Validation of a new wearable device for type 3 sleep test without flowmeter.
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ABSTRACT: Background
Ventilation monitoring during sleep is performed by sleep test instrumentation that is uncomfortable for the patients due to the presence of the flowmeter. The objective of this study was to evaluate if an innovative type 3 wearable system, the X10X and X10Y, is able to correctly detect events of apnea and hypopnea and to classify the severity of sleep apnea without the use of a flowmeter.Methods
40 patients with sleep disordered breathing were analyzed by continuous and simultaneous recording of X10X and X10Y and another certified type 3 system, SOMNOtouch, used for comparison. Evaluation was performed in terms of quality of respiratory signals (scores from 1, lowest, to 5, highest), duration and classification of apneas, as well as identification and duration of hypopneas.Results
580 periods were evaluated. Mean quality assigned score was 3.37±1.42 and 3.25±1.35 for X10X and X10Y and SOMNOtouch, respectively. The agreement between the two systems was evaluated with grades 4 and 5 in 383 out of 580 cases. A high correlation (r2 = 0.921; p<0.001) was found between the AHI indexes obtained from the two systems. X10X and X10Y devices were able to correctly classify 72.3% of the obstructive apneas, 81% of the central apneas, 61.3% of the hypopneas, and 64.6% of the mixed apneas when compared to SOMNOtouch device.Conclusion
The X10X and X10Y devices are able to provide a correct grading of sleep respiratory disorders without the need of a nasal cannula for respiratory flow measurement and can be considered as a type 3 sleep test device for screening tests.
SUBMITTER: Contini M
PROVIDER: S-EPMC8051765 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:Study objectivesTo compare the quality and consistency in sleep measurement of a consumer wearable device and a research-grade actigraph with polysomnography (PSG) in adolescents.MethodsFifty-eight healthy adolescents (aged 15-19 years; 30 males) underwent overnight PSG while wearing both a Fitbit Alta HR and a Philips Respironics Actiwatch 2 (AW2) for 5 nights, with either 5 hours or 6.5 hours time in bed (TIB) and for 4 nights with 9 hours TIB. AW2 data were evaluated using two different wake and immobility thresholds. Discrepancies in estimated total sleep time (TST) and wake after sleep onset (WASO) between devices and PSG, as well as epoch-by-epoch agreements in sleep/wake classification, were assessed. Fitbit-generated sleep staging was compared to PSG.ResultsFitbit and AW2 under default settings similarly underestimated TST and overestimated WASO (TST: medium setting (M10) ≤ 38 minutes, Fitbit ≤ 47 minutes; WASO: M10 ≤ 38 minutes; Fitbit ≤ 42 minutes). AW2 at the high motion threshold setting provided readings closest to PSG (TST: ≤ 12 minutes; WASO: ≤ 18 minutes). Sensitivity for detecting sleep was ≥ 90% for both wearable devices and further improved to 95% by using the high threshold (H5) setting for the AW2 (0.95). Wake detection specificity was highest in Fitbit (≥ 0.88), followed by the AW2 at M10 (≥ 0.80) and H5 thresholds (≤ 0.73). In addition, Fitbit inconsistently estimated stage N1 + N2 sleep depending on TIB, underestimated stage N3 sleep (21-46 min), but was comparable to PSG for rapid eye movement sleep. Fitbit sensitivity values for the detection of N1 + N2, N3 and rapid eye movement sleep were ≥ 0.68, ≥ 0.50, and ≥ 0.72, respectively.ConclusionsA consumer-grade wearable device can measure sleep duration as well as a research actigraph. However, sleep staging would benefit from further refinement before these methods can be reliably used for adolescents.Clinical trial registrationRegistry: ClinicalTrials.gov; Title: The Cognitive and Metabolic Effects of Sleep Restriction in Adolescents; Identifier: NCT03333512; URL: https://clinicaltrials.gov/ct2/show/NCT03333512.CitationLee XK, Chee NIYN, Ong JL, Teo TB, van Rijn E, Lo JC, Chee MWL. Validation of a consumer sleep wearable device with actigraphy and polysomnography in adolescents across sleep opportunity manipulations. J Clin Sleep Med. 2019;15(9):1337-1346.
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Project description:BACKGROUND:The proliferation of wearable devices that collect activity and heart rate data has facilitated new ways to measure sleeping and waking durations unobtrusively and longitudinally. Most existing sleep/wake identification algorithms are based on activity only and are trained on expensive and laboriously annotated polysomnography (PSG). Heart rate can also be reflective of sleep/wake transitions, which has motivated its investigation herein in an unsupervised algorithm. Moreover, it is necessary to develop a personalized approach to deal with interindividual variance in sleep/wake patterns. OBJECTIVE:We aimed to develop an unsupervised personalized sleep/wake identification algorithm using multifaceted data to explore the benefits of incorporating both heart rate and activity level in these types of algorithms and to compare this approach's output with that of an existing commercial wearable device's algorithms. METHODS:In this study, a total of 14 community-dwelling older adults wore wearable devices (Fitbit Alta; Fitbit Inc) 24 hours a day and 7 days a week over period of 3 months during which their heart rate and activity data were collected. After preprocessing the data, a model was developed to distinguish sleep/wake states based on each individual's data. We proposed the use of hidden Markov models and compared different modeling schemes. With the best model selected, sleep/wake patterns were characterized by estimated parameters in hidden Markov models, and sleep/wake states were identified. RESULTS:When applying our proposed algorithm on a daily basis, we found there were significant differences in estimated parameters between weekday models and weekend models for some participants. CONCLUSIONS:Our unsupervised approach can be effectively implemented based on an individual's multifaceted sleep-related data from a commercial wearable device. A personalized model is shown to be necessary given the interindividual variability in estimated parameters.
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Project description:BackgroundActigraphs are wrist-worn devices that record tri-axial accelerometry data used clinically and in research studies. The expense of research-grade actigraphs, however, limit their widespread adoption, especially in clinical settings. Tri-axial accelerometer-based consumer wearable devices have gained worldwide popularity and hold potential for a cost-effective alternative. The lack of independent validation of minute-to-minute accelerometer data with polysomnographic data or even research-grade actigraphs, as well as access to raw data has hindered the utility and acceptance of consumer-grade actigraphs.MethodsSleep clinic patients wore a consumer-grade wearable (Huami Arc) on their non-dominant wrist while undergoing an overnight polysomnography (PSG) study. The sample was split into two, 20 in a training group and 21 in a testing group. In addition to the Arc, the testing group also wore a research-grade actigraph (Philips Actiwatch Spectrum). Sleep was scored for each 60-s epoch on both devices using the Cole-Kripke algorithm.ResultsBased on analysis of our training group, Arc and PSG data were aligned best when a threshold of 10 units was used to examine the Arc data. Using this threshold value in our testing group, the Arc has an accuracy of 90.3%±4.3%, sleep sensitivity (or wake specificity) of 95.5%±3.5%, and sleep specificity (wake sensitivity) of 55.6%±22.7%. Compared to PSG, Actiwatch has an accuracy of 88.7%±4.5%, sleep sensitivity of 92.6%±5.2%, and sleep specificity of 60.5%±20.2%, comparable to that observed in the Arc.ConclusionsAn optimized sleep/wake threshold value was identified for a consumer-grade wearable Arc trained by PSG data. By applying this sleep/wake threshold value for Arc generated accelerometer data, when compared to PSG, sleep and wake estimates were adequate and comparable to those generated by a clinical-grade actigraph. As with other actigraphs, sleep specificity plateaus due to limitations in distinguishing wake without movement from sleep. Further studies are needed to evaluate the Arc's ability to differentiate between sleep and wake using other sources of data available from the Arc, such as high resolution accelerometry and photoplethysmography.
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Project description:Study objectiveThe objective of this study was to assess the accuracy of automatic diagnosis of obstructive sleep apnea (OSA) with a new, small, acoustic-based, wearable technology (AcuPebble SA100), by comparing it with standard type 1 polysomnography (PSG) diagnosis.Material and methodsThis observational, prospective study was carried out in a Spanish hospital sleep apnea center. Consecutive subjects who had been referred to the hospital following primary care suspicion of OSA were recruited and underwent in-laboratory attended PSG, together with the AcuPebble SA100 device simultaneously overnight from January to December 2022.ResultsA total of 80 patients were recruited for the trial. The patients had a median Epworth scoring of 10, a mean of 10.4, and a range of 0-24. The mean AHI obtained with PSG plus sleep clinician marking was 23.2, median 14.3 and range 0-108. The study demonstrated a diagnostic accuracy (based on AHI) of 95.24%, sensitivity of 92.86%, specificity of 97.14%, positive predictive value of 96.30%, negative predictive value of 94.44%, positive likelihood ratio of 32.50 and negative likelihood ratio of 0.07.ConclusionsThe AcuPebble SA100 (EU) device has demonstrated an accurate automated diagnosis of OSA in patients undergoing in-clinic sleep testing when compared against the gold-standard reference of in-clinic PSG.
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Project description:BackgroundVariations in body temperature are highly informative during an illness. To date, there are not many adequate studies that have investigated the feasibility of a wearable wrist device for the continuous monitoring of body surface temperatures in humans.ObjectiveThe objective of this study was to validate the performance of HEARThermo, an innovative wearable device, which was developed to continuously monitor the body surface temperature in humans.MethodsWe implemented a multi-method research design in this study, which included 2 validation studies-one in the laboratory and one with human subjects. In validation study I, we evaluated the test-retest reliability of HEARThermo in the laboratory to measure the temperature and to correct the values recorded by each HEARThermo by using linear regression models. We conducted validation study II on human subjects who wore HEARThermo for the measurement of their body surface temperatures. Additionally, we compared the HEARThermo temperature recordings with those recorded by the infrared skin thermometer simultaneously. We used intraclass correlation coefficients (ICCs) and Bland-Altman plots to analyze the criterion validity and agreement between the 2 measurement tools.ResultsA total of 66 participants (age range, 10-77 years) were recruited, and 152,881 completed data were analyzed in this study. The 2 validation studies in the laboratory and on human skin indicated that HEARThermo showed a good test-retest reliability (ICC 0.96-0.98) and adequate criterion validity with the infrared skin thermometer at room temperatures of 20°C-27.9°C (ICC 0.72, P<.001). The corrected measurement bias averaged -0.02°C, which was calibrated using a water bath ranging in temperature from 16°C to 40°C. The values of each HEARThermo improved by the regression models were not significantly different from the temperature of the water bath (P=.19). Bland-Altman plots showed no visualized systematic bias. HEARThermo had a bias of 1.51°C with a 95% limit of agreement between -1.34°C and 4.35°C.ConclusionsThe findings of our study show the validation of HEARThermo for the continuous monitoring of body surface temperatures in humans.
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Project description: Not available
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