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Belun® Sleep System

BLS-100

Belun® Sleep System BLS-100 is FDA 510(k) cleared for in-home sleep apnea tests. It allows your patients to conduct sleep tests comfortably.

  • FDA 510(k) cleared for both device and AI software
  • Clinically validated in U.S.1-3 and Asian11 populations
  • Accurate and reliable
  • Re-usable, without one-off consumable part
  • Simple and easy to use
  • Small and light-weighted
  • Cableless design, negligible sleep disturbance

Belun® Ring

Belun® Ring enables you to evaluate your sleep quality at ease. The following parameters are recorded and provided:

Belun® Sleep Platform

Complete Sleep Architecture

The Belun® Sleep System BLS-100 provides clinically validated sleep stages: Wake, NREM and REM sleep using Artificial Intelligence.1-3
The complete sleep architecture provides information on sleep quality, including :

  1. time in bed (TIB),
  2. total recording time (TRT),
  3. total sleep time (TST),
  4. sleep efficiency,
  5. sleep latency,
  6. wake duration,
  7. wake counts,
  8. wake after sleep onset (WASO),
  9. REM duration,
  10. REM percentage in TST,
  11. NREM duration,
  12. and NREM percentage in TST.

In addition, BLS-100 can estimate sleep apnea and hypopnea events related to REM and NREM sleep stages. REM AHI and NREM AHI are essential to clinicians in terms of understanding phenotypes of OSA diagnosis and therapy.

Understanding The Importance Of Multiple-night Analyses

With comfort from our wearable medical device, the patient is able to perform home sleep tests with ease. Apart from reducing the technical difficulties and expensive cost by in-lab polysomnography, the Belun Sleep System enables multiple-night analyses without limitation of the measurement period.* This provides greater accuracy by minimizing the first-night effect and averaging night-to-night variability, which is less feasible with in-lab polysomnography. Moreover, comprehensive trends on key sleep parameters, autonomic nervous system responses, and OSA severity are analyzed throughout the measurement period.

Understanding The Autonomic Nervous System Response

The autonomic nervous system (ANS) is comprised of parasympathetic and sympathetic pathways. The balance between these two pathways modulates heart rate and blood pressure on a beat-to-beat basis. Heart rate variability (HRV), a surrogate marker of ANS, is characterized as the variability of beat-to-beat intervals of the heart and typically measured using R.R. intervals. Fluctuations of R.R. intervals are mediated by sympathetic and vagal efferent activity and can be affected by physiological, pathological, physical, and psychological activity.4

When sleep is disturbed, impaired autonomic function can result in sympathetic predominance and blunted parasympathetic activity.4 Heightened sympathetic activity is linked to an increased risk of cardiovascular events of up to 46%,5 hypertension6 and OSA.7–9

The use of HRV analyses has provided a glimpse into cardiac autonomic control across sleep stages, monitoring of OSA progression and treatment response.

Our study demonstrated that the HRV derived from BLS-100 could serve as surrogates for the ones derived from PSG-ECG signals.10

PPG Signal Explained

Belun® Ring BLR-100X, an FDA 510(k) cleared Class II reflectance pulse oximeter, acquires users’ photoplethysmography (PPG). The clean PPG signals at a high sample rate (200 Hz) deliver physiological information on oxygen saturation, pulse rate, and heart rate variability (HRV). Our cutting-edge algorithms, Belun Sleep System BLS-100, capture intricate patterns of these signals and accurately estimate AHI and categorize sleep stages. Several clinical trials have validated its robust generalizability in patients even with co-morbidities.2,3,11

Belun E-shop

Belun provides medical-grade wearable devices & subscription services for Home Sleep Tests. We empower HST providers to focus on care.

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Belun® Ring HST (Trial offer)

Belun is the only brand in the market with FDA clearance on both device & AI, plus sleep stages for Sleep Apnea diagnosis.

Belun is running a special promotion with a trial price for HST providers to test the experience.

Belun® Remote Physiologic Monitoring

Belun® Ring is FDA 510(k) cleared for continuous pulse oximetry. It can record patients’ SpO2, pulse rate, and actigraphy for up to 10 hours per night. Designed with a simple recharging cradle (easy plug & play for seniors), it simplifies multiple nights of RPM data collection.

References:

1. Gu W, Leung L, Kwok KC, Wu IC, Folz RJ, Chiang AA. Belun Ring Platform: a novel home sleep apnea testing system for assessment of obstructive sleep apnea. Journal of Clinical Sleep

Medicine. 2020;16(9):1611-1617.

2. Yeh E, Wong E, Tsai CW, et al. Detection of obstructive sleep apnea using Belun Sleep Platform wearable with neural network-based algorithm and its combined use with STOP-Bang

questionnaire. PLoS ONE. 2022;16(10):e0258040.

3. Strumphf Z, Gu W, Tsai CW, et al. Belun Ring (Belun Sleep System BLS-100): Deep Learning-Facilitated Wearables Enables OSA Detection, Apnea Severity Categorization, and Sleep Stage

Classification in Patients Suspected of OSA. Sleep Health. (Accepted on March 2023)

4. Ucak S, et al. Heart rate variability and obstructive sleep apnea: Current perspectives and novel technologies. J Sleep Res. 2021;30(4).

5. Fang SC, Wu YL, Tsai PS. Heart Rate Variability and Risk of All-Cause Death and Cardiovascular Events in Patients With Cardiovascular Disease: A Meta-Analysis of Cohort Studies.

Biol Res Nurs. 2020;22(1):45-56.

6. Guzzetti S, Piccaluga E, Casati R, et al. Sympathetic predominance in essential hypertension: a study employing spectral analysis of heart rate variability. J Hypertens. 1988;6(9):711-717.

7. Aydin M, et al. Cardiac autonomic activity in obstructive sleep apnea: time-dependent and spectral analysis of heart rate variability using 24-hour Holter electrocardiograms.

Tex Heart Inst J. 2004;31(2):132-136.

8. Aytemir K, Deniz A, Yavuz B, et al. Increased myocardial vulnerability and autonomic nervous system imbalance in obstructive sleep apnea syndrome. Respir Med. 2007;101(6):1277-1282.

9. Xie J, et al. Correlation Analysis between Obstructive Sleep Apnea

Syndrome (OSAS) and Heart Rate Variability. Iran J Public Health. 2017;46(11):1502-1511.

10.Tsai CW, Gu W, Yeh E, et al. Correlation of pulse rate variability (PRV) and heart rate variability (HRV) metrics during sleep in subjects suspected of OSA. SLEEP 2023 (Accepted as Poster

Presentation)

11.Ou YH, Ong J, Thant AT, et al. The Belun sleep platform to diagnose obstructive sleep apnea in patients with hypertension and high cardiovascular risk. J Hypertens. 2023;41(6):1011-1017.