Updating Deep Learning Algorithms for OSA Monitoring

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

107 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-19

Study Completion Date

2025-07-11

Brief Summary

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The objective is to enhance the reliability of the algorithm to match that of Level 1 polysomnography by leveraging the diverse data obtained from Level 1 polysomnography to refine the deep learning algorithm.

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Detailed Description

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Patients undergoing Level 1 polysomnography are equipped with the CART-I PLUS device, for collecting polysomnography data alongside concurrent photoplethysmography (PPG) signals.

The collected data is categorized into apnea, hypopnea, and normal segments based on the polysomnography results. Utilizing the PPG and accelerometer (ACC) signals from the CART-I PLUS, metrics such as SaO2 (oxygen saturation), respiratory rate, heart rate (HR), heart rate variability (HRV), and body movement are calculated for each segment. These metrics, along with the PPG and ACC signals, are then used to develop a deep learning model that classifies the segments into apnea, hypopnea, or normal.

Participants are divided into training and validation sets. The deep learning model is trained on data from the participants in the training set, and its performance is evaluated using the validation set.

The algorithm is constructed using convolutional neural networks (CNN), recurrent neural networks (RNN), attention mechanisms, and other advanced techniques recognized for their efficacy in classification tasks, specifically for identifying apnea, hypopnea, and normal segments.

Conditions

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Obstructive Sleep Apnea Obstructive Sleep Apnea-hypopnea

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Level 1 polysomnography patient

For patients undergoing Level 1 polysomnography, simultaneous collection of photoplethysmography (PPG) signals and polysomnography data is performed using the CART-I PLUS device.

Group Type EXPERIMENTAL

CART-I plus

Intervention Type DEVICE

CART-I PLUS collects signals in two ways:

ECG: Utilizes the metal on the inner and outer sides as electrodes to detect subtle electrical changes resulting from the contraction and relaxation of the heart muscle.

PPG: Emits LED light into the blood vessels inside the finger and collects the signal reflected by the blood flow, thereby gathering data on the pulse and functional oxygen saturation (SpO2) of arterial hemoglobin.

In this clinical trial, PPG signals will be continuously collected during the polysomnography using the PPG method.

Polysomnography

Intervention Type DEVICE

In polysomnography, the following data are collected:

Electrocardiogram (ECG), Electroencephalogram (EEG), Electromyogram (EMG), Electrooculogram (EOG), Oxygen Saturation (SpO2) Respiratory Analysis, Body Position Monitoring

Interventions

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CART-I plus

CART-I PLUS collects signals in two ways:

ECG: Utilizes the metal on the inner and outer sides as electrodes to detect subtle electrical changes resulting from the contraction and relaxation of the heart muscle.

PPG: Emits LED light into the blood vessels inside the finger and collects the signal reflected by the blood flow, thereby gathering data on the pulse and functional oxygen saturation (SpO2) of arterial hemoglobin.

In this clinical trial, PPG signals will be continuously collected during the polysomnography using the PPG method.

Intervention Type DEVICE

Polysomnography

In polysomnography, the following data are collected:

Electrocardiogram (ECG), Electroencephalogram (EEG), Electromyogram (EMG), Electrooculogram (EOG), Oxygen Saturation (SpO2) Respiratory Analysis, Body Position Monitoring

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

Patients scheduled for Level 1 polysomnography at a sleep center who meet all of the following criteria:

* Aged 19 years or older
* Have listened to and understood a thorough explanation of the clinical study and voluntarily agreed to participate

Exclusion Criteria

* Under 19 years of age
* Unable to collect normal signals during the pre-test or wearing of the CART-I PLUS device
* Refuse to participate in the clinical study
* Have cognitive impairments to the extent that they cannot understand the explanation of the clinical study and therefore cannot make a voluntary decision to participate (e.g., legally incompetent individuals)

Minimum Eligible Age

19 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes