Belun Ring for Sleep Apnea

Recruiting at 1 trial location

Overseen By Tiffany Tsai

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Belun Technology Company Limited

Disqualifiers: Atrial fibrillation, Pacemaker, Recent surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 2 years

79 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new device, the Belun Ring, which uses advanced algorithms to help diagnose sleep apnea, a condition that causes breathing interruptions during sleep. Researchers aim to determine if this ring can accurately identify different types of sleep apnea and measure their severity. They are also evaluating how well the ring detects abnormal heart rhythms and other sleep-related changes. Individuals who have been advised by a doctor that they might have sleep apnea and have a STOP-Bang score of 3 or higher may be suitable for this trial. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research in sleep apnea diagnosis.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Belun Ring is safe for diagnosing sleep apnea?

Research shows that the Belun Ring Gen3, which uses advanced technology, is generally easy to use. The FDA has approved the Belun Sleep System, which includes this ring, indicating its safety for monitoring sleep.

In past studies, the Belun Ring accurately identified obstructive sleep apnea (OSA) and matched the severity of the condition. No major reports of negative effects have emerged, suggesting the device is safe and comfortable. The "Not Applicable" phase label often indicates it is low-risk, similar to everyday health products.

These findings suggest that the Belun Ring Gen3 is a safe choice for those interested in joining a clinical trial for sleep apnea detection. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for sleep apnea, which often involve CPAP machines or oral devices, the Belun Ring Gen3 uses state-of-the-art deep learning algorithms to monitor sleep patterns. This wearable technology offers a non-invasive, comfortable way to gather precise data on sleep disturbances. Researchers are excited because the ring's advanced algorithms have the potential to provide more personalized insights, potentially leading to better-tailored treatments and improved patient outcomes.

What evidence suggests that the Belun Ring is effective for diagnosing sleep apnea?

Research has shown that the Belun Ring, which uses advanced technology, effectively detects obstructive sleep apnea (OSA). Studies have demonstrated that it accurately identifies OSA and assesses its severity using special sensors. One study showed that the Belun Ring closely matched the results of traditional sleep tests, proving it to be a reliable tool for diagnosing OSA. The device also identifies different sleep stages and detects changes that might predict adherence to CPAP machine use. This makes the Belun Ring a promising choice for those wanting to monitor their sleep health. Participants in this trial will use the Belun Ring to further evaluate its effectiveness in a clinical setting. ^{3 4 5 6 7}

Who Is on the Research Team?

Ambrose A. Chiang, MD

Principal Investigator

University Hospitals Cleveland Medical Center

Susheel P. Patil, MD

Principal Investigator

University Hospitals Cleveland Medical Center

Kingman P. Strohl, MD

Principal Investigator

University Hospitals Cleveland Medical Center

Are You a Good Fit for This Trial?

This trial is for individuals suspected of having sleep apnea, indicated by a clinical assessment and a STOP-Bang score of 3 or higher. Participants must provide informed consent to join the study.

Inclusion Criteria

Provision of signed informed consent form

Clinically assessed and suspicious for OSA with a STOP-Bang score ≥ 3

Exclusion Criteria

Unstable cardiopulmonary status on the night of the study judged to be unsafe for sleep study by the sleep tech and/or the on-call sleep physician

I have not been hospitalized or had surgery in the last 30 days.

Full night PAP titration study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo evaluation of the BR Gen3 DL algorithms and Subxiphoid Body Sensor for diagnosing sleep disordered breathing, compared to in-lab PSG

2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Data Analysis

Analysis of biomarker dynamics and performance metrics of the BR device, including sensitivity and specificity for arrhythmia detection and sleep stage classification

3 years

What Are the Treatments Tested in This Trial?

Interventions

• Belun Ring Gen3 Deep Learning Algorithms

Trial Overview The Belun Ring with Gen3 Deep Learning Algorithms and Subxiphoid Body Sensor is being tested against in-lab polysomnography (PSG) to diagnose sleep apnea, determine its severity, identify specific types of sleep apnea, and detect arrhythmias.

How Is the Trial Designed?

Group I: UH-Participant Experimental Treatment 2 Interventions

Potential participants will be identified from patients scheduled for in-lab PSG at the two medical centers of University Hospitals

Belun Ring Gen3 Deep Learning Algorithms is already approved in United States for the following indications:

Approved in United States as Belun Sleep System for:

• Diagnosis of obstructive sleep apnea (OSA)

Who Is Running the Clinical Trial?

Belun Technology Company Limited

Lead Sponsor

Trials

8

Recruited

440+

University Hospitals Cleveland Medical Center

Collaborator

Trials

348

Recruited

394,000+

Published Research Related to This Trial

The Belun Ring Platform demonstrated strong correlation with traditional sleep studies, showing a high accuracy in predicting the apnea-hypopnea index (AHI) and total sleep time in a study of 50 adults without significant health issues.

The device showed good sensitivity (0.85) and specificity (0.87) for identifying moderate to severe sleep apnea (AHI ≥ 15 events/h), although it tended to overestimate AHI in lower ranges and underestimate in higher ranges, indicating some limitations in its accuracy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Belun Ring Platform: a novel home sleep apnea testing system for assessment of obstructive sleep apnea. Gu, W., Leung, L., Kwok, KC., et al.[2021]

The Somnofy sleep assistant demonstrated high sensitivity (0.97) and reasonable specificity (0.72) for detecting sleep compared to polysomnography (PSG), indicating it can effectively classify sleep stages in healthy individuals.

While Somnofy showed promising results in sleep stage differentiation, it had some limitations, such as underestimating total wake time and N1/N2 sleep, suggesting further research is needed to validate its performance across different populations, including children and those with sleep disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validation of sleep stage classification using non-contact radar technology and machine learning (Somnofy®). Toften, S., Pallesen, S., Hrozanova, M., et al.[2021]

The Belun Sleep Platform (BSP), a wearable ring device, shows strong correlation with traditional polysomnography (PSG) in detecting obstructive sleep apnea (OSA), with a correlation coefficient of r = 0.888, indicating it can effectively assess OSA in a home setting.

BSP demonstrated high accuracy (0.808) and sensitivity (0.931) for identifying moderate to severe OSA, even in patients with comorbidities or on heart rate-affecting medications, suggesting it is a reliable tool for clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Detection of obstructive sleep apnea using Belun Sleep Platform wearable with neural network-based algorithm and its combined use with STOP-Bang questionnaire. Yeh, E., Wong, E., Tsai, CW., et al.[2021]

The study developed four advanced neural network models to predict obstructive sleep apnea (OSA) events 30 seconds in advance using raw respiratory data from over 46,000 examples across 1,507 subjects, achieving an accuracy of 81%.

The best-performing models, 1D-CNN-LSTM and 2D-CNN-LSTM, demonstrated over 83% accuracy, sensitivity, and specificity, indicating that these models can effectively predict OSA events and could be used in devices to regulate breathing during sleep, even with low-frequency data sampling.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep Apnea Prediction Using Deep Learning. Wang, E., Koprinska, I., Jeffries, B.[2023]

In a study of 129 participants with hypertension and high cardiovascular risk, the Belun Ring demonstrated a strong correlation with traditional polysomnography for diagnosing obstructive sleep apnea (OSA), showing an intraclass correlation coefficient of 0.882.

The Belun Ring achieved high diagnostic accuracy for OSA, with a sensitivity of 95.7% and an overall accuracy of 87.4%, indicating it is a reliable alternative to polysomnography for screening at-risk individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Belun sleep platform to diagnose obstructive sleep apnea in patients with hypertension and high cardiovascular risk. Ou, YH., Ong, J., Thant, AT., et al.[2023]

A new portable sleep monitoring model using a bidirectional long and short-term memory network (BI-LSTM) was developed to detect sleep apnea syndrome (SAS) based on single-channel EEG signals from 42 subjects.

The model demonstrated high performance with an accuracy of 92.73% and precision of 84.21%, indicating its potential effectiveness for cost-effective and accessible SAS monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

BI - Directional long short-term memory for automatic detection of sleep apnea events based on single channel EEG signal. Wang, Y., Xiao, Z., Fang, S., et al.[2022]

The Belun Ring, using advanced deep learning algorithms, accurately detected obstructive sleep apnea (OSA) with an overall accuracy of 0.91 for severe cases (AHI ≥ 30) and demonstrated good performance in categorizing OSA severity across different levels.

In addition to OSA detection, the Belun Ring effectively classified sleep stages, achieving an accuracy of 0.90 for REM sleep, indicating its potential as a reliable tool for both diagnosing sleep apnea and monitoring sleep quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Belun Ring (Belun Sleep System BLS-100): Deep learning-facilitated wearable enables obstructive sleep apnea detection, apnea severity categorization, and sleep stage classification in patients suspected of obstructive sleep apnea. Strumpf, Z., Gu, W., Tsai, CW., et al.[2023]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S2352721823000906

Belun Ring (Belun Sleep System BLS-100): Deep learning ... Belun Ring with second-generation algorithms detected OSA with good accuracy and demonstrated a moderate-to-substantial agreement in categorizing OSA severity ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7970584/

Belun Ring Platform: a novel home sleep apnea testing ... The objective of the study is to validate the performance of Belun Ring Platform, a novel home sleep apnea testing system using a patented pulse oximeter sensor ...

3. sleephealthjournal.org sleephealthjournal.org/article/S2352-7218(23)00090-6/fulltext

Belun Ring (Belun Sleep System BLS-100): Deep learning ... Deep learning-facilitated wearable enables obstructive sleep apnea detection, apnea severity categorization, and sleep stage classification.

4. belun.tech belun.tech/2023/03/02/fda_osa-diagnostic-device/

FDA-cleared Belun Sleep System may speed up OSA ... Belun Sleep Platform, which is comfortable and easy to use, is believed to speed up the diagnosis of 936 million worldwide with moderate to severe OSA.

5. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0258040

Detection of obstructive sleep apnea using Belun Sleep ... A total of 78 subjects were recruited. Of these, 45% had AHI < 5; 18% had AHI 5–15; 19% had AHI 15–30; 18% had AHI ≥ 30. The Belun apnea-hypopnea index (bAHI) ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf22/K222579.pdf

February 23, 2023 Belun Technology Company Limited ... The Belun Sleep System BLS-100 is a wearable device intended to record, analyze, display, export, and store biophysical parameters to aid in ...

7. beluntech.com beluntech.com/

Belun Technology – Shed Light on Your Sleep FDA-cleared Belun Sleep System may speed up OSA diagnosis for 1 billion population. Belun Technology has just received FDA 510(k) clearance from the US Food ...