Status:
RECRUITING
Updating Deep Learning Algorithms for OSA Monitoring
Lead Sponsor:
Sky Labs
Collaborating Sponsors:
Gangnam Severance Hospital
Conditions:
Obstructive Sleep Apnea
Obstructive Sleep Apnea-hypopnea
Eligibility:
FEMALE
19+ years
Phase:
NA
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 a...
Detailed 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 i...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
October 19 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 11 2025
Estimated Enrollment :
107 Patients enrolled
Trial Details
Trial ID
NCT06522815
Start Date
October 19 2022
End Date
July 11 2025
Last Update
July 26 2024
Active Locations (1)
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1
Gangnam Severance Hospital
Seoul, South Korea