RecruitingNot ApplicableNCT06522815

Updating Deep Learning Algorithms for OSA Monitoring

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


Sponsor

Sky Labs

Enrollment

107 participants

Start Date

Oct 19, 2022

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 19 Years

Inclusion Criteria3

  • 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 Criteria4

  • 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)

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Interventions

DEVICECART-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.

DEVICEPolysomnography

In polysomnography, the following data are collected: Electrocardiogram (ECG), Electroencephalogram (EEG), Electromyogram (EMG), Electrooculogram (EOG), Oxygen Saturation (SpO2) Respiratory Analysis, Body Position Monitoring


Locations(1)

Gangnam Severance Hospital

Seoul, South Korea

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NCT06522815


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