A Protocol for Evaluating Digital Technology for Monitoring Sleep and Circadian Rhythms in Older People and People Living with Dementia in the Community.

Sleep and circadian rhythm disturbance are predictors of poor physical and mental health, including dementia. Long-term digital technology-enabled monitoring of sleep and circadian rhythms in the community has great potential for early diagnosis, monitoring of disease progression, and assessing the effectiveness of interventions. Before novel digital technology-based monitoring can be implemented at scale, its performance and acceptability need to be evaluated and compared to gold-standard methodology in relevant populations. Here, we describe our protocol for the evaluation of novel sleep and circadian technology which we have applied in cognitively intact older adults and are currently using in people living with dementia (PLWD). In this protocol, we test a range of technologies simultaneously at home (7-14 days) and subsequently in a clinical research facility in which gold standard methodology for assessing sleep and circadian physiology is implemented. We emphasize the importance of assessing both nocturnal and diurnal sleep (naps), valid markers of circadian physiology, and that evaluation of technology is best achieved in protocols in which sleep is mildly disturbed and in populations that are relevant to the intended use-case. We provide details on the design, implementation, challenges, and advantages of this protocol, along with examples of datasets.

Correction: Three Contactless Sleep Technologies Compared With Actigraphy and Polysomnography in a Heterogeneous Group of Older Men and Women in a Model of Mild Sleep Disturbance: Sleep Laboratory Study.

[This corrects the article DOI: 10.2196/46338.].

Three Contactless Sleep Technologies Compared With Actigraphy and Polysomnography in a Heterogeneous Group of Older Men and Women in a Model of Mild Sleep Disturbance: Sleep Laboratory Study.

BACKGROUND: Contactless sleep technologies (CSTs) hold promise for longitudinal, unobtrusive sleep monitoring in the community and at scale. They may be particularly useful in older populations wherein sleep disturbance, which may be indicative of the deterioration of physical and mental health, is highly prevalent. However, few CSTs have been evaluated in older people. OBJECTIVE: This study evaluated the performance of 3 CSTs compared to polysomnography (PSG) and actigraphy in an older population. METHODS: Overall, 35 older men and women (age: mean 70.8, SD 4.9 y; women: n=14, 40%), several of whom had comorbidities, including sleep apnea, participated in the study. Sleep was recorded simultaneously using a bedside radar (Somnofy [Vital Things]: n=17), 2 undermattress devices (Withings sleep analyzer [WSA; Withings Inc]: n=35; Emfit-QS [Emfit; Emfit Ltd]: n=17), PSG (n=35), and actigraphy (Actiwatch Spectrum [Philips Respironics]: n=18) during the first night in a 10-hour time-in-bed protocol conducted in a sleep laboratory. The devices were evaluated through performance metrics for summary measures and epoch-by-epoch classification. PSG served as the gold standard. RESULTS: The protocol induced mild sleep disturbance with a mean sleep efficiency (SEFF) of 70.9% (SD 10.4%; range 52.27%-92.60%). All 3 CSTs overestimated the total sleep time (TST; bias: >90 min) and SEFF (bias: >13%) and underestimated wake after sleep onset (bias: >50 min). Sleep onset latency was accurately detected by the bedside radar (bias: <6 min) but overestimated by the undermattress devices (bias: >16 min). CSTs did not perform as well as actigraphy in estimating the all-night sleep summary measures. In an epoch-by-epoch concordance analysis, the bedside radar performed better in discriminating sleep versus wake (Matthew correlation coefficient [MCC]: mean 0.63, SD 0.12, 95% CI 0.57-0.69) than the undermattress devices (MCC of WSA: mean 0.41, SD 0.15, 95% CI 0.36-0.46; MCC of Emfit: mean 0.35, SD 0.16, 95% CI 0.26-0.43). The accuracy of identifying rapid eye movement and light sleep was poor across all CSTs, whereas deep sleep (ie, slow wave sleep) was predicted with moderate accuracy (MCC: >0.45) by both Somnofy and WSA. The deep sleep duration estimates of Somnofy correlated (r2=0.60; P<.01) with electroencephalography slow wave activity (0.75-4.5 Hz) derived from PSG, whereas for the undermattress devices, this correlation was not significant (WSA: r2=0.0096, P=.58; Emfit: r2=0.11, P=.21). CONCLUSIONS: These CSTs overestimated the TST, and sleep stage prediction was unsatisfactory in this group of older people in whom SEFF was relatively low. Although it was previously shown that CSTs provide useful information on bed occupancy, which may be useful for particular use cases, the performance of these CSTs with respect to the TST and sleep stage estimation requires improvement before they can serve as an alternative to PSG in estimating most sleep variables in older individuals.

Multicohort cross-sectional study of cognitive and behavioural digital biomarkers in neurodegeneration: the Living Lab Study protocol.

INTRODUCTION AND AIMS: Digital biomarkers can provide a cost-effective, objective and robust measure for neurological disease progression, changes in care needs and the effect of interventions. Motor function, physiology and behaviour can provide informative measures of neurological conditions and neurodegenerative decline. New digital technologies present an opportunity to provide remote, high-frequency monitoring of patients from within their homes. The purpose of the living lab study is to develop novel digital biomarkers of functional impairment in those living with neurodegenerative disease (NDD) and neurological conditions. METHODS AND ANALYSIS: The Living Lab study is a cross-sectional observational study of cognition and behaviour in people living with NDDs and other, non-degenerative neurological conditions. Patients (n≥25 for each patient group) with dementia, Parkinson's disease, amyotrophic lateral sclerosis, mild cognitive impairment, traumatic brain injury and stroke along with controls (n≥60) will be pragmatically recruited. Patients will carry out activities of daily living and functional assessments within the Living Lab. The Living Lab is an apartment-laboratory containing a functional kitchen, bathroom, bed and living area to provide a controlled environment to develop novel digital biomarkers. The Living Lab provides an important intermediary stage between the conventional laboratory and the home. Multiple passive environmental sensors, internet-enabled medical devices, wearables and electroencephalography (EEG) will be used to characterise functional impairments of NDDs and non-NDD conditions. We will also relate these digital technology measures to clinical and cognitive outcomes. ETHICS AND DISSEMINATION: Ethical approvals have been granted by the Imperial College Research Ethics Committee (reference number: 21IC6992). Results from the study will be disseminated at conferences and within peer-reviewed journals.

Contactless and longitudinal monitoring of nocturnal sleep and daytime naps in older men and women: a digital health technology evaluation study.

STUDY OBJECTIVES: To compare the 24-hour sleep assessment capabilities of two contactless sleep technologies (CSTs) to actigraphy in community-dwelling older adults. METHODS: We collected 7-14 days of data at home from 35 older adults (age: 65-83), some with medical conditions, using Withings Sleep Analyser (WSA, n = 29), Emfit QS (Emfit, n = 17), a standard actigraphy device (Actiwatch Spectrum [AWS, n = 34]), and a sleep diary (n = 35). We compared nocturnal and daytime sleep measures estimated by the CSTs and actigraphy without sleep diary information (AWS-A) against sleep-diary-assisted actigraphy (AWS|SD). RESULTS: Compared to sleep diary, both CSTs accurately determined the timing of nocturnal sleep (intraclass correlation [ICC]: going to bed, getting out of bed, time in bed >0.75), whereas the accuracy of AWS-A was much lower. Compared to AWS|SD, the CSTs overestimated nocturnal total sleep time (WSA: +92.71 ± 81.16 minutes; Emfit: +101.47 ± 75.95 minutes) as did AWS-A (+46.95 ± 67.26 minutes). The CSTs overestimated sleep efficiency (WSA: +9.19% ± 14.26%; Emfit: +9.41% ± 11.05%), whereas AWS-A estimate (-2.38% ± 10.06%) was accurate. About 65% (n = 23) of participants reported daytime naps either in bed or elsewhere. About 90% in-bed nap periods were accurately determined by WSA while Emfit was less accurate. All three devices estimated 24-hour sleep duration with an error of ≈10% compared to the sleep diary. CONCLUSIONS: CSTs accurately capture the timing of in-bed nocturnal sleep periods without the need for sleep diary information. However, improvements are needed in assessing parameters such as total sleep time, sleep efficiency, and naps before these CSTs can be fully utilized in field settings.

Evaluating the Empatica E4 Derived Heart Rate and Heart Rate Variability Measures in Older Men and Women.

Wearable heart rate monitors offer a cost-effective way of non-invasive, long-term monitoring of cardiac health. Validation of wearable technologies in an older populations is essential for evaluating their effectiveness during deployment in healthcare settings. To this end, we evaluated the validity of heart rate measures from a wearable device, Empatica E4, and compared them to the electrocardiography (ECG). We collected E4 data simultaneously with ECG in thirty-five older men and women during an overnight sleep recording in the laboratory. We propose a robust approach to resolve the missing inter-beat interval (IBI) data and improve the quality of E4 derived measures. We also evaluated the concordance of heart rate (HR) and heart rate variability (HRV) measures with ECG. The results demonstrate that the automatic E4 heart rate measures capture long-term HRV whilst the short-term metrics are affected by missing IBIs. Our approach provides an effective way to resolve the missing IBI issue of E4 and extracts reliable heart rate measures that are concordant with ECG. Clinical Relevance- This work discusses data quality challenges in heart rate data acquired by wearables and provides an efficient and reliable approach for extracting heart rate measures from the E4 wearable device and validates the metrics in older adults.