Updating Deep Learning Algorithms for OSA Monitoring
Deep Learning Algorithm Update Using Real Patients for Out-of-hospital Obstructive Sleep Apnea Monitoring
1 other identifier
interventional
107
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 19, 2022
CompletedFirst Submitted
Initial submission to the registry
July 22, 2024
CompletedFirst Posted
Study publicly available on registry
July 26, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 22, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 11, 2025
CompletedJuly 26, 2024
July 1, 2024
2.5 years
July 22, 2024
July 22, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Accuracy of the algorithm and the 95% confidence interval
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.
11 hours
Secondary Outcomes (1)
Accuracy and 95% confidence intervals for each interval
11 hours
Study Arms (1)
Level 1 polysomnography patient
EXPERIMENTALFor patients undergoing Level 1 polysomnography, simultaneous collection of photoplethysmography (PPG) signals and polysomnography data is performed using the CART-I PLUS device.
Interventions
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.
In polysomnography, the following data are collected: Electrocardiogram (ECG), Electroencephalogram (EEG), Electromyogram (EMG), Electrooculogram (EOG), Oxygen Saturation (SpO2) Respiratory Analysis, Body Position Monitoring
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sky Labslead
- Gangnam Severance Hospitalcollaborator
Study Sites (1)
Gangnam Severance Hospital
Seoul, South Korea
Related Publications (4)
Peppard PE, Young T, Palta M, Skatrud J. Prospective study of the association between sleep-disordered breathing and hypertension. N Engl J Med. 2000 May 11;342(19):1378-84. doi: 10.1056/NEJM200005113421901.
PMID: 10805822BACKGROUNDArzt M, Young T, Finn L, Skatrud JB, Bradley TD. Association of sleep-disordered breathing and the occurrence of stroke. Am J Respir Crit Care Med. 2005 Dec 1;172(11):1447-51. doi: 10.1164/rccm.200505-702OC. Epub 2005 Sep 1.
PMID: 16141444BACKGROUNDDoherty LS, Kiely JL, Swan V, McNicholas WT. Long-term effects of nasal continuous positive airway pressure therapy on cardiovascular outcomes in sleep apnea syndrome. Chest. 2005 Jun;127(6):2076-84. doi: 10.1378/chest.127.6.2076.
PMID: 15947323BACKGROUNDKim J, In K, Kim J, You S, Kang K, Shim J, Lee S, Lee J, Lee S, Park C, Shin C. Prevalence of sleep-disordered breathing in middle-aged Korean men and women. Am J Respir Crit Care Med. 2004 Nov 15;170(10):1108-13. doi: 10.1164/rccm.200404-519OC. Epub 2004 Sep 3.
PMID: 15347562BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Won Joo Kim, MD, PhD
Gangnam Severance Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 22, 2024
First Posted
July 26, 2024
Study Start
October 19, 2022
Primary Completion
April 22, 2025
Study Completion
July 11, 2025
Last Updated
July 26, 2024
Record last verified: 2024-07