Continuous heart monitoring in patients with pulmonary hypertension smartwatches and direct transmission to their electronic health records: A trial design.

BACKGROUND: Pulmonary hypertension is a progressive disease for which early treatment interventions are essential. Traditionally, patients undergo periodic clinical assessments. However, recent advances in wearable technology could improve the quality and efficiency of follow-up monitoring in patients with pulmonary hypertension. TRIAL DESIGN: To our knowledge, this is the first study describing direct data transmission from a smartwatch to patients' electronic health records. It implements a novel update and customised program to continuously and automatically transmit data from a smartwatch to the patient's electronic healthcare records. It will evaluate continuous monitoring in patients with pulmonary hypertension and monitor their physical activity time, heart rate variability, and heart rate at rest and during physical activity via a smartwatch. It will also evaluate the data transmission method, and its data will be assessed by the treating physicians supplemental to clinical practice. Smartwatch integration promises numerous advantages: comprehensive cardiovascular monitoring and improved patient experience. Our continuous smartwatch monitoring approach offers a solution for earlier detection of clinical worsening and could be included as a combined endpoint in future clinical trials. It could improve patient empowerment, enhance precision medicine, and reduce hospitalisations. The user-friendly smartwatch is designed to minimise disruption in daily life. CONCLUSION: The ability to transfer real-time data from wearable devices to electronic health records could help to transform the treatment of patients with pulmonary hypertension and their follow-up monitoring outside a clinical setting, enhancing the efficiency of healthcare delivery.

Transdermal sensor features correlate with ecological momentary assessment drinking reports and predict alcohol-related consequences in young adults' natural settings.

BACKGROUND: Wearable transdermal alcohol concentration (TAC) sensors allow passive monitoring of alcohol concentration in natural settings and measurement of multiple features from drinking episodes, including peak intoxication level, speed of intoxication (absorption rate) and elimination, and duration. These passively collected features extend commonly used self-reported drink counts and may facilitate the prediction of alcohol-related consequences in natural settings, aiding risk stratification and prevention efforts. METHOD: A total of 222 young adults aged 21-29 (M age = 22.3, 64% female, 79% non-Hispanic white, 84% undergraduates) who regularly drink heavily participated in a 5-day study that included the ecological momentary assessment (EMA) of alcohol consumption (daily morning reports and participant-initiated episodic EMA sequences) and the wearing of TAC sensors (SCRAM-CAM anklets). The analytic sample contained 218 participants and 1274 days (including 554 self-reported drinking days). Five features-area under the curve (AUC), peak TAC, rise rate (rate of absorption), fall rate (rate of elimination), and duration-were extracted from TAC-positive trajectories for each drinking day. Day- and person-level associations of TAC features with drink counts (morning and episodic EMA) and alcohol-related consequences were tested using multilevel modeling. RESULTS: TAC features were strongly associated with morning drink reports (r = 0.6-0.7) but only moderately associated with episodic EMA drink counts (r = 0.3-0.5) at both day and person levels. Higher peaks, larger AUCs, faster rise rates, and faster fall rates were significantly predictive of day-level alcohol-related consequences after adjusting for both morning and episodic EMA drink counts in separate models. Person means of TAC features added little above daily scores to the prediction of alcohol-related consequences. CONCLUSIONS: These results support the utility of TAC sensors in studies of alcohol misuse among young adults in natural settings and outline the specific TAC features that contribute to the day-level prediction of alcohol-related consequences. TAC sensors provide a passive option for obtaining valid and unique information predictive of drinking risk in natural settings.

Disinvestment in the presence of uncertainty: Description of a novel, multi-group, disinvestment trial design and protocol for an application to reduce or cease use of mobilisation alarms for preventing falls in hospitals.

Disinvestment is the removal or reduction of previously provided practices or services, and has typically been undertaken where a practice or service has been clearly shown to be ineffective, inefficient and/or harmful. However, practices and services that have uncertain evidence of effectiveness, efficiency and safety can also be considered as candidates for disinvestment. Disinvestment from these practices and services is risky as they may yet prove to be beneficial if further evidence becomes available. A novel research approach has previously been described for this situation, allowing disinvestment to take place while simultaneously generating evidence previously missing from consideration. In this paper, we describe how this approach can be expanded to situations where three or more conditions are of relevance, and describe the protocol for a trial examining the reduction and elimination of use of mobilisation alarms on hospital wards to prevent patient falls. Our approach utilises a 3-group, concurrent, non-inferiority, stepped wedge, randomised design with an embedded parallel, cluster randomised design. Eighteen hospital wards with high rates of alarm use (≥3%) will be paired within their health service and randomly allocated to a calendar month when they will transition to a "Reduced" (<3%) or "Eliminated" (0%) mobilisation alarm condition. Dynamic randomisation will be used to determine which ward in each pair will be allocated to either the reduced or eliminated condition to promote equivalence between wards for the embedded parallel, cluster randomised component of the design. A project governance committee will set non-inferiority margins. The primary outcome will be rates of falls. Secondary clinical, process, safety, and economic outcomes will be collected and a concurrent economic evaluation undertaken.

Rationale and design of a digital trial using smartphones to detect subclinical atrial fibrillation in a population at risk: The eHealth-based bavarian alternative detection of Atrial Fibrillation (eBRAVE-AF) trial.

Current guidelines recommend opportunistic screening for subclinical atrial fibrillation (AF) taking advantage of e-health-based technologies. However, the efficacy of a fully scalable e-health-based strategy for AF detection in a head-to-head comparison with routine symptom-based screening is unknown. eBRAVE-AF is an investigator-initiated, digital, prospective, randomized, siteless, open-label, cross-over study to evaluate an e-health-based strategy for detection of AF in a real-world setting. 67,488 policyholders of a large German health insurance company (Versicherungskammer Bayern, Germany) selected by age ≥ 50 years and a CHA2DS2-VASc score ≥ 1 (females ≥2) are invited to participate. Subjects with known AF or on treatment with oral anticoagulation are excluded. After obtaining electronic informed consent, at least 4,400 participants will be randomly assigned to an e-health-based screening strategy or routine symptom-based screening. The e-health-based strategy consists of repetitive one-minute photoplethysmographic (PPG) pulse wave assessments using a certified smartphone app (Preventicus Heartbeats, Preventicus, Jena, Germany), followed by a confirmatory 14-day ECG patch (CardioMem CM 100 XT, Getemed, Teltow, Germany) in case of abnormal findings. After 6 months, participants are crossed over to the other study arm. Primary endpoint is the incidence of newly diagnosed AF leading to oral anticoagulation indicated by an independent physician. Clinical follow-up will be at least 12 months. In both groups, follow-up is performed by 4-week app-based questionnaires, personal contact in case of abnormal findings, and matching with claim-based insurance data and medical reports. At time of writing enrollment is completed. First results are expected to be available in mid-2021.

Cost-Effectiveness of Vioptix versus Clinical Examination for Flap Monitoring of Autologous Free Tissue Breast Reconstruction.

BACKGROUND: Vioptix is a near-infrared spectroscopy tissue oximetry technology that allows for noninvasive monitoring of flap perfusion. Despite the reported benefits of Vioptix, the cost-effectiveness of this flap monitoring technology has not been compared to clinical examination alone. METHODS: A cost-effectiveness model, from the patient perspective, was constructed with two treatment arms: clinical examination versus clinical examination combined with Vioptix for flap monitoring after autologous, free flap breast reconstruction. Costs, utilities, and other model inputs were identified from the literature. One-way and probabilistic sensitivity analyses were performed. Gamma distributions were created for cost variables, and beta distributions were created for probability variables. An incremental cost-effectiveness ratio under $50,000 per quality-adjusted life-year (QALY) was considered cost-effective. All analyses were performed using TreeAge Pro (Williamstown, Mass.). RESULTS: Mean cost of autologous free tissue transfer breast reconstruction with clinical examination-based flap monitoring was found to be $37,561 with an effectiveness of 0.79, whereas the mean cost of clinical examination with Vioptix for flap monitoring was $39,361 with effectiveness of 0.82. This yielded an incremental cost-effectiveness ratio of $60,507 for clinical examination combined with Vioptix for flap monitoring. One-way sensitivity analysis revealed that clinical examination with Vioptix became cost-effective when the cost of Vioptix was less than $1487. Probabilistic sensitivity analysis found that clinical examination was cost-effective in 86.5 percent of cases. CONCLUSION: Although clinical examination combined with Vioptix is minimally more effective for flap monitoring after autologous, free flap breast reconstruction, clinical examination alone is the more cost-effective flap monitoring option.

Low-Cost Sensors and Biological Signals.

Low-cost sensors, i [...].

Fall risk assessment in the wild: A critical examination of wearable sensor use in free-living conditions.

BACKGROUND: Despite advances in laboratory-based supervised fall risk assessment methods (FRAs), falls still remain a major public health problem. This can be due to the alteration of behavior in laboratory due to the awareness of being observed (i.e., Hawthorne effect), the multifactorial complex etiology of falls, and our limited understanding of human behaviour in natural environments, or in the' wild'. To address these imitations, a growing body of literature has focused on free-living wearable-sensor-based FRAs. The objective of this narrative literature review is to discuss papers investigating natural data collected by wearable sensors for a duration of at least 24 h to identify fall-prone older adults. METHODS: Databases (Scopus, PubMed and Google Scholar) were searched for studies based on a rigorous search strategy. RESULTS: Twenty-four journal papers were selected, in which inertial sensors were the only wearable system employed for FRA in the wild. Gait was the most-investigated activity; but sitting, standing, lying, transitions and gait events, such as turns and missteps, were also explored. A multitude of free-living fall predictors (FLFPs), e.g., the quantity of daily steps, were extracted from activity bouts and events. FLFPs were further categorized into discrete domains (e.g., pace, complexity) defined by conceptual or data-driven models. Heterogeneity was found within the reviewed studies, which includes variance in: terminology (e.g., quantity vs macro), hyperparameters to define/estimate FLFPs, models and domains, and data processing approaches (e.g., the cut-off thresholds to define an ambulatory bout). These inconsistencies led to different results for similar FLFPs, limiting the ability to interpret and compare the evidence. CONCLUSION: Free-living FRA is a promising avenue for fall prevention. Achieving a harmonized model is necessary to systematically address the inconsistencies in the field and identify FLFPs with the highest predictive values for falls to eventually address intervention programs and fall prevention.

A new implantable tool for repeated assessment of supraventricular electrophysiology and atrial fibrillation susceptibility in freely moving rats.

The complex pathophysiology of atrial fibrillation (AF) is governed by multiple risk factors in ways that are still elusive. Basic electrophysiological properties, including atrial effective refractory period (AERP) and conduction velocity, are major factors determining the susceptibility of the atrial myocardium to AF. Although there is a great need for affordable animal models in this field of research, in vivo rodent studies are limited by technical challenges. Recently, we introduced an implantable system for long-term assessment of AF susceptibility in ambulatory rats. However, technical considerations did not allow us to perform concomitant supraventricular electrophysiology measurements. Here, we designed a novel quadripolar electrode specifically adapted for comprehensive atrial studies in ambulatory rats. Electrodes were fabricated from medical-grade silicone, four platinum-iridium poles, and stainless-steel fixating pins. Initial quality validation was performed ex vivo, followed by implantation in adult rats and repeated electrophysiological studies 1, 4, and 8 wk postimplantation. Capture threshold was stable. Baseline AERP values (38.1 ± 2.3 and 39.5 ± 2.0 using 70-ms and 120-ms S1-S1 cycle lengths, respectively) confirmed the expected absence of rate adaptation in the unanesthetized state and validated our prediction that markedly higher values reported under anesthesia are nonphysiological. Evaluation of AF substrate in parallel with electrophysiological parameters validated our recent finding of a gradual increase in AF susceptibility over time and demonstrated that this phenomenon is associated with an electrical remodeling process characterized by AERP shortening. Our findings indicate that the miniature quadripolar electrode is a potent new tool, which opens a window of opportunities for better utilization of rats in AF research.NEW & NOTEWORTHY Rodents are increasingly used in AF research. However, technical challenges restrict long-term supraventricular electrophysiology studies in these species. Here, we developed an implantable electrode adapted for such studies in the rat. Our findings indicate that this new tool is effective for long-term follow-up of critical parameters such as atrial refractoriness. Obtained data shed light on the normal electrophysiology and on the increased AF susceptibility that develops in rats with implanted atrial electrodes over time.

Portable Device for the Measurement and Assessment of the Human Equilibrium.

This work presents the design and development of a new alternative tool to measure the Center of Pressure (CoP) displacements, intended to evaluate the human balance. The device is based on a modified commercial balance board used for video games, resulting in a low-cost, portable device capable of computing the CoP, providing 24 of the most used indexes to test the human balance. The proposed standalone device runs on rechargeable batteries, weighs only 3.5 kg, and has a data storage capacity for over 1000 tests. Visual and auditory instructions assist its user interface. Thus, contrary to the commercial systems designed for laboratory use, this device enables the measurement of quantitative balance parameters in non-laboratory places, allowing the study of the balance of vulnerable populations directly on their typical environments. To evaluate the device, 20 older adults (68.60 ± 1.23 years) were tested, and the resulting values were compared with a similar study using a force platform; 19 indexes showed a similarity with those reported using force platform and 12 of these were statistically equivalent. The proposed device represents an open-source alternative tool for researchers and healthcare personnel to acquire reliable data to evaluate human balance.

An Objective Methodology for the Selection of a Device for Continuous Mobility Assessment.

Continuous monitoring by wearable technology is ideal for quantifying mobility outcomes in "real-world" conditions. Concurrent factors such as validity, usability, and acceptability of such technology need to be accounted for when choosing a monitoring device. This study proposes a bespoke methodology focused on defining a decision matrix to allow for effective decision making. A weighting system based on responses (n = 69) from a purpose-built questionnaire circulated within the IMI Mobilise-D consortium and its external collaborators was established, accounting for respondents' background and level of expertise in using wearables in clinical practice. Four domains (concurrent validity, CV; human factors, HF; wearability and usability, WU; and data capture process, CP), associated evaluation criteria, and scores were established through literature research and group discussions. While the CV was perceived as the most relevant domain (37%), the others were also considered highly relevant (WU: 30%, HF: 17%, CP: 16%). Respondents (~90%) preferred a hidden fixation and identified the lower back as an ideal sensor location for mobility outcomes. Overall, this study provides a novel, holistic, objective, as well as a standardized approach accounting for complementary aspects that should be considered by professionals and researchers when selecting a solution for continuous mobility monitoring.

Design of the Pregnancy REmote MOnitoring II study (PREMOM II): a multicenter, randomized controlled trial of remote monitoring for gestational hypertensive disorders.

BACKGROUND: Observational data from the retrospective, non-randomized Pregnancy REmote MOnitoring I (PREMOM I) study showed that remote monitoring (RM) may be beneficial for prenatal observation of women at risk for gestational hypertensive disorders (GHD) in terms of clinical outcomes, health economics, and stakeholder perceptions. PREMOM II is a prospective, randomized, multicenter follow-up study that was performed to explore these promising results. METHODS: After providing written consent, 3922 pregnant women aged ≥18 years who are at increased risk of developing GHD will be randomized (1:1:1 ratio) to (a) conventional care (control group), (b) a patient self-monitoring group, and (c) a midwife-assisted RM group. The women in each group will be further divided (1:1 ratio) to evaluate the outcomes of targeted or non-targeted (conventional) antihypertensive medication. Women will be recruited in five hospitals in Flanders, Belgium: Ziekenhuis Oost-Limburg, Universitaire Ziekenhuis Antwerpen, Universitaire Ziekenhuis Leuven, AZ Sint Jan Brugge-Oostende, and AZ Sint Lucas Brugge. The primary outcomes are: (1) numbers and types of prenatal visits; (2) maternal outcomes; (3) neonatal outcomes; (4) the applicability and performance of RM; and (5) compliance with RM and self-monitoring. The secondary outcomes are: (1) cost-effectiveness and willingness to pay; (2) patient-reported outcome measures (PROMS) questionnaires on the experiences of the participants; and (3) the maternal and perinatal outcomes according to the type of antihypertensive medication. Demographic, and maternal and neonatal outcomes are collected from the patients' electronic records. Blood pressure and compliance rate will be obtained from an online digital coordination platform for remote data handling. Information about the healthcare-related costs will be obtained from the National Coordination Committee of Belgian Health Insurance Companies (Intermutualistisch Agentschap). PROMS will be assessed using validated questionnaires. DISCUSSION: To our knowledge, this is the first randomized trial comparing midwife-assisted RM and self-monitoring of prenatal blood pressure versus conventional management among women at increased risk of GHD. Positive results of this study may lead to a practical framework for caregivers, hospital management, and payers to introduce RM into the prenatal care programs of high-risk pregnancies. TRIAL REGISTRATION: This study was registered on clinicaltrials.gov , identification number NCT04031430. Registered 24 July 2019, https://clinicaltrials.gov/ct2/show/NCT04031430?cond=premom+ii&draw=2&rank=1 .

New strategies of physical activity assessment in cystic fibrosis: a pilot study.

BACKGROUND: Regular physical activity (PA) is a valued part of cystic fibrosis (CF) care. Although the accelerometer, SenseWear Armband (SWA), accurately measures habitual PA in CF, it is mostly used for research purposes. For the first time, we analyzed different methods of measuring PA in daily life by the use of smartphones and other electronic devices such as smartwatch and Fitbit. METHODS: Twenty-four stable adults with CF (mean age 37.5 ± 11.5SD yrs.; FEV1 58 ± 19% predicted, BMI 22.9 ± 3.2) were studied. Daily PA was monitored for seven consecutive days. All patients wore the accelerometer SWA and at the same time they monitored PA with the electronic device they used routinely. They were allocated into one of four arms according to their device: Smartwatch, Fitbit, Android smartphones and iOS smartphones. PA related measurements included: duration of PA, energy expenditure, number of steps. RESULTS: There was a good agreement between SWA and Fitbit for number of steps (p = 0.605) and energy expenditure (p = 0.143). iOS smartphones were similar to SWA in monitoring the number of steps (p = 0.911). Significant differences were found between SWA and both Smartwatch and Android smartphones. CONCLUSIONS: Fitbit and iOS smartphones seem to be a valuable approach to monitor daily PA. They provide a good performance to measure step number compared to SWA.

A Wearable Stethoscope for Long-Term Ambulatory Respiratory Health Monitoring.

Lung sounds acquired by stethoscopes are extensively used in diagnosing and differentiating respiratory diseases. Although an extensive know-how has been built to interpret these sounds and identify diseases associated with certain patterns, its effective use is limited to individual experience of practitioners. This user-dependency manifests itself as a factor impeding the digital transformation of this valuable diagnostic tool, which can improve patient outcomes by continuous long-term respiratory monitoring under real-life conditions. Particularly patients suffering from respiratory diseases with progressive nature, such as chronic obstructive pulmonary diseases, are expected to benefit from long-term monitoring. Recently, the COVID-19 pandemic has also shown the lack of respiratory monitoring systems which are ready to deploy in operational conditions while requiring minimal patient education. To address particularly the latter subject, in this article, we present a sound acquisition module which can be integrated into a dedicated garment; thus, minimizing the role of the patient for positioning the stethoscope and applying the appropriate pressure. We have implemented a diaphragm-less acousto-electric transducer by stacking a silicone rubber and a piezoelectric film to capture thoracic sounds with minimum attenuation. Furthermore, we benchmarked our device with an electronic stethoscope widely used in clinical practice to quantify its performance.

Evaluating the Impact of Freespira on Panic Disorder Patients' Health Outcomes and Healthcare Costs within the Allegheny Health Network.

Panic disorder (PD) is a debilitating condition that drives medical spending at least twice as high as medically matched controls. Excessive utilization of healthcare resources comes from emergency department (ED), medications, diagnostic testing, and physician visits. Freespira is an FDA-cleared digital therapeutic that treats PD and panic attacks (PA) by correcting underlying abnormal respiratory physiology. Efficacy of Freespira has been established in prior studies. This paper reports on a quality improvement program that investigated whether treating PD patients with Freespira would reduce medical costs and improve outcomes over 12-months. Panic symptoms were assessed using the Panic Disorder Severity Scale (PDSS). Pre-and post-treatment insurance claims determined costs. At baseline, mean Clinician Global Impression (CGI-S) was 4.4 (moderately/markedly ill), mean PDSS was 14.4 and mean PA frequency/week was 2 (range 0-5). Immediately post-treatment (week 5) mean CGI-S, PDSS and weekly PA frequency declined to 2.8 (borderline/mildly ill, 4.9 (remission) and 0.2 (range 0-2) respectively, p < 0.001. 82% reported PDSS decrease of ≥ 40% (clinically significant), 86% were PA-free. One-year post treatment mean CGI-S, PDSS and PA remained low at 2.1, 4.4, and 0.3 (range 0-1) respectively. 91% had PDSS decrease of ≥ 40%, 73% were PA-free. The majority of patients were panic attack free and/or reduced their symptoms and avoidance behaviors 1-year post Freespira treatment. Mean overall medical costs were reduced by 35% from $548 to $358 PMPM (per member per month) or an annual reduction of $2280. at 12 months post-treatment. There was a 65% reduction in ED costs from $87 to $30 PMPM. Median pharmacy costs were reduced by 68% from $73 to $23 PMPM.

A Wristwatch-Based Wireless Sensor Platform for IoT Health Monitoring Applications.

A wristwatch-based wireless sensor platform for IoT wearable health monitoring applications is presented. The paper describes the platform in detail, with a particular focus given to the design of a novel and compact wireless sub-system for 868 MHz wristwatch applications. An example application using the developed platform is discussed for arterial oxygen saturation (SpO2) and heart rate measurement using optical photoplethysmography (PPG). A comparison of the wireless performance in the 868 MHz and the 2.45 GHz bands is performed. Another contribution of this work is the development of a highly integrated 868 MHz antenna. The antenna structure is printed on the surface of a wristwatch enclosure using laser direct structuring (LDS) technology. At 868 MHz, a low specific absorption rate (SAR) of less than 0.1% of the maximum permissible limit in the simulation is demonstrated. The measured on-body prototype antenna exhibits a -10 dB impedance bandwidth of 36 MHz, a peak realized gain of -4.86 dBi and a radiation efficiency of 14.53% at 868 MHz. To evaluate the performance of the developed 868 MHz sensor platform, the wireless communication range measurements are performed in an indoor environment and compared with a commercial Bluetooth wristwatch device.

DYSKIMOT: An Ultra-Low-Cost Inertial Sensor to Assess Head's Rotational Kinematics in Adults during the Didren-Laser Test.

Various noninvasive measurement devices can be used to assess cervical motion. The size, complexity, and cost of gold-standard systems make them not suited to clinical practice, and actually difficult to use outside a dedicated laboratory. Nowadays, ultra-low-cost inertial measurement units are available, but without any packaging or a user-friendly interface. The so-called DYSKIMOT is a home-designed, small-sized, motion sensor based on the latter technology, aiming at being used by clinicians in "real-life situations". DYSKIMOT was compared with a gold-standard optoelectronic system (Elite). Our goal was to evaluate the DYSKIMOT accuracy in assessing fast head rotations kinematics. Kinematics was simultaneously recorded by systems during the execution of the DidRen Laser test and performed by 15 participants and nine patients. Kinematic variables were computed from the position, speed and acceleration time series. Two-way ANOVA, Passing-Bablok regressions, and dynamic time warping analysis showed good to excellent agreement between Elite and DYSKIMOT, both at the qualitative level of the time series shape and at the quantitative level of peculiar kinematical events' measured values. In conclusion, DYSKIMOT sensor is as relevant as a gold-standard system to assess kinematical features during fast head rotations in participants and patients, demonstrating its usefulness in both clinical practice and research environments.

Assessment of Mandibular Movement Monitoring With Machine Learning Analysis for the Diagnosis of Obstructive Sleep Apnea.

Importance: Given the high prevalence of obstructive sleep apnea (OSA), there is a need for simpler and automated diagnostic approaches. Objective: To evaluate whether mandibular movement (MM) monitoring during sleep coupled with an automated analysis by machine learning is appropriate for OSA diagnosis. Design, Setting, and Participants: Diagnostic study of adults undergoing overnight in-laboratory polysomnography (PSG) as the reference method compared with simultaneous MM monitoring at a sleep clinic in an academic institution (Sleep Laboratory, Centre Hospitalier Universitaire Université Catholique de Louvain Namur Site Sainte-Elisabeth, Namur, Belgium). Patients with suspected OSA were enrolled from July 5, 2017, to October 31, 2018. Main Outcomes and Measures: Obstructive sleep apnea diagnosis required either evoking signs or symptoms or related medical or psychiatric comorbidities coupled with a PSG-derived respiratory disturbance index (PSG-RDI) of at least 5 events/h. A PSG-RDI of at least 15 events/h satisfied the diagnosis criteria even in the absence of associated symptoms or comorbidities. Patients who did not meet these criteria were classified as not having OSA. Agreement analysis and diagnostic performance were assessed by Bland-Altman plot comparing PSG-RDI and the Sunrise system RDI (Sr-RDI) with diagnosis threshold optimization via receiver operating characteristic curves, allowing for evaluation of the device sensitivity and specificity in detecting OSA at 5 events/h and 15 events/h. Results: Among 376 consecutive adults with suspected OSA, the mean (SD) age was 49.7 (13.2) years, the mean (SD) body mass index was 31.0 (7.1), and 207 (55.1%) were men. Reliable agreement was found between PSG-RDI and Sr-RDI in patients without OSA (n = 46; mean difference, 1.31; 95% CI, -1.05 to 3.66 events/h) and in patients with OSA with a PSG-RDI of at least 5 events/h with symptoms (n = 107; mean difference, -0.69; 95% CI, -3.77 to 2.38 events/h). An Sr-RDI underestimation of -11.74 (95% CI, -20.83 to -2.67) events/h in patients with OSA with a PSG-RDI of at least 15 events/h was detected and corrected by optimization of the Sunrise system diagnostic threshold. The Sr-RDI showed diagnostic capability, with areas under the receiver operating characteristic curve of 0.95 (95% CI, 0.92-0.96) and 0.93 (95% CI, 0.90-0.93) for corresponding PSG-RDIs of 5 events/h and 15 events/h, respectively. At the 2 optimal cutoffs of 7.63 events/h and 12.65 events/h, Sr-RDI had accuracy of 0.92 (95% CI, 0.90-0.94) and 0.88 (95% CI, 0.86-0.90) as well as posttest probabilities of 0.99 (95% CI, 0.99-0.99) and 0.89 (95% CI, 0.88-0.91) at PSG-RDIs of at least 5 events/h and at least 15 events/h, respectively, corresponding to positive likelihood ratios of 14.86 (95% CI, 9.86-30.12) and 5.63 (95% CI, 4.92-7.27), respectively. Conclusions and Relevance: Automatic analysis of MM patterns provided reliable performance in RDI calculation. The use of this index in OSA diagnosis appears to be promising.