Protocol of the SOMNIA project : an observational study to create a neurophysiological database for advanced clinical sleep monitoring

Introduction Polysomnography (PSG) is the primary tool for sleep monitoring and the diagnosis of sleep disorders. Recent advances in signal analysis make it possible to reveal more information from this rich data source. Furthermore, many innovative sleep monitoring techniques are being developed that are less obtrusive, easier to use over long time periods and in the home situation. Here, we describe the methods of the Sleep and Obstructive Sleep Apnoea Monitoring with Non-Invasive Applications (SOMNIA) project, yielding a database combining clinical PSG with advanced unobtrusive sleep monitoring modalities in a large cohort of patients with various sleep disorders. The SOMNIA database will facilitate the validation and assessment of the diagnostic value of the new techniques, as well as the development of additional indices and biomarkers derived from new and/or traditional sleep monitoring methods. Methods and analysis We aim to include at least 2100 subjects (both adults and children) with a variety of sleep disorders who undergo a PSG as part of standard clinical care in a dedicated sleep centre. Full-video PSG will be performed according to the standards of the American Academy of Sleep Medicine. Each recording will be supplemented with one or more new monitoring systems, including wrist-worn photoplethysmography and actigraphy, pressure sensing mattresses, multimicrophone recording of respiratory sounds including snoring, suprasternal pressure monitoring and multielectrode electromyography of the diaphragm

The 2023 wearable photoplethysmography roadmap

Photoplethysmography is a key sensing technology which is used in wearable devices such as smartwatches and fitness trackers. Currently, photoplethysmography sensors are used to monitor physiological parameters including heart rate and heart rhythm, and to track activities like sleep and exercise. Yet, wearable photoplethysmography has potential to provide much more information on health and wellbeing, which could inform clinical decision making. This Roadmap outlines directions for research and development to realise the full potential of wearable photoplethysmography. Experts discuss key topics within the areas of sensor design, signal processing, clinical applications, and research directions. Their perspectives provide valuable guidance to researchers developing wearable photoplethysmography technology

Verification, Analytical Validation, and Clinical Validation (V3): The Foundation of Determining Fit-for-Purpose for Biometric Monitoring Technologies (BioMeTs)

Digital medicine is an interdisciplinary field, drawing together stakeholders with expertize in engineering, manufacturing, clinical science, data science, biostatistics, regulatory science, ethics, patient advocacy, and healthcare policy, to name a few. Although this diversity is undoubtedly valuable, it can lead to confusion regarding terminology and best practices. There are many instances, as we detail in this paper, where a single term is used by different groups to mean different things, as well as cases where multiple terms are used to describe essentially the same concept. Our intent is to clarify core terminology and best practices for the evaluation of Biometric Monitoring Technologies (BioMeTs), without unnecessarily introducing new terms. We focus on the evaluation of BioMeTs as fit-for-purpose for use in clinical trials. However, our intent is for this framework to be instructional to all users of digital measurement tools, regardless of setting or intended use. We propose and describe a three-component framework intended to provide a foundational evaluation framework for BioMeTs. This framework includes (1) verification, (2) analytical validation, and (3) clinical validation. We aim for this common vocabulary to enable more effective communication and collaboration, generate a common and meaningful evidence base for BioMeTs, and improve the accessibility of the digital medicine field

a critical review

The availability of wearable devices (WDs) to collect biometric information and their use during activities of daily living is significantly increasing in the general population. These small electronic devices, which record fitness and health-related outcomes, have been broadly utilized in industries such as medicine, healthcare, and fitness. Since they are simple to use and progressively cheaper, they have also been used for numerous research purposes. However, despite their increasing popularity, most of these WDs do not accurately measure the proclaimed outcomes. In fact, research is equivocal about whether they are valid and reliable methods to specifically evaluate physical activity and health-related outcomes in older adults, since they are mostly designed and produced considering younger subjects? physical and mental characteristics. Additionally, their constant evolution through continuous upgrades and redesigned versions, suggests the need for constant up-to-date reviews and research. Accordingly, this article aims to scrutinize the state-of-the-art scientific evidence about the usefulness of WDs, specifically on older adults, to monitor physical activity and health-related outcomes. This critical review not only aims to inform older consumers but also aid researchers in study design when selecting physical activity and healthcare monitoring devices for elderly people.DB19-D819-F720 | Carlos Eduardo da Silva TeixeiraN/

Cuffless Blood Pressure in clinical practice: challenges, opportunities and current limits.

Background: Cuffless blood pressure measurement technologies have attracted significant attention for their potential to transform cardiovascular monitoring.Methods: This updated narrative review thoroughly examines the challenges, opportunities, and limitations associated with the implementation of cuffless blood pressure monitoring systems.Results: Diverse technologies, including photoplethysmography, tonometry, and ECG analysis, enable cuffless blood pressure measurement and are integrated into devices like smartphones and smartwatches. Signal processing emerges as a critical aspect, dictating the accuracy and reliability of readings. Despite its potential, the integration of cuffless technologies into clinical practice faces obstacles, including the need to address concerns related to accuracy, calibration, and standardization across diverse devices and patient populations. The development of robust algorithms to mitigate artifacts and environmental disturbances is essential for extracting clear physiological signals. Based on extensive research, this review emphasizes the necessity for standardized protocols, validation studies, and regulatory frameworks to ensure the reliability and safety of cuffless blood pressure monitoring devices and their implementation in mainstream medical practice. Interdisciplinary collaborations between engineers, clinicians, and regulatory bodies are crucial to address technical, clinical, and regulatory complexities during implementation. In conclusion, while cuffless blood pressure monitoring holds immense potential to transform cardiovascular care. The resolution of existing challenges and the establishment of rigorous standards are imperative for its seamless incorporation into routine clinical practice.Conclusion: The emergence of these new technologies shifts the paradigm of cardiovascular health management, presenting a new possibility for non-invasive continuous and dynamic monitoring. The concept of cuffless blood pressure measurement is viable and more finely tuned devices are expected to enter the market, which could redefine our understanding of blood pressure and hypertension

Acoustic sensing as a novel approach for cardiovascular monitoring at the wrist

Cardiovascular diseases are the number one cause of deaths globally. An increased cardiovascular risk can be detected by a regular monitoring of the vital signs including the heart rate, the heart rate variability (HRV) and the blood pressure. For a user to undergo continuous vital sign monitoring, wearable systems prove to be very useful as the device can be integrated into the user's lifestyle without affecting the daily activities. However, the main challenge associated with the monitoring of these cardiovascular parameters is the requirement of different sensing mechanisms at different measurement sites. There is not a single wearable device that can provide sufficient physiological information to track the vital signs from a single site on the body. This thesis proposes a novel concept of using acoustic sensing over the radial artery to extract cardiac parameters for vital sign monitoring. A wearable system consisting of a microphone is designed to allow the detection of the heart sounds together with the pulse wave, an attribute not possible with existing wrist-based sensing methods. Methods: The acoustic signals recorded from the radial artery are a continuous reflection of the instantaneous cardiac activity. These signals are studied and characterised using different algorithms to extract cardiovascular parameters. The validity of the proposed principle is firstly demonstrated using a novel algorithm to extract the heart rate from these signals. The algorithm utilises the power spectral analysis of the acoustic pulse signal to detect the S1 sounds and additionally, the K-means method to remove motion artifacts for an accurate heartbeat detection. The HRV in the short-term acoustic recordings is found by extracting the S1 events using the relative information between the short- and long-term energies of the signal. The S1 events are localised using three different characteristic points and the best representation is found by comparing the instantaneous heart rate profiles. The possibility of measuring the blood pressure using the wearable device is shown by recording the acoustic signal under the influence of external pressure applied on the arterial branch. The temporal and spectral characteristics of the acoustic signal are utilised to extract the feature signals and obtain a relationship with the systolic blood pressure (SBP) and diastolic blood pressure (DBP) respectively. Results: This thesis proposes three different algorithms to find the heart rate, the HRV and the SBP/ DBP readings from the acoustic signals recorded at the wrist. The results obtained by each algorithm are as follows: 1. The heart rate algorithm is validated on a dataset consisting of 12 subjects with a data length of 6 hours. The results demonstrate an accuracy of 98.78%, mean absolute error of 0.28 bpm, limits of agreement between -1.68 and 1.69 bpm, and a correlation coefficient of 0.998 with reference to a state-of-the-art PPG-based commercial device. A high statistical agreement between the heart rate obtained from the acoustic signal and the photoplethysmography (PPG) signal is observed. 2. The HRV algorithm is validated on the short-term acoustic signals of 5-minutes duration recorded from each of the 12 subjects. A comparison is established with the simultaneously recorded electrocardiography (ECG) and PPG signals respectively. The instantaneous heart rate for all the subjects combined together achieves an accuracy of 98.50% and 98.96% with respect to the ECG and PPG signals respectively. The results for the time-domain and frequency-domain HRV parameters also demonstrate high statistical agreement with the ECG and PPG signals respectively. 3. The algorithm proposed for the SBP/ DBP determination is validated on 104 acoustic signals recorded from 40 adult subjects. The experimental outputs when compared with the reference arm- and wrist-based monitors produce a mean error of less than 2 mmHg and a standard deviation of error around 6 mmHg. Based on these results, this thesis shows the potential of this new sensing modality to be used as an alternative, or to complement existing methods, for the continuous monitoring of heart rate and HRV, and spot measurement of the blood pressure at the wrist.Open Acces

Wearable technology and the cardiovascular system: the future of patient assessment

The past decade has seen a dramatic rise in consumer technologies able to monitor a variety of cardiovascular parameters. Such devices initially recorded markers of exercise, but now include physiological and health-care focused measurements. The public are keen to adopt these devices in the belief that they are useful to identify and monitor cardiovascular disease. Clinicians are therefore often presented with health app data accompanied by a diverse range of concerns and queries. Herein, we assess whether these devices are accurate, their outputs validated, and whether they are suitable for professionals to make management decisions. We review underpinning methods and technologies and explore the evidence supporting the use of these devices as diagnostic and monitoring tools in hypertension, arrhythmia, heart failure, coronary artery disease, pulmonary hypertension, and valvular heart disease. Used correctly, they might improve health care and support research

Continuous physical activity recording - Consumer-based activity trackers in epidemiological studies

Physical activity is an important modifiable lifestyle factor that can improve general health and reduce the risk of disease. Currently, collecting data on physical activity in epidemiological studies are generally limited to long-term but self-reported and inaccurate physical activity questionnaires and/or using short-term but objective and more accurate accelerometers. Consumer-based activity trackers are designed for long-term objective data collection and can therefore potentially be used to close this gap. The objective of this dissertation was therefore to explore and develop new methods for collecting data on physical activity in epidemiological studies using consumer-based activity trackers. The four included papers apply different methods to explore the objective from multiple angles. Results includes an overview of how activity tracker sensor support has changed over time, recommendations when choosing an activity tracker model for future physical activity research, recommendations for increasing activity tracker wear time among participants in clinical studies, as well as knowledge about activity tracker validity and physical activity trends during the Norwegian COVID-19 lockdown in 2020. Finally, the dissertation describes a system for automatic and continuous data collection using consumer-based activity trackers from multiple providers. We show the usability of this system by accessing and analysing historic activity tracker data from participants who wore a tracker before-, during-, and after the COVID-19 lockdown period. The proposed system can be a valuable addition to existing methods for physical activity assessment by contributing to closing the above-mentioned method gap

Assessment of Physical Activity in Adults with Progressive Muscle Disease

Introduction: Insufficient physical activity is a major threat to global health. Physical activity benefits peoples’ physical and mental health. The general population, including people living with disabilities and muscle wasting conditions, are recommended to avoid excessive sedentary time and engage in daily activity. Adults with progressive muscle disease experience barriers to physical activity participation, including muscle weakness, fatigue, physical deconditioning, impairment, activity limitations and participation restrictions (including societal and environmental factors), and fear of symptom exacerbation. More research is required to understand the inter-relationship between health and physical activity for adults with progressive muscle disease, particularly non-ambulant people who are under-represented in the existing research literature. Accurate measurement of FITT (frequency, intensity, time, and type of physical activity) is vital for high-quality physical activity assessment. The aim of this thesis was to assess the physical activity of ambulant and non-ambulant adults with progressive muscle disease.Systematic review findings identified various measures used to assess physical activity in adults with muscular dystrophy, including accelerometers, direct observation, heart rate monitors, calorimetry, positioning systems, activity diaries, single scales, interviews and questionnaires. None of the measures identified in the systematic review had well established measurement properties for adults with muscular dystrophy.Patient and public involvement interviews highlighted the importance of inclusive, remote, and technology-facilitated research design, the potential intrusion of direct observations of physical activity, the familiarity of questionnaires for data collection, and practical considerations to ensure wearing an activity monitor was not too burdensome.A feasibility study using multiple methods in 20 ambulant and non-ambulant adults with progressive muscle disease revealed satisfactory acceptability, interpretability, and usability of Fitbit and activity questionnaires, in both paper and electronic formats. During supervised activity tasks, Fitbit was found to have satisfactory criterion validity, reliability, and responsiveness and measurement properties were strengthened using multisensory measurement.An observational, longitudinal study that included 111 ambulant and non-ambulant adults with progressive muscle disease showed that:Activity monitoring had satisfactory validity, reliability and responsiveness using Fitbit, but there was considerable measurement error between Fitbit and the research grade GENEActiv accelerometer. Fitbit thresholds and multiple metrics (including accelerometer and heart rate data extrapolations of FITT) were appropriate for physical activity assessment in ambulant and non-ambulant adults with progressive muscle disease.Activity self-report had unsatisfactory concurrent validity, test-retest reliability, and responsiveness with substantial activity overestimation using the modified International Physical Activity Questionnaire. However, self-report properties were improved when used concurrently with Fitbit.Observed physical activity in adults with progressive muscle disease was generally low with excessive daily sedentary time. Activity frequencies, intensities and durations were lower, and activity types were more domestic, for wheelchair users and during the COVID-19 lockdown. Lower physical activity was significantly associated with greater functional impairment, less cardiorespiratory fitness, worse metabolic health, and lower quality of life. Activity optimisation thresholds and minimal clinically important differences were established.Discussion: The implications of this thesis include guidance for selection of appropriate physical activity measures by clinicians and researchers working with adults with progressive muscle disease. Fitbit is suitable in clinical practice and research for interactive, weekly remote activity monitoring or to support activity self-management and may represent an appropriate compromise between potential underestimation by accelerometry alone, and overestimation by self-report alone. A draft conceptual framework for physical activity measurement was also proposed. It includes frequency, intensity, time, and type of physical activity, and incorporates wider aspects of the physical activity construct, including somatic factors (relating to progressive muscle disease and underlying fitness) and contextual factors (relating to personal, social, and environmental situations). Future research will build on the knowledge gained in this thesis, furthering understanding of the inter-relationships between physical activity, health and wider contexts. Implementation will include testing a remote physical activity optimisation intervention that is inclusive of ambulant and non-ambulant participants, featuring Fitbit self-monitoring with a focus on optimisation of daily activity frequency and regularly interrupting sedentary time.</div