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NCT Number: NCT06522815

Updating Deep Learning Algorithms for OSA Monitoring

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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Key information

Age range

19 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

CART-I plus

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

Device

In polysomnography, the following data are collected:

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

Primary outcomes

  1. Accuracy of the algorithm and the 95% confidence interval

    Time frame: 11 hours

    Present the accuracy of the algorithm and the 95% confidence interval. If the lower bound of the 95% confidence interval exceeds a minimum accuracy of 0.85, it is considered clinically significant.

Secondary outcomes

  1. Accuracy and 95% confidence intervals for each interval

    Time frame: 11 hours

    Present the accuracy and 95% confidence intervals for each interval. Additionally, precision, recall, ROC curve, and AUC may be presented. The performance comparison between algorithms will use the bootstrap method, and a p-value less than 0.05 will be considered statistically significant.

Study contacts

Contact information is provided by the study sponsor or research team.

Gerrard Kim

CONTACT

[email protected]

1599-7149

Yujung Kang

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Sky Labs

Industry

Collaborators

  • Gangnam Severance Hospital

Registry information

Official study title

Deep Learning Algorithm Update Using Real Patients for Out-of-hospital Obstructive Sleep Apnea Monitoring

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jul 26, 2024
Registry last updated
Jul 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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