Sleepiz One+

Abstract

Sleepiz One+ is a 510(okay) FDA cleared (8/18/23) contactless nearable system supposed to measure HR, RR, and motion in grownup sufferers at relaxation or throughout sleep. It’s CE (European) cleared, however not FDA cleared, as an HSAT. It isn’t indicated for energetic affected person monitoring, pregnant girls, or sufferers with energetic implantable gadgets. Sleepiz One+ makes use of Doppler radar know-how to gather and course of motion and ring SpO2 after which use proprietary machine studying to offer HR, RR, motion, and sleep information (see claims). The system is positioned beside barely greater than the mattress degree, the place it detects affected person’s actions throughout sleep or at relaxation. In accordance with the corporate, the Sleepiz One+ nearable permits contactless detection of coronary heart fee and respiration fee by sensing chest displacements originating from affected person heartbeats and respiratory exercise. The recorded indicators are transmitted to cloud software program, analyzed utilizing machine studying, after which displayed in an internet app together with AHI, sleep phases, and different sleep measures. There are not any place or apnea kind information ouputs. A pubmed search (9/9/24) supplied one efficiency validation examine for an AHI 15 cutoff, and none for sleep instances/phases. The ouput information will be accessed by a well being care skilled for retrospective evaluation to remotely monitor the affected person’s physiological indicators, or by sufferers to watch their important indicators. Sleepiz One+ could also be prescribed and reportedly could also be reimbursable for distant affected person monitoring utilizing CPT codes.

Claimed Capabilities/Measurements

The web site claims it gives “as much as 100x extra sleep and important information units at diminished price in comparison with gold commonplace PSG.” It’s 510(okay) FDA cleared as a contactless system supposed to measure HR, RR, and motion in grownup sufferers at relaxation or throughout sleep, and CE (European) cleared as an HSAT. With radar know-how, it claims to measure actions with sub-millimeter accuracy and to make use of machine studying to offer HR, RR, actions, and to categorise sleep patterns and outputs together with AHI, CPC, Sleep Levels, TST, SE, SL, awakenings, WASO. It features a system, SpO2 ring (blue tooth integration), pill (for information transmission), app, and directions. The web site claims < 3 min for setup and seamless information transmission of 28 out of 30 days.

Mechanism

Doppler radar know-how (movement); ring SpO2

Sensors

Doppler radar; ring SpO2

Technical Issues

N/A

Publications and Associated Abstracts

Quotation: Gross-Isselmann JA, Eggert T, Wildenauer A, Dietz-Terjung S, Grosse Sundrup M, Schoebel C. Validation of the Sleepiz One + as a radar-based sensor for contactless analysis of sleep apnea. Sleep Breath. 2024 Aug;28(4):1691-1699. doi: 10.1007/s11325-024-03057-6. Epub 2024 Could 14. PMID: 38744804; PMCID: PMC11303430

DOI: https://doi.org/10.1007/s11325-024-03057-6

URL: https://hyperlink.springer.com/article/10.1007/s11325-024-03057-6

Business Assist: Sure

Validation Examine: Sure

Comparability Check(s): PSG (Nox A1 PSG system)

Examine Abstract: A complete of 141 grownup individuals together with 120 sufferers (69 males: imply age 53.5 years ± 15.8 (SD) years, 22–88 years; 51 females: 57.1 years ± 13.8 years, 22–89 years) with suspected OSA and 21 wholesome volunteers (15 males: 43.5 years ± 16.7 years, 19–73 years; 6 females: 34 years ± 12.1 years, 24–55 years) underwent PSG and Sleepiz One+ monitoring. The correlation between the Sleepiz-AHI and the PSG-AHI with and with out extra SpO2 measurement was rp = 0.94 and rp = 0,87, respectively. The examine discovered that the Sleepiz One + system carried out properly, with an 85% sensitivity and 88% specificity (83.3% PPV and 89.7% NPV), and with added extra SpO2 sensor, it has 88% sensitivity and 98% specificity (97% PPV and 92% NPV) in figuring out reasonable to extreme OSA. The cut-off was AHI of 15 and the examine didn’t point out about its functionality for a cut-off AHI of 5. Bland–Altman plots confirmed good settlement between the 2 strategies of AHI measurement, though deviations elevated with growing AHI. The addition of the heartbeat oximetry improved distinguishing reasonable to extreme AHI.

Quotation: Tschopp S, Borner U, Caversaccio M, Tschopp Ok. Lengthy-term night-to-night variability of sleep-disordered respiratory utilizing a radar-based dwelling sleep apnea check: a potential cohort examine. J Clin Sleep Med. 2024 Jul 1;20(7):1079-1086. doi: 10.5664/jcsm.11070. PMID: 38415722; PMCID: PMC11217624

DOI: https://doi.org/10.5664/jcsm.11070

URL: https://jcsm.aasm.org/doi/10.5664/jcsm.11070

Business Assist: Sure

Validation Examine: Sure

Comparability Check(s): HSAT (WatchPAT 300)

Examine Abstract: Twenty-eight sufferers underwent 10 nights of monitoring with the nearable Sleepiz. There have been challenges with system reliability. Particularly, 14% of sufferers didn’t obtain the minimal required variety of measurements, and 16% of recordings have been excluded resulting from high quality points, largely resulting from issues with the wi-fi connection to the oxygen sensor. There was reasonable settlement for TST and imply HR however AHI and ODI have been decrease with Sleepiz in comparison with PAT (HSAT). There was AHI variability, with a regular error of measurement of 5.2 occasions/h (95% confidence interval [CI]: 4.6-5.7 occasions/h) and a minimal detectable distinction of 14.4 occasions/h (95% CI: 12.7-15.9 occasions/h). The examine noticed vital night-to-night variability in AHI measurements, maybe associated to lack of place monitoring with Sleepiz. Concerning measurement period, the examine means that 5 nights of information assortment is likely to be optimum for secure AHI outcomes. The authors concluded that Sleepiz (HSAT) monitoring over a number of nights is possible, properly tolerated, might supply decrease prices, and permit for multiple-night testing to extend accuracy. Nevertheless, validation and decreasing the failure fee are wanted for implementation within the medical routine. Examine Limitation: a small, predominantly delicate SDB cohort, no place information, and the shortage of management over variables like mattress companions.

Quotation: Bujan B, Fischer T, Dietz-Terjung S, Bauerfeind A, Jedrysiak P, Große Sundrup M, Hamann J, Schöbel C. Scientific validation of a contactless respiration fee monitor. Sci Rep. 2023 Mar 1;13(1):3480. doi: 10.1038/s41598-023-30171-4. PMID: 36859403; PMCID: PMC9975830

DOI: https://doi.org/10.1038/s41598-023-30171-4

URL: https://www.nature.com/articles/s41598-023-30171-4

Business Assist: Sure

Validation Examine: Sure

Comparability Check(s): PSG (SOMNOtouch RESP)

Examine Abstract: The settlement of instantaneous respiratory fee between the Sleepiz One+ system and the thoracic effort belt have been evaluated throughout a 20-min sleep window underneath managed situations (no physique motion) on a cohort of 19 individuals and secondly in a extra pure setting throughout a complete night time on a cohort of 139 individuals. In managed situations, the system precisely estimated RR inside 3 breaths per minute (Brpm), and through full-night monitoring of sufferers with sleep-related respiratory problems, it maintained this accuracy in 99.5% of timepoints. Regardless of some limitations, comparable to incapacity to evaluate physique place, and potential efficiency variations in pure versus medical environments, the authors concluded that Sleepiz One+ reveals promise for long-term RR monitoring resulting from its consolation and minimal intrusiveness.