Updating Deep Learning Algorithms for OSA Monitoring

Last updated: July 22, 2024
Sponsor: Sky Labs
Overall Status: Active - Recruiting

Phase

N/A

Condition

Sleep Apnea Syndromes

Treatment

Polysomnography

CART-I plus

Clinical Study ID

NCT06522815
3-2022-0207
  • Ages > 19
  • Female
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

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 andvoluntarily agreed to participate

Exclusion

Exclusion Criteria:

  • Under 19 years of age

  • Unable to collect normal signals during the pre-test or wearing of the CART-I PLUSdevice

  • Refuse to participate in the clinical study

  • Have cognitive impairments to the extent that they cannot understand the explanationof the clinical study and therefore cannot make a voluntary decision to participate (e.g., legally incompetent individuals)

Study Design

Total Participants: 107
Treatment Group(s): 2
Primary Treatment: Polysomnography
Phase:
Study Start date:
October 19, 2022
Estimated Completion Date:
July 11, 2025

Study 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.

Connect with a study center

  • Gangnam Severance Hospital

    Seoul,
    Korea, Republic of

    Active - Recruiting

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