The Belun Sleep System, an AI-enabled system for diagnosing Obstructive Sleep Apnea (OSA) with sleep stages classification, has received approval from the Ministry of Health and Family Welfare India as a diagnostic tool. This clearance allows more convenient and accessible diagnostic solutions for millions of Indians who suffer from sleep disorders.

Advancing Sleep Health for Millions

For individuals aged 30 to 69 years, it is estimated that about 936 million people worldwide¹ suffer from some form of OSA. In India specifically, studies show that the prevalence of OSA in adults ranges between 4.4% to 13.7% depending on gender and region. This means a substantial portion of the Indian population in this age group could have OSA, with Indian men being particularly at higher risk, where the condition could affect up to 19.7%² of males in certain studies​. 

“This is a breakthrough in India’s approach to diagnosing sleep disorders,” said Lydia Leung, CEO of Belun Technology. “With Belun Sleep System available to the Indian public, we aim to help facilitate early detection and treatment of sleep apnea, resulting in quicker, more accurate diagnoses and better treatment outcomes for the millions of Indians living with untreated sleep disorders.”

Convenient and Accessible Diagnosis

Obstructive Sleep apnea (OSA), a serious condition that affects breathing during sleep, is becoming increasingly common in India due to rising rates of obesity, stress, and lifestyle changes. Traditionally, diagnosis required overnight stays in specialized sleep clinics, which could be costly and difficult for patients to access. With the approval of Belun, patients can now undergo a sleep apnea diagnosis from the comfort of their own homes.

The newly-approved Belun Sleep System, with the use of artificial intelligence (AI) and optical technologies similar to PAT to collect physiological parameters such as pulse rate, heart rate variability, oximetry, and actigraphy, allowing healthcare professionals to remotely monitor Apnea Hyponea Index (AHI), oxygen saturation levels (SpO2), pulse rate and autonomic nervous system (ANS), without requiring patients to visit a sleep clinic. The system provides a simpler, more affordable way for patients to receive a diagnosis, particularly in areas where access to medical services may be limited.

Key Benefits of Belun Sleep System :

• Comfort: Tests can be performed in the patient’s own home, allowing for a more natural sleep environment.
• Affordability: Home testing reduces the cost burden of traditional sleep studies, making it more accessible to a larger population.
• Timely Diagnosis: Faster diagnostic results enable earlier treatment for sleep apnea, reducing the risk of associated conditions like heart disease, diabetes, and hypertension.
• Reach in Rural Areas: The Belun device empowers healthcare providers to serve patients in underserved areas, expanding the reach of sleep health diagnostics.

Expanding Healthcare Innovation in India

The approval of the Belun Sleep System in India aligns with the country’s broader healthcare goals of improving access to diagnostic services through innovative technologies. As part of this initiative, Belun Technology, a data technology provider of sleep health solutions, is committed to working with local healthcare professionals to integrate these tools into regular practice.

“India’s healthcare system is undergoing rapid transformation, and we are proud to be part of this journey,” added Lydia Leung. “By enabling patients to perform these tests at home, we aim to promote preventive healthcare and ensure that advanced medical technologies are accessible to all.”

Next Steps

With the clearance of local regulation, Belun is poised to support the roll-out of the Belun Sleep System across India. The company will collaborate with healthcare providers to offer training and educational resources on the use of these diagnostic tools, launch awareness campaigns to engage the industry and inform the public about the importance of early detection and treatment of sleep apnea.

To cope with the massive Indian market, Belun has teamed up with partners to customize end-to-end solutions for local communities.

Sources :

1/ A.V, Benjafield et al, Lancet Respiratory Medicine, 2019; 2. Susanna Ng et al, PLOS One, 2015

2/ RedMed India

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:

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