Sleep-Disordered BreathingNCT05466864
Screening of OSA in Hospitalized Stroke Patients Using BSP
A study testing Belun Sleep platform in people with Sleep-Disordered Breathing and Sleep Architecture, run by Taipei Medical University Shuang Ho Hospital at 1 site in Taiwan.
Trial summary
Obstructive sleep apnea (OSA) is prevalent in patients with stroke and has a negative effect on outcomes by predisposing them to recurrent stroke, increasing mortality, and so forth. Therefore, it is extremely important to identify OSA in patients with stroke. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Sleep-Disordered Breathing, Sleep Architecture, Stroke, Acute
- What is being tested?
- Belun Sleep platform
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- 4 May 2022to 3 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hospitalized patients with confirmed acute ischemic stroke
- Age 18-80
- Able to consent
Who cannot join
- History of atrial fibrillation, LVEF < 45%, pacemaker/defibrillator, left ventricular assist device (LVAD), or status post-cardiac transplantation, devastating strokes ( mRS >= 4).
- Aphasia, severe bulbar palsy, unable to comprehend, consent, or answer questionnaires.
- Unstable cardiopulmonary status.
- Recent surgery including tracheotomy in 30 days.
- On narcotics.
- On O2, PAP device, ventilator, diaphragmatic pacing, or any form of nerve stimulator
- unable to understand instructions or to accurately use BRP during the instruction session.
- Patients with technically valid recording time under 4 hours will be excluded.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Medical University Shuang Ho Hospital
New Taipei City, 235
Wen-Te Liu, MD. PhD, +886-222490088 ext. 72431, b7801077@tmu.edu.tw
About this study
Official title: Screening of Obstructive Sleep Apnea (OSA) in Hospitalized Patients Admitted for Acute Ischemic Stroke Using Belun Sleep Platform (BSP) - A Medical-Grade Wearable With Neural Network Algorithm
Obstructive sleep apnea (OSA) is prevalent in patients with stroke and has a negative effect on outcomes by predisposing them to recurrent stroke, increasing mortality, and so forth. Therefore, it is extremely important to identify OSA in patients with stroke.
Wearable devices can greatly reduce the manpower and material requirements of traditional laboratory-based polysomnography (PSG). With Photoplethysmography (PPG) technology and neural network algorithms, the Belun ring and the sleeping platform not only can detect blood oxygen, and heart rate but also can identify sleep stage and estimate the severity of sleep apnea.
Read more
In this study, inpatients with acute ischemic stroke in the hospital will proceed with three nights test for recording the parameters of the autonomic nervous system in the acute phase, evaluate whether sleep apnea and the feasibility of the Belun sleep platform.
It is important that early recognition of OSA and prompt treatment, which can potentially improve OSA-associated adverse outcomes, as well as understanding the degree of autonomic nervous function impairment for patients with acute ischemic stroke. After smoothing this process, it can help clinicians more accurately comprehend the condition, timing of admission, and discharge.
- Being tested
- Belun Sleep platform
- Keywords
- Obstructive Sleep Apnea, Central Sleep Apnea, Stroke, Sleep Position
- Medical subject headings
- Sleep Apnea Syndromes, Stroke, Sleep Apnea, Obstructive, Sleep Apnea, Central
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Belun Sleep platformDevice
BSP(Belun Technology Company Limited) is a novel wearable system using a neural network algorithm that consists of a patented wearable device (Belun Ring), a charging cradle, and cloud-based software. The Belun Ring, an FDA-cleared pulse oximeter, acquires signals from the radialis indicis artery of the proximal index finger. The Belun Ring total sleep time can be derived from features extracted from accelerometer, SpO2, and PPG signals, whereas Belun Ring AHI can be derived from Ring-TST and features extracted from HRV and SpO2 changes. The BSP proprietary OSA detection algorithm was using neural network. BSP performance can be improved by training the algorithm through continual data collection. To our knowledge, BSP is the only validated sleep platform using a medical-grade wearable pulse oximeter, actigraphy, and artificial intelligence algorithm that has the capability to identify sleep stages, detect OSA events, and monitor autonomic nervous system activity changes during sleep.
| Study group | Role | What they receive |
|---|---|---|
| TMU Hospital | Experimental | Potential participants with suspected OSA will be identified from the schedule of the TMU sleep labs. Those subjects who satisfy the study conclusion and exclusion criteria will be approached and invited to participate in the study. Receives: Device: Belun Sleep platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
AHI, duration with SpO2 < 90%, and SpO2 nadir, as well as sleep stage parameters (total sleep time [TST], wake time, REM time, and NREM time)
To specifically assess the accuracy of BSP bAHI in predicting OSA by comparing to the concurrent in-lab PSG-AHI and to determine the accuracy of BSP sleep stage parameters by comparing to the concurrent PSG.
BSP bAHI, BSP time with SpO2 < 90%, and BSP-SpO2 nadir will be extracted from BSP and compared to PSGAHI (4% hypopnea criteria), PSG time with SpO2 < 90% (PSG-T90), PSG-SpO2 nadir extracted from the concurrent PSG.
BSP sleep stage parameters (total sleep time [TST], wake time, REM time, and NREM time) will be extracted from BSP and compared to the same parameters of the concurrent PSG. Epoch-by-epoch comparison will be performed.
Measured: 1 year
Secondary outcomes (3)
Duration of BSP use and technically valid recording time
Duration of BSP use and technically valid recording time will be extracted from BSP for assessment feasibility of BSP testing in hospitalized patients.
Measured: 1 year
Score of STOP-Bang
Stop-Bang cutoff of 3, 4, and 5 will be combined with PSG-cutoff of 5 events/h, 15 events/h, and 30 events/h and compared for accuracy of OSA prediction.
Measured: 1 year
HRV parameters (including both frequency and time domain) ,the length of hospital stay, NIH Stroke Scale (NIHSS) score, and modified Rankin score (mRS)
ANS parameters including HRV frequency domain parameters (low frequency [LF], high frequency [HF], and LF/HF ratio) as well as time domain parameters (standard deviation of normal to normal R-R intervals [SDNN] and root mean square of successive heartbeat interval difference [RMSSD]) will be extracted from BSP and test the correlations with the length of hospital stay, NIH Stroke Scale (NIHSS) score, and modified Rankin score (mRS) will be analyzed.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2022
- Study start4 May 2022
- Primary completion3 May 2023 (estimated)
- Study completion3 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep-Disordered BreathingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University Shuang Ho Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Case Western Reserve University
- Responsible party
- Principal investigator, Wen-De Liu, Taipei Medical University Shuang Ho Hospital
- Investigators
- Wen-Te Liu, MD. PhD, Study director, Taipei Medical University Shuang Ho Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05466864
- Sponsor's protocol ID
- N202203152
- Status last verified
- Jul 2022
- First submitted
- 11 Jul 2022
- Last updated
- 20 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening of Obstructive Sleep Apnea (OSA) in Hospitalized Patients Admitted for Acute Ischemic Stroke Using Belun Sleep Platform (BSP) - A Medical-Grade Wearable With Neural Network Algorithm
- ClinicalTrials.gov ID
- NCT05466864
- Acronym / sponsor ID
- N202203152
- Keywords
- Obstructive Sleep Apnea, Central Sleep Apnea, Stroke, Sleep Position
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Taipei Medical University Shuang Ho HospitalUniversity, hospital or other
- Collaborators
- Case Western Reserve University
- Study start
- 4 May 2022 (actual)
- Primary completion
- 3 May 2023 (estimated)
- Study completion
- 3 May 2024 (estimated)
- First posted
- 20 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Obstructive sleep apnea (OSA) is prevalent in patients with stroke and has a negative effect on outcomes by predisposing them to recurrent stroke, increasing mortality, and so forth. Therefore, it is extremely important to identify OSA in patients with stroke.
Wearable devices can greatly reduce the manpower and material requirements of traditional laboratory-based polysomnography (PSG). With Photoplethysmography (PPG) technology and neural network algorithms, the Belun ring and the sleeping platform not only can detect blood oxygen, and heart rate but also can identify sleep stage and estimate the severity of sleep apnea.
In this study, inpatients with acute ischemic stroke in the hospital will proceed with three nights test for recording the parameters of the autonomic nervous system in the acute phase, evaluate whether sleep apnea and the feasibility of the Belun sleep platform.
It is important that early recognition of OSA and prompt treatment, which can potentially improve OSA-associated adverse outcomes, as well as understanding the degree of autonomic nervous function impairment for patients with acute ischemic stroke. After smoothing this process, it can help clinicians more accurately comprehend the condition, timing of admission, and discharge.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TMU Hospital | Experimental | Device: Belun Sleep platformPotential participants with suspected OSA will be identified from the schedule of the TMU sleep labs. Those subjects who satisfy the study conclusion and exclusion criteria will be approached and invited to participate in the study. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Hospitalized patients with confirmed acute ischemic stroke
- Age 18-80
- Able to consent
Key exclusion criteria (8 listed)
- History of atrial fibrillation, LVEF < 45%, pacemaker/defibrillator, left ventricular assist device (LVAD), or status post-cardiac transplantation, devastating strokes ( mRS >= 4).
- Aphasia, severe bulbar palsy, unable to comprehend, consent, or answer questionnaires.
- Unstable cardiopulmonary status.
- Recent surgery including tracheotomy in 30 days.
- On narcotics.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Belun Sleep platformBSP(Belun Technology Company Limited) is a novel wearable system using a neural network algorithm that consists of a patented wearable device (Belun Ring), a charging cradle, and cloud-based software. The Belun Ring, an FDA-cleared pulse oximeter, acquires signals from the radialis indicis artery of the proximal index finger. The Belun Ring total sleep time can be derived from features extracted from accelerometer, SpO2, and PPG signals, whereas Belun Ring AHI can be derived from Ring-TST and features extracted from HRV and SpO2 changes. The BSP proprietary OSA detection algorithm was using neural network. BSP performance can be improved by training the algorithm through continual data collection. To our knowledge, BSP is the only validated sleep platform using a medical-grade wearable pulse oximeter, actigraphy, and artificial intelligence algorithm that has the capability to identify sleep stages, detect OSA events, and monitor autonomic nervous system activity changes during sleep. | Device | TMU Hospital |
Primary outcome
AHI, duration with SpO2 < 90%, and SpO2 nadir, as well as sleep stage parameters (total sleep time [TST], wake time, REM time, and NREM time)
Time frame: 1 year
To specifically assess the accuracy of BSP bAHI in predicting OSA by comparing to the concurrent in-lab PSG-AHI and to determine the accuracy of BSP sleep stage parameters by comparing to the concurrent PSG. BSP bAHI, BSP time with SpO2 < 90%, and BSP-SpO2 nadir will be extracted from BSP and compared to PSGAHI (4% hypopnea criteria), PSG time with SpO2 < 90% (PSG-T90), PSG-SpO2 nadir extracted from the concurrent PSG. BSP sleep stage parameters (total sleep time [TST], wake time, REM time, and NREM time) will be extracted from BSP and compared to the same parameters of the concurrent PSG. Epoch-by-epoch comparison will be performed.
3 secondary outcomes
Duration of BSP use and technically valid recording time
Time frame: 1 year
Score of STOP-Bang
Time frame: 1 year
HRV parameters (including both frequency and time domain) ,the length of hospital stay, NIH Stroke Scale (NIHSS) score, and modified Rankin score (mRS)
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wen-Te Liu, MD. PhD study director
Taipei Medical University Shuang Ho Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Belun Sleep platform in people with Sleep-Disordered Breathing and Sleep Architecture, run by Taipei Medical University Shuang Ho Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wen-Te Liu, MD. PhD (+886-222490088 ext. 72431, b7801077@tmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AHI, duration with SpO2 < 90%, and SpO2 nadir, as well as sleep stage parameters (total sleep time [TST], wake time, REM time, and NREM time) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2022.