most appropriate therapy. MATERIALS AND METHODS: This longitudinal cross-sectional study included 41 opioid related CSA patients who underwent a step-by-step protocol (including CPAP, CPAP + O2 and BPAP) in which if the patient was nonresponsive to a treatment, the next therapy was applied. If the patient was nonresponsive to all of these approaches, only oxygen was administered. Finally, the collected data were analyzed with SPSS software (ver. 22). RESULTS: Among 41 participants, the responsiveness to CPAP, CPAP+O2 and BPAP were 41.5%, 14.6% and 39%, respectively versus 4.9% nonresponsive patients to all above mentioned therapies. In patients with CSA and opium addiction, the CPAP and BPAP were the most effective treatments. In this group of patients, better response in the presence of higher Apnea-Hypopnea Index (AHI) was observed to BPAP, whereas better response in patients with lower AHI was to CPAP+O2. CONCLUSION: Accordingly, CPAP and BPAP are successful approaches to treat opioid related CSA patients in various medical conditions including long-run addiction course, concurrent smoking and addiction but it appears that further studies are essential.

Nocturnal heart rate variation in diabetic and non-diabetic patients with sleep apnea syndrome.

OBJECTIVES: Heart rate variability (HRV) analysis is used for the evaluation of autonomic function in the cardiovascular system. Decreased HRV is associated with disorders affecting the autonomous system such as diabetes mellitus (DM) and obstructive sleep apnea (OSA). Previous studies have shown an association between OSA and DM. However, the interrelationships of HRV with OSA and DM are not well known. The aim of this study was to assess nocturnal HRV in patients who suffered from OSA with and without DM. METHODS: Sixty patients with OSA (27 with DM and 33 non-DM) underwent polysomnography for eight hours starting at midnight. From electrocardiogram (ECG) recordings taken as a part of polysomnography, time-domain and frequency-domain HRV parameters were evaluated to compare patients with regard to nocturnal HRV components such as low frequency (LF) and high frequency (HF), apnea-hypopnea index (AHI) and sleep parameters. RESULTS: In the non-DM group, a direct relationship was observed between AHI and HRV rather than very low frequency (VLF) and LF/HF variables. This relationship was just significant between AHI and standard deviation of five-min average of normal R-R intervals and adjacent R-R intervals differing by 0.50 ms over 24 h (p < 0.05). In the DM group, the correlation between AHI and HRV parameters except HF and waking frequency was direct and non-significant. Intergroup comparison showed a significant difference between groups regarding AHI and HRV-index, LF and VLF (p < 0.05). CONCLUSIONS: DM can affect HRV; however, this is not the case in OSA patients. This means that in the presence of OSA, the DM effect on HRV disappears.

Prognostic value of serial six-minute walk tests using tele-accelerometry in patients with chronic heart failure: A pre-specified sub-study of the TIM-HF-Trial.

BACKGROUND: The six-minute walk test (6MWT) is an established functional test assessing exercise capacity and is used to predict clinical prognosis in patients with chronic heart failure (HF). Tele-accelerometry is a novel approach to activity monitoring using telemedical data transfer and allows a Tele-6MWT to be performed in an outpatient setting. It offers patients the option of performing simple serial follow-up tests in their own home. AIMS: The aim of this study was to investigate the prognostic value of serial Tele-6MWTs using tele-accelerometry in patients with HF. DESIGN/METHODS: In this proof-of-concept study, 155 patients with HF completed the Tele-6MWT in an outdoor setting once per month over a period of 0.25-21 months. We analysed the differences in the number of steps over time to predict hospitalization as a result of HF or death. RESULTS: Patients with at least one event (n = 31) recorded a lower number of steps and a shorter distance in Tele-6MWT at baseline compared with patients who remained event-free (n = 124) (540.1 ± 78.4 steps vs. 601.8 ± 76.7 steps, P < 0.001 respectively; 353.2 ± 82.4 m vs. 418.8 ± 95.6 m, P < 0.001). Patients (n = 19) who performed more than one Tele-6MWT prior to a clinical event showed no significant difference in the number of steps, regardless of whether the baseline test was compared with the last Tele-6MWT before the event or with the last two tests before the event. CONCLUSION: Tele-6MWT has a high predictive value with respect to hospitalization as a result of HF or death from any cause and the results were comparable with the prognostic impact of a conventional 6MWT. Therefore Tele-6MWT may be used as alternative test method in the home environment. However, there is no added prognostic value of repeating Tele-6MWTs on a monthly basis.

Comparison of effects of OSA treatment by MAD and by CPAP on cardiac autonomic function during daytime.

PURPOSE: The present study compared the effects of mandibular advancement therapy (MAD) with continuous positive airway pressure therapy (CPAP) on daytime cardiac autonomic modulation in a wide range of obstructive sleep apnea (OSA) patients under controlled conditions in a randomized, two-period crossover trial. METHODS: Forty OSA patients underwent treatment with MAD and with CPAP for 12 weeks each. At baseline and after each treatment period, patients were assessed by polysomnography as well as by a daytime cardiac autonomic function test that measured heart rate variability (HRV), continuous blood pressure (BP), and baroreceptor sensitivity (BRS) under conditions of spontaneous breathing, with breathing at 6, 12, and 15/min. RESULTS: Both CPAP and MAD therapy substantially eliminated apneas and hypopneas. CPAP had a greater effect. During daytime with all four conditions of controlled breathing, three-minute mean values of continuous diastolic BP were significantly reduced for both MAD and CPAP therapy. At the same time, selective increases due to therapy with MAD were found for HRV high frequency (HF) values. No changes were observed for BRS in either therapy mode. CONCLUSIONS: These findings indicate that both MAD and CPAP result in similar beneficial changes in cardiac autonomic function during daytime, especially in blood pressure. CPAP is more effective than MAD in eliminating respiratory events.