Screening of OSA in Hospitalized Stroke Patients Using BSP

Taipei Medical University

Status: Enrolling

Conditions: Stroke, Acute; Sleep-Disordered Breathing; Sleep Architecture

Treatments: Device: Belun Sleep platform

Study type: Interventional

Funder types: Other

Identifiers

NCT05466864

N202203152

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 1 patient group

TMU Hospital

Experimental group

Description:

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.

Treatment:

Device: Belun Sleep platform