Purpose: The SmartSleep Study is established to comprehensively assess the impact of night-time smartphone use on sleep patterns and health. An innovative combination of large-scale repeated survey information, high-resolution sensor-driven smartphone data, in-depth clinical examination and registry linkage allow for detailed investigations into multisystem physiological dysregulation and long-term health consequences associated with night-time smartphone use and sleep impairment. Participants: The SmartSleep Study consists of three interconnected data samples, which combined include 30,673 individuals with information on smartphone use, sleep and health. Subsamples of the study population also include high-resolution tracking data (n=5,927) collected via a customized app and deep clinical phenotypic data (n=245). A total of 7,208 participants will be followed in nationwide health registries with full data coverage and long-term follow-up. Findings to date: We highlight previous findings on the relation between smartphone use and sleep in the SmartSleep Study, and we evaluate the interventional potential of the citizen science approach used in one of the data samples. We also present new results from an analysis in which we utilize 803,000 data-points from the high-resolution tracking data to identify clusters of temporal trajectories of night-time smartphone use that characterize distinct use patterns. Based on these objective tracking data, we characterize four clusters of night-time smartphone use. Future plans: The unprecedented size and coverage of the SmartSleep Study allow for a comprehensive documentation of smartphone activity during the entire sleep span. The study will be expanded by linkage to nationwide registers, which will allow for further investigations into the long-term health and social consequences of night-time smartphone use. We also plan new rounds of data collection in the coming years.
Funding Acknowledgements Type of funding sources: Public grant(s) – EU funding. Main funding source(s): Horizon2020 Introduction Wearable devices are gaining interest in the clinical assessment of physical behavior as a marker of disease severity. With the increased use, patient willingness and adherence will be increasingly important. As part of the SafeHeart study, examining the potential of physical behavior as an identifier of clinical deterioration in patients with an implantable cardioverter defibrillator (ICD), we present preliminary results on adherence to a wrist-worn wearable used for physical behavior assessment. Purpose Define the willingness to participate and long-term adherence to wearables in an ICD population. Methods This is a preliminary analysis of the ongoing multicenter, prospective, observational SafeHeart study. SafeHeart is aimed to construct a personalized prediction engine for ICD therapy using wearable-assessed physical behavior, remote ICD monitoring, electronic health records, and patient-reported data. The study will enroll 400 participants with an ICD with or without cardiac resynchronization therapy (CRT-D). In this preliminary analysis, wearable data was analyzed for the first 50 participants, where inclusion required a minimum of 1 month of follow up data. No data from the wearables were provided to the participants. The wrist-worn wearables were used continuously (day and night) for up to 12 months of follow-up. Adherence to the wearable was measured through patient-reported (subjective) adherence and wearable-measured (objective) adherence. Data were extracted from the wearables and non-wear time was detected via open source algorithms. A valid day was set to 22 hours of available wear time with 24-hour periods assessed from 3pm to 3pm for sleep metric capture. The willingness to participate and dropout rates were calculated for the same first 50 patients of the study. Results A total of 50 ICD participants were included in this study. The mean age was 65.1 years, 82 % male, with a mean follow up of 7 weeks, generating 326 patient weeks of data. Regarding patient-reported adherence, participants reported 81.4% full adherence and 18.6 % of participants reported very brief non-wear due to e.g. sauna or surgery. Of those reporting non-wear, 62.5% described one episode only of non-wear lasting 15-75 minutes. Regarding objectively measured adherence from wearable data, full adherence was shown in 91.7% of days. The mean number of valid days per participant was 41.3. Recruitment rates showed a willingness to participate of 50% (50/100) out of eligible subjects invited. No participants were lost to follow Conclusion Results show high adherence and reasonable willingness to participate without wearable adherence dropping over time. Comparison of objectively measured and patient-reported adherence showed similar values.
Funding Acknowledgements Type of funding sources: Public grant(s) – EU funding. Main funding source(s): Eurostars Introduction Patients at a high risk of sudden cardiac death (SCD) benefit from an implantable cardioverter defibrillator (ICD). However, they remain at a high risk of (inappropriate) shocks, heart failure, mortality and psychological distress. Consumer-level wearable accelerometry as method for recording physical behaviour (PB) has gained popularity over the past years, but so far the clinical potential is largely underinvestigated. The identification of patterns in PB and the association with clinical outcomes may provide a means to improve ICD therapy. Purpose This review addresses the evidence concerning PB in ICD patients and aims to characterise PB patterns associated with clinical outcomes. Methods A systematic review of studies focussing on accelerometer-assessed PB in patients older than 18 years equipped with an ICD, or patients at a high risk of SCD (e.g. advanced heart failure) was performed. PB could be assessed using a wearable accelerometer or an embedded accelerometer in the ICD (i.e. device-measured physical activity (D-PA)). Papers presenting quantitative data in English language peer reviewed journals published between January 2000 and September 2020 were identified via the OVID MEDLINE and OVID EMBASE databases. A study protocol describing study selection, data charting and summarisation of results was developed apriori. Study selection was conducted by two independent reviewers and a third reviewer in case of disagreement. Results A total of 4219 studies were identified, of which 51 were deemed appropriate for this review. Of these studies, 29 examined D-PA (n = 169.742 patients), 19 examined wearable accelerometery (n = 1.601) and 3 validated wearable accelerometry against D-PA (n = 106). The main findings were that (i) a low level of physical activity (PA) after implantation of the ICD and (ii) a decline in physical activity were both associated with an increased risk of ICD shocks, hospitalization and mortality. Second, PB was affected by cardiac factors (e.g. onset of atrial arrhythmias, ICD shocks) and non-cardiac factors (e.g. seasonal differences, pandemic lockdown). Third, PB was related to left ventricular ejection fraction, physical and cognitive function and quality of life. The evidence regarding wearable accelerometry compared to D-PA was scarce and heterogeneous. Conclusion This review demonstrated the potential of PB as an identifier of clinical deterioration in an ICD population. Accelerometer-assessed PB data could improve early warning systems and facilitate preventive and pro-active strategies, especially considering the nature of PB as modifiable risk factor. We suggest two directions for future research: (i) prospective collection of wearable accelerometry data in an ICD population to identify the most clinically relevant behavioural metrics (ii) investigation of preventive measures that can be undertaken once changes in PB are observed. Abstract Figure. Accelerometry-derived physical behaviour
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