Updating Deep Learning Algorithms for OSA Monitoring

Sky Labs

Status: Enrolling

Conditions: Obstructive Sleep Apnea-hypopnea; Obstructive Sleep Apnea

Treatments: Device: CART-I plus; Device: Polysomnography

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06522815

3-2022-0207

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 107 estimated patients

Sex: Female

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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107 participants in 1 patient group

Level 1 polysomnography patient

Experimental group

Description:

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

Treatment:

Device: Polysomnography

Device: CART-I plus