Screening of OSA in Hospitalized Stroke Patients Using BSP

Not Applicable

• Conditions: Stroke, Acute; Sleep-Disordered Breathing; Sleep Architecture
• Interventions: Device: Belun Sleep platform

• Registration Number: NCT05466864
• Lead Sponsor: Taipei Medical University Shuang Ho Hospital

Brief 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.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-04
• Status Verified: 2022-07
• Study First Submitted: 2022-07-11
• Study First Submitted QC: 2022-07-18
• Last Update Submitted: 2022-07-18
• Study First Posted: 2022-07-20
• Last Update Posted: 2022-07-20
• Primary Completion: 2023-05-03
• Study Completion: 2024-05-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Hospitalized patients with confirmed acute ischemic stroke
• Age 18-80
• Able to consent

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TMU Hospital	Belun Sleep platform	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.

Primary Outcome Measures

Name	Time	Method
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)	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.

Secondary Outcome Measures

Name	Time	Method
Duration of BSP use and technically valid recording time	1 year	Duration of BSP use and technically valid recording time will be extracted from BSP for assessment feasibility of BSP testing in hospitalized patients.
Score of STOP-Bang	1 year	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.
HRV parameters (including both frequency and time domain) ,the length of hospital stay, NIH Stroke Scale (NIHSS) score, and modified Rankin score (mRS)	1 year	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.

Trial Locations

Locations (1)

Taipei Medical University Shuang Ho Hospital; 🇨🇳 New Taipei City, Taiwan