Clinical trial NCT05466864: Screening of OSA in Hospitalized Stroke Patients Using BSP
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sleep-Disordered Breathing
Sleep Architecture
Stroke, Acute
Keywords: Obstructive Sleep Apnea
Central Sleep Apnea
Stroke
Sleep Position
Lead sponsor: Taipei Medical University Shuang Ho Hospital
Sponsor class: OTHER
Collaborators: name: Case Western Reserve University
First posted: 2022-07-20
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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.

Primary outcomes:
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)
timeFrame: 1 year
Secondary outcomes:
measure: Duration of BSP use and technically valid recording time
timeFrame: 1 year
measure: Score of STOP-Bang
timeFrame: 1 year
measure: HRV parameters (including both frequency and time domain) ,the length of hospital stay, NIH Stroke Scale (NIHSS) score, and modified Rankin score (mRS)
timeFrame: 1 year
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Taipei Medical University Shuang Ho Hospital
Study officials:
affiliation: Taipei Medical University Shuang Ho Hospital
name: Wen-Te Liu, MD. PhD
role: STUDY_DIRECTOR
References: