Apple recently introduced a feature for the Apple Watch that alerts users to potential obstructive sleep apnea (OSA), helping to raise awareness of sleep health, particularly among individuals without noticeable symptoms. However, there are important considerations for consumers using consumer-grade wearables or software as medical devices (SaMD) to detect sleep apnea: 

1) Limited Accuracy for clinical diagnosis

Consumer-grade wearables, including the Apple Watch, often exhibit moderate accuracy suited for general health monitoring rather than clinical diagnosis. For example, the Apple Watch can only detect severe OSA, potentially missing individuals with mild or moderate OSA and providing false reassurance. Even detected cases of severe OSA may not always be accurate, leading to potential misdiagnosis. 

2) Restricted Metrics and Misinterpretations

These devices typically measure basic health metrics with limited data points and precision. They often inaccurately derive critical sleep parameters based on standards from the American Academy of Sleep Medicine (AASM). For smartphone acoustic apps, users should note that sleep measurements can be compromised by the presence of bed partners or pets sharing the same room.  This can result in misinterpretations and confusion when physicians attempt to explain inconsistencies in wearables or software-derived reports to patients. 

Many wearable devices and sleep apps track basic health data but may not be very accurate. They often estimate important sleep details using methods that don’t always follow trusted medical standards, which can lead to errors.

For smartphone apps that use sound (acoustics) to measure sleep, keep in mind that the presence of a bed partner, pets, or even background noises in the room can interfere with the results. This can lead to confusion, especially when doctors try to explain why the app’s reports don’t match your actual sleep patterns.

3) Limited Validations and Limitations

Caution is necessary when relying on consumer-grade wearables or even FDA-cleared SaMD for sleep assessment. Most are validated only in healthy populations, not in real-world clinical settings. While some devices or apps might be FDA-cleared, they are typically limited to assessing the risk assessment of OSA, not providing a definitive diagnosis.

4) Data Privacy Concerns

Health data collected by wearables may be vulnerable to breaches or misuse due to commercial considerations. Many consumer-grade devices and apps do not adhere to strict data protection protocols required in clinical practice, raising concerns about privacy. 

5) Restricted to General Health and Fitness Usage

Consumer-grade wearables or SaMD should be regarded primarily as tools for general health monitoring and fitness tracking. Individuals experiencing sleep issues are strongly advised to undergo a proper sleep test for an accurate medical diagnosis.

Ultimately, while consumer wearables can increase awareness of sleep health, they are not a substitute for professional medical diagnosis and care.

What Belun is capable of ?

The Belun® Ring stands as the only FDA-cleared wearable for sleep stage classification within OSA diagnosis, achieving a high accuracy rate of 89% for moderate OSA and above. The Belun® Ring demonstrates impressive performance in sleep stage classification, achieving accuracy rates of 88% for Wake, 82% for REM sleep, and 90% for NREM sleep.⁽¹⁾ The device shows excellent sensitivity (91%) and specificity (88%) in detecting moderate to severe OSA.⁽¹⁾

Extensively validated across diverse patient populations^(1–4), the Belun® Ring has proven reliable for clinical and research applications in sleep medicine and is used by over a hundred organizations locally in Hong Kong and globally. This includes universities, academic research units, hospital authorities, clinics, dental offices, and elderly centers. Internationally, the Belun Sleep System has expanded to Asia (Singapore, Thailand, Malaysia, Taiwan, Indonesia, Australia), the U.S., and Latin America (Mexico) for both clinical and research purposes.

Partnering with Belun :

Up to now, over a hundred organizations, including HK hospital authority hospitals, medical groups, clinic groups, dentists, and elderly centers, have selected to use the Belun Sleep System, Belun Ring, and Belun® remoVital monitoring system. Many doctors read our medical journal papers, including: 

1) Strumpf Z, Gu W, Tsai CW, Chen PL, Yeh E, Leung L, et al. Belun Ring (Belun Sleep System BLS-100): Deep Learning-Facilitated Wearable Enables OSA Detection, Apnea Severity Categorization, and Sleep Stage Classification in Patients Suspected of OSA. Sleep Health. 2023 Aug;9(4):430–40. (https://journals.lww.com/jhypertension/Abstract/2023/06000/The_Belun_sleep_platform_to_diagnose_obstructive.16.aspx), 

2) 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. J Clin Sleep Med. 2020 Sep 15;16(9):1611–7.(https://jcsm.aasm.org/doi/10.5664/jcsm.8592),

3) Ou YH, Ong J, Thant AT, Koo CY, Leung L, Sia CH, et al. : The Belun Sleep platform to diagnose obstructive sleep apnea in patients with hypertension and high cardiovascular risk. J Hypertens. 2023 Jun;41(6):1011–7. (https://pubmed.ncbi.nlm.nih.gov/37071415/)

4) Yeh E, Wong E, Tsai CW, Gu W, Chen PL, Leung L, 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. 2021;16(10):e0258040. (https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0258040)

If you would like to know more about how to adopt Belun’s solution in your organization, please feel free to contact us to schedule a meeting by filling out the form below:

The post Interpreting Obstructive Sleep Apnea (OSA) Diagnoses with Consumer Wearables or Software: A Cautionary Perspective first appeared on Belun Technology.

Singapore Health Sciences Authority Approves Use of Belun Sleep System for evaluating Sleep-Related Breathing Disorders

Belun Technology, with its mission to provide innovative sleep health solutions, is pleased to announce that the Singapore Health Sciences Authority (HSA) has officially approved the Belun Sleep System for evaluating sleep-related breathing disorders. This landmark regulation allows individuals across Singapore to conduct sleep apnea tests from the comfort of their homes, a significant advancement in improving accessibility to sleep health diagnostics & also echoes their long-term strategy of preventive healthcare launched under the Healthier SG program. 

A Breakthrough in Sleep Health Access: Belun Sleep System Receives HSA Approval

With HSA’s approval, patients experiencing symptoms of sleep apnea — such as loud snoring, daytime fatigue, and disrupted sleep — can now access convenient and accurate diagnostic tools from the comfort of their own homes.

“Receiving HSA approval is a major milestone in the field of sleep health in Singapore. This advancement not only enhances patient comfort and convenience but also allows healthcare providers to diagnose sleep apnea faster and more efficiently. The ability to perform these tests at home can lead to earlier diagnosis and treatment, improving the overall quality of life for those suffering from sleep disorders. It aligns with Singapore’s emphasis on managing chronic conditions and promoting overall well-being.”  said Lydia Leung, CEO of Belun Technology.

Alignment with the current Singapore Government’s program

The approval of the Belun Sleep System aligns seamlessly with Singapore’s ongoing healthcare initiatives aimed at addressing chronic conditions such as diabetes, heart disease, and hypertension through early detection and management.

1. Chronic Disease Management: Proper sleep is essential in managing chronic diseases. The Belun Sleep System empowers healthcare providers to enhance treatment outcomes by identifying and addressing sleep-related issues that can exacerbate these conditions.
2. Health Screenings: Integrating sleep health assessments into routine health screenings, especially for individuals at risk of conditions like OSA, would facilitate discussions of sleep issues related to overall health during routine health assessments. Sleep data from Belun Sleep System would also facilitate these discussions.
3. Lifestyle Counseling: Lifestyle counseling may be included in personalized health plans to discuss lifestyle factors such as stress management, which can impact sleep. Belun Sleep analytics would empower long-term monitoring for lifestyle changes, and the increase in user engagement would also promote a gradual shift with more long-term impact.

Simplifying the Path to Diagnosis

Sleep apnea, a serious but underdiagnosed condition, can lead to complications like heart disease, stroke, and high blood pressure. Traditional diagnostic methods typically involve in-clinic sleep studies, which can be time-consuming and inconvenient.

The Belun Ring, leveraging Photoplethysmography (PPG) technology, addresses these challenges by allowing patients to:

• Perform simple at-home sleep tests.
• Monitor critical parameters such as oxygen levels, pulse rate, heart rate variability, and actigraphy.
• Receive accurate, clinically validated data for professional diagnosis and treatment recommendations.

The Benefits of Home Sleep Testing (HST)

The advent of HST represents a significant shift in how sleep apnea is diagnosed, making it easier for patients to access critical care without the constraints of traditional in-clinic testing. This innovative approach caters to the growing need for accessible, cost-effective, and reliable diagnostic tools

Here are the key benefits of HST:

• Convenience: Patients can conduct sleep studies in the comfort and privacy of their homes, eliminating the need for overnight clinic stays and minimizing disruptions to daily routines.
• Cost-Effective: Home sleep testing offers a more affordable alternative compared to traditional in-clinic sleep studies, making it accessible to a broader population.
• Timely Results: The streamlined nature of home testing enables quicker results, allowing healthcare providers to diagnose and initiate treatment earlier, which can significantly improve patient outcomes.
• Clinically Accurate: Equipped with advanced technology, HST devices such as the Belun Ring deliver clinically validated data, providing healthcare professionals with the precision needed for accurate diagnoses and effective treatment planning.

With this approval, Belun Technology is poised to redefine sleep health management in Singapore, making diagnostic tools more accessible and empowering individuals to take charge of their sleep health. This milestone reflects a leap forward in healthcare innovation and underscores the importance of sleep in overall wellness and chronic disease prevention.

Partnering with Belun :

Up to now, over a hundred organizations, including HK hospital authority hospitals, medical groups, clinic groups, dentists, and elderly centers, have selected to use the Belun Sleep System, Belun Ring, and Belun® remoVital monitoring system. Many doctors read our medical journal papers, including: 

1) “Belun® Ring Platform: a novel home sleep apnea testing system for assessment of obstructive sleep apnea” (https://jcsm.aasm.org/doi/10.5664/jcsm.8592),

2) “Detection of obstructive sleep apnea using Belun® Sleep Platform wearable with neural network based algorithm and its combined use with STOP-Bang questionnaire” (https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0258040),

3) “Belun® Ring (Belun® Sleep System BLS-100): Deep Learning-Facilitated Wearable Enables OSA Detection, Apnea Severity Categorization, and Sleep Stage Classification in Patients Suspected of OSA”  (https://journals.lww.com/jhypertension/Abstract/2023/06000/The_Belun_sleep_platform_to_diagnose_obstructive.16.aspx), 

4) “Correlation of Pulse Rate Variability(PRV) and Heart Rate Variability(HRV) Metrics During Sleep in Subjects Suspected of OSA” (https://academic.oup.com/sleep/article/46/Supplement_1/A420/7182347)

5) “The Belun sleep platform to diagnose obstructive sleep apnea in patients with hypertension and high cardiovascular risk” (https://pubmed.ncbi.nlm.nih.gov/37071415/)

If you would like to know more about how to adopt Belun’s solution in your organization, please feel free to contact us to schedule a meeting by filling out the form below:

The post Congratulations to Belun as evaluation tool for sleep-related breathing disorder in Singapore first appeared on Belun Technology.

Obstructive Sleep Apnea (OSA) is a prevalent and serious sleep disorder that affects millions of Americans. Mandibular Advancement Devices (MADs) are an effective treatment option, especially for those who cannot tolerate Continuous Positive Airway Pressure (CPAP) therapy. However, the titration process—where the device is adjusted to find the optimal advancement that effectively reduces the Apnea-Hypopnea Index (AHI)—can be time-consuming and challenging.

The Challenge: Slow Titration Process

Traditionally, the titration of MADs has relied on periodic sleep studies or follow-up appointments, often spaced weeks or months apart. During this time, patients may continue to experience poor sleep quality, daytime fatigue, and associated health risks due to insufficient control of their OSA. The intermittent nature of monitoring makes it difficult for dentists to quickly determine if adjustments are effectively lowering the AHI, leading to a prolonged titration period and delayed therapeutic outcomes.

The Solution: Daily AHI Monitoring

Integrating AHI monitoring into the treatment process can revolutionize the titration of MADs, offering a faster and more precise approach. By utilizing Belun Ring, the advanced home sleep monitoring device, which can track AHI on a nightly basis, dentists can obtain real-time data on the effectiveness of the current MAD settings.

Key Benefits of AHI Monitoring:

1. Real-Time Feedback: Dentists can access AHI data, allowing them to make timely adjustments to the MAD. This continuous feedback loop accelerates the titration process by quickly identifying the optimal device settings.
2. Increased Patient Engagement: Patients become active participants in their treatment by monitoring their own AHI. This engagement can improve adherence to therapy and encourage patients to report back on their comfortability and any residual symptoms.
3. Reduced Time to Optimal Therapy: By identifying the correct titration settings sooner, patients can achieve therapeutic AHI levels more quickly, reducing the duration of ineffective treatment periods. This leads to faster symptom relief and improved overall health outcomes.
4. Customized Treatment Plans: Daily* monitoring allows for highly individualized treatment. Dentists can fine-tune the MAD to each patient’s specific needs, improving the overall treatment outcomes.
5. Improved Clinical Efficiency: For the dental practice, daily* AHI monitoring reduces the need for frequent in-person follow-up visits solely for MAD adjustments. This efficiency allows for better resource allocation and more focused patient care.
6. Mobile app BelunPro X*: To collect the daily AHI data, Healthcare professionals make the decision if the optional mobile app will be used to get the data remotely. BelunPro X is available at both Apple App Store or Google Play.

Conclusions

AHI monitoring is a game-changer in the management of OSA with MADs. Data empowers dentists to accelerate the titration process, ensuring that patients receive the most effective treatment in the shortest possible time. This approach not only enhances treatment outcomes but also improves the overall efficiency of OSA management in dental practices across the U.S.

Adopting Belun Sleep System in the titration process of MAD treatment could mark a significant advancement in the standard of care for OSA patients, offering a faster path to better sleep and health.

Partnering with Belun :

Up to now, over a hundred organizations, including HK hospital authority hospitals, medical groups, clinic groups, dentists, and elderly centers, have selected to use the Belun Sleep System, Belun Ring, and Belun® remoVital monitoring system. Many doctors read our medical journal papers, including: 

1) “Belun® Ring Platform: a novel home sleep apnea testing system for assessment of obstructive sleep apnea” (https://jcsm.aasm.org/doi/10.5664/jcsm.8592),

2) “Detection of obstructive sleep apnea using Belun® Sleep Platform wearable with neural network based algorithm and its combined use with STOP-Bang questionnaire” (https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0258040),

3) “Belun® Ring (Belun® Sleep System BLS-100): Deep Learning-Facilitated Wearable Enables OSA Detection, Apnea Severity Categorization, and Sleep Stage Classification in Patients Suspected of OSA”  (https://journals.lww.com/jhypertension/Abstract/2023/06000/The_Belun_sleep_platform_to_diagnose_obstructive.16.aspx), 

4) “Correlation of Pulse Rate Variability(PRV) and Heart Rate Variability(HRV) Metrics During Sleep in Subjects Suspected of OSA” (https://academic.oup.com/sleep/article/46/Supplement_1/A420/7182347)

5) “The Belun sleep platform to diagnose obstructive sleep apnea in patients with hypertension and high cardiovascular risk” (https://pubmed.ncbi.nlm.nih.gov/37071415/)

If you would like to know more about how to adopt Belun’s solution in your organization, please feel free to contact us to schedule a meeting by filling out the form below:

The post Accelerating MAD Treatment for OSA Patients through AHI Monitoring  first appeared on Belun Technology.

Belun Sleep App links with FDA approved Belun Ring for sleep health monitoring

Our users would like to understand more about their health situation day by day, they will select Belun personal sleep monitoring platofrm which includes the Belun Ring and Belun Sleep App to collect overnight sleep data. Those data will then be passed to the Belun Sleep App through the bluetooth connection with the smartphone. Then users can view their sleep score which is generated by Belun proprietary algorithm. The data can be further analyzed to obtain SpO2 and Pulse Rate. The indicator will show the users the sleep quality (red color is poor sleep condition and blue color is good sleep condition). In addition, Apnea level can be shown in the Belun Sleep App. There are three other indicators can be shown in the Belun Sleep App: 1) Sleep Efficiency 2) Stress Level and 3) REM (%).

While Belun Ring can measure the health condition by sleep monitoring and digitalized to data, Belun Sleep App can convert those sleep data to vital sign and further to sleep score and releasted sleep efficiency indicators.

Online Purchase for individual and sampling

If you are individual user and would like to try Belun Ring with Belun Sleep App, pls feel free to contact us.

Partnering with Belun

Up to now, over 32 organizations partners including HK hospital authority hospitals, medial groups, clinic groups, dentists and elderly centres selected to use Belun Sleep health platform, Belun Ring and Sleep App and Belun remoVital monitoring system. Many doctors read our medical journal papers including: 1) “Belun Ring Platform: a novel home sleep apnea testing system for assessment of obstructive sleep apnea” (https://jcsm.aasm.org/doi/10.5664/jcsm.8592) and 2) “Detection of obstructive sleep apnea using Belun Sleep Platform wearable with neural network based algorithm and its combined use with STOP Bang questionnaire” (https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0258040). If you would like to know more about how to adopt Belun’s solution in your organization or home use, pls feel free to contact us to schedule a meeting by filling the form below:

The post Introduction to Belun Personal Sleep Monitoring Device first appeared on Belun Technology.