Fatigue and Sleep Assessment using Digital Sleep Trackers: Insights from a Multi-Device Pilot Study.

For the patient community with neurodegenerative disorders (NDD) and immune-mediated inflammatory diseases (IMID), fatigue and sleep disturbances stand out as two of the most common and disabling symptoms, which mightily impair patient's quality of life. Traditional questionnaire-oriented approaches to reflect such symptoms suffer from recall bias and poor sensitivity to change. By virtue of multiple sensing modalities at home, IDEA-FAST project aims to identify novel digital endpoints of fatigue and sleep disturbances, that are objective, reliable and sensitive to change. This article presents and discusses results from a pilot study of IDEA-FAST to evaluate the feasibility of capturing sleep and fatigue measures from three sleep trackers. Data collected from 143 participants (age range: 21-82) across 6 disease groups and healthy cohort for a period of 9 months, were investigated using our proposed sensor analytical pipeline. The overall performance reveals that the median coverage rate of sleep trackers ranged from 48.3% to 76.9%. Furthermore, the digital measures obtained from each device, indicated a higher association with sleep related patient reported outcomes (PROs) than fatigue related ones, when taking all participants into account.

Multi-Scale Evaluation of Sleep Quality Based on Motion Signal from Unobtrusive Device.

Sleep disorders are a growing threat nowadays as they are linked to neurological, cardiovascular and metabolic diseases. The gold standard methodology for sleep study is polysomnography (PSG), an intrusive and onerous technique that can disrupt normal routines. In this perspective, m-Health technologies offer an unobtrusive and rapid solution for home monitoring. We developed a multi-scale method based on motion signal extracted from an unobtrusive device to evaluate sleep behavior. Data used in this study were collected during two different acquisition campaigns by using a Pressure Bed Sensor (PBS). The first one was carried out with 22 subjects for sleep problems, and the second one comprises 11 healthy shift workers. All underwent full PSG and PBS recordings. The algorithm consists of extracting sleep quality and fragmentation indexes correlating to clinical metrics. In particular, the method classifies sleep windows of 1-s of the motion signal into: displacement (DI), quiet sleep (QS), disrupted sleep (DS) and absence from the bed (ABS). QS proved to be positively correlated (0.72±0.014) to Sleep Efficiency (SE) and DS/DI positively correlated (0.85±0.007) to the Apnea-Hypopnea Index (AHI). The work proved to be potentially helpful in the early investigation of sleep in the home environment. The minimized intrusiveness of the device together with a low complexity and good performance might provide valuable indications for the home monitoring of sleep disorders and for subjects' awareness.

Sensing gastric cancer via point-of-care sensor breath analyzer.

BACKGROUND: Detection of disease by means of volatile organic compounds from breath samples using sensors is an attractive approach to fast, noninvasive and inexpensive diagnostics. However, these techniques are still limited to applications within the laboratory settings. Here, we report on the development and use of a fast, portable, and IoT-connected point-of-care device (so-called, SniffPhone) to detect and classify gastric cancer to potentially provide new qualitative solutions for cancer screening. METHODS: A validation study of patients with gastric cancer, patients with high-risk precancerous gastric lesions, and controls was conducted with 2 SniffPhone devices. Linear discriminant analysis (LDA) was used as a classifying model of the sensing signals obatined from the examined groups. For the testing step, an additional device was added. The study group included 274 patients: 94 with gastric cancer, 67 who were in the high-risk group, and 113 controls. RESULTS: The results of the test set showed a clear discrimination between patients with gastric cancer and controls using the 2-device LDA model (area under the curve, 93.8%; sensitivity, 100%; specificity, 87.5%; overall accuracy, 91.1%), and acceptable results were also achieved for patients with high-risk lesions (the corresponding values for dysplasia were 84.9%, 45.2%, 87.5%, and 65.9%, respectively). The test-phase analysis showed lower accuracies, though still clinically useful. CONCLUSION: Our results demonstrate that a portable breath sensor device could be useful in point-of-care settings. It shows a promise for detection of gastric cancer as well as for other types of disease. LAY SUMMARY: A portable sensor-based breath analyzer for detection of gastric cancer can be used in point-of-care settings. The results are transferrable between devices via advanced IoT technology. Both the hardware and software of the reported breath analyzer could be easily modified to enable detection and monitirng of other disease states.

Vital Sign Monitoring Using FMCW Radar in Various Sleeping Scenarios.

Remote monitoring of vital signs for studying sleep is a user-friendly alternative to monitoring with sensors attached to the skin. For instance, remote monitoring can allow unconstrained movement during sleep, whereas detectors requiring a physical contact may detach and interrupt the measurement and affect sleep itself. This study evaluates the performance of a cost-effective frequency modulated continuous wave (FMCW) radar in remote monitoring of heart rate and respiration in scenarios resembling a set of normal and abnormal physiological conditions during sleep. We evaluate the vital signs of ten subjects in different lying positions during various tasks. Specifically, we aim for a broad range of both heart and respiration rates to replicate various real-life scenarios and to test the robustness of the selected vital sign extraction methods consisting of fast Fourier transform based cepstral and autocorrelation analyses. As compared to the reference signals obtained using Embla titanium, a certified medical device, we achieved an overall relative mean absolute error of 3.6% (86% correlation) and 9.1% (91% correlation) for the heart rate and respiration rate, respectively. Our results promote radar-based clinical monitoring by showing that the proposed radar technology and signal processing methods accurately capture even such alarming vital signs as minimal respiration. Furthermore, we show that common parameters for heart rate variability can also be accurately extracted from the radar signal, enabling further sleep analyses.

Multivariate Prediction of Hippocampal Atrophy in Alzheimer's Disease.

BACKGROUND: Hippocampal atrophy (HA) is one of the biomarkers for Alzheimer's disease (AD). OBJECTIVE: To identify the best biomarkers and develop models for prediction of HA over 24 months using baseline data. METHODS: The study included healthy elderly controls, subjects with mild cognitive impairment, and subjects with AD, obtained from the Alzheimer's Disease Neuroimaging Initiative (ADNI 1) and the Australian Imaging Biomarkers and Lifestyle Flagship Study of Ageing (AIBL) databases. Predictor variables included cognitive and neuropsychological tests, amyloid-ß, tau, and p-tau from cerebrospinal fluid samples, apolipoprotein E, and features extracted from magnetic resonance images (MRI). Least-mean-squares regression with elastic net regularization and least absolute deviation regression models were tested using cross-validation in ADNI 1. The generalizability of the models including only MRI features was evaluated by training the models with ADNI 1 and testing them with AIBL. The models including the full set of variables were not evaluated with AIBL because not all needed variables were available in it. RESULTS: The models including the full set of variables performed better than the models including only MRI features (root-mean-square error (RMSE) 1.76-1.82 versus 1.93-2.08). The MRI-only models performed well when applied to the independent validation cohort (RMSE 1.66-1.71). In the prediction of dichotomized HA (fast versus slow), the models achieved a reasonable prediction accuracy (0.79-0.87). CONCLUSIONS: These models can potentially help identifying subjects predicted to have a faster HA rate. This can help in selection of suitable patients into clinical trials testing disease-modifying drugs for AD.

Development of a Non-invasive Device for Swallow Screening in Patients at Risk of Oropharyngeal Dysphagia: Results from a Prospective Exploratory Study.

Oropharyngeal dysphagia is prevalent in several at-risk populations, including post-stroke patients, patients in intensive care and the elderly. Dysphagia contributes to longer hospital stays and poor outcomes, including pneumonia. Early identification of dysphagia is recommended as part of the evaluation of at-risk patients, but available bedside screening tools perform inconsistently. In this study, we developed algorithms to detect swallowing impairment using a novel accelerometer-based dysphagia detection system (DDS). A sample of 344 individuals was enrolled across seven sites in the United States. Dual-axis accelerometry signals were collected prospectively with simultaneous videofluoroscopy (VFSS) during swallows of liquid barium stimuli in thin, mildly, moderately and extremely thick consistencies. Signal processing classifiers were trained using linear discriminant analysis and 10,000 random training-test data splits. The primary objective was to develop an algorithm to detect impaired swallowing safety with thin liquids with an area under receiver operating characteristic curve (AUC) > 80% compared to the VFSS reference standard. Impaired swallowing safety was identified in 7.2% of the thin liquid boluses collected. At least one unsafe thin liquid bolus was found in 19.7% of participants, but participants did not exhibit impaired safety consistently. The DDS classifier algorithms identified participants with impaired thin liquid swallowing safety with a mean AUC of 81.5%, (sensitivity 90.4%, specificity 60.0%). Thicker consistencies were effective for reducing the frequency of penetration-aspiration. This DDS reached targeted performance goals in detecting impaired swallowing safety with thin liquids. Simultaneous measures by DDS and VFSS, as performed here, will be used for future validation studies.

Improvement of force-sensor-based heart rate estimation using multichannel data fusion.

The aim of this paper is to present and evaluate algorithms for heartbeat interval estimation from multiple spatially distributed force sensors integrated into a bed. Moreover, the benefit of using multichannel systems as opposed to a single sensor is investigated. While it might seem intuitive that multiple channels are superior to a single channel, the main challenge lies in finding suitable methods to actually leverage this potential. To this end, two algorithms for heart rate estimation from multichannel vibration signals are presented and compared against a single-channel sensing solution. The first method operates by analyzing the cepstrum computed from the average spectra of the individual channels, while the second method applies Bayesian fusion to three interval estimators, such as the autocorrelation, which are applied to each channel. This evaluation is based on 28 night-long sleep lab recordings during which an eight-channel polyvinylidene fluoride-based sensor array was used to acquire cardiac vibration signals. The recruited patients suffered from different sleep disorders of varying severity. From the sensor array data, a virtual single-channel signal was also derived for comparison by averaging the channels. The single-channel results achieved a beat-to-beat interval error of 2.2% with a coverage (i.e., percentage of the recording which could be analyzed) of 68.7%. In comparison, the best multichannel results attained a mean error and coverage of 1.0% and 81.0%, respectively. These results present statistically significant improvements of both metrics over the single-channel results (p < 0.05).

Detection of sleep-disordered breating with Pressure Bed Sensor.

A Pressure Bed Sensor (PBS) can offer an unobtrusive method for sleep monitoring. This study focuses on the detection of the sleep related breathing disorders using a PBS in comparison to the methods used in a sleep laboratory. A newly developed PCA modeling approach for the eight sensor signals of the PBS is evaluated using the Reduced Respiratory Amplitude Index (RRAI) as a central measure. The method computes the respiration amplitude with the Hilbert transform, and then detects the events based on a 20% amplitude reduction from the baseline signal. A similar calculation was used for the sleep laboratory RIP measurements, and both PBS and RIP were compared against the reference based on the nasal flow signal. In the reference RRAI method, the respiratory-disordered events were obtained using RemLogic respiration analyzer to detect over 50% amplitude reduction in the nasal respiratory flow, but removing the RemLogic standard hypopnea event associations on the oxygen desaturation events and the sleep arousals. The movement artifacts were automatically detected based on the movement activity signal of the PBS. Twenty-five (25) out of 28 patients were finally analysed. On average 87% of a night measurement has been covered by the system. The correlation coefficient was 0.92 between the PBS and the reference RRAI, and the performance of the PBS was similar with the RIP belts. Classifying the severity of the sleep related breathing by dividing RRAI in groups according to the severity criteria, the sensitivity was 92% and the specificity was 70% for the PBS. The results suggest that PBS recording can provide an easy and un-obstructive alternative method for the detection of the sleep disordered breathing and thus has a great promise for the home monitoring.

Evaluation of the sleep quality based on bed sensor signals: Time-variant analysis.

Automatic detection of the sleep macrostructure (Wake, NREM -non Rapid Eye Movement- and REM -Rapid Eye Movement-) based on bed sensor signals is presented. This study assesses the feasibility of different methodologies to evaluate the sleep quality out of sleep centers. The study compares a) the features extracted from time-variant autoregressive modeling (TVAM) and Wavelet Decomposition (WD) and b) the performance of K-Nearest Neighbor (KNN) and Feed Forward Neural Networks (FFNN) classifiers. In the current analysis, 17 full polysomnography recordings from healthy subjects were used. The best agreement for Wake-NREM-REM with respect to the gold standard was 71.95 ± 7.47% of accuracy and 0.42 ± 0.10 of kappa index for TVAM-LD while WD-FFNN shows 67.17 ± 11.88% of accuracy and 0.39 ± 0.13 of kappa index. The results suggest that the sleep quality assessment out of sleep centers could be possible and as consequence more people could be beneficiated.

Sleep staging based on signals acquired through bed sensor.

We describe a system for the evaluation of the sleep macrostructure on the basis of Emfit sensor foils placed into bed mattress and of advanced signal processing. The signals on which the analysis is based are heart-beat interval (HBI) and movement activity obtained from the bed sensor, the relevant features and parameters obtained through a time-variant autoregressive model (TVAM) used as feature extractor, and the classification obtained through a hidden Markov model (HMM). Parameters coming from the joint probability of the HBI features were used as input to a HMM, while movement features are used for wake period detection. A total of 18 recordings from healthy subjects, including also reference polysomnography, were used for the validation of the system. When compared to wake-nonrapid-eye-movement (NREM)-REM classification provided by experts, the described system achieved a total accuracy of 79+/-9% and a kappa index of 0.43+/-0.17 with only two HBI features and one movement parameter, and a total accuracy of 79+/-10% and a kappa index of 0.44+/-0.19 with three HBI features and one movement parameter. These results suggest that the combination of HBI and movement features could be a suitable alternative for sleep staging with the advantage of low cost and simplicity.

Automatic detection of sleep macrostructure based on bed sensors.

This study analyses the spectral components of the heart rate fluctuations of a new contact-less technology for sleep evaluation. Both heart beat interval (HBI) and movement activity were extracted from the multichannel ballistocardiographic (BCG) measurements, based on Emfit sensor foils placed into bed mattress. Powers spectral densities (PSD) of HBI have been compared with the ones obtained from the standard ECG during sleep stage 2. In addition, spectral features obtained from the contact-less technology and standard ECG has been used to automatically classify the sleep macrostructure through a time-varying autoregressive model and a Hidden Markov Model. Whole night recordings from six subjects were analyzed in this study. Spectral components did not show significant differences between the two measurements. Further, contactless technology achieved a total accuracy of 83 % and kappa index of 0.42, while standard ECG achieved an accuracy of 84 % and kappa index of 0.43 when compared to clinical sleep staging from polysomnography.

FFT averaging of multichannel BCG signals from bed mattress sensor to improve estimation of heart beat interval.

A multichannel pressure sensing Emfit foil was integrated to a bed mattress for measuring ballistocardiograph signals during sleep. We calculated the heart beat interval with cepstrum method, by applying FFT for short time windows including pair of consequent heart beats. We decreased the variance of FFT by averaging the multichannel data in the frequency domain. Relative error of our method in reference to electrocardiograph RR interval was only 0.35% for 15 night recordings with six normal subjects, when 12% of data was automatically removed due to movement artifacts. Background motivation for this work is given from the studies applying heart rate variability for the sleep staging.