Clinical trial NCT06522815: Updating Deep Learning Algorithms for OSA Monitoring
Official title: Deep Learning Algorithm Update Using Real Patients for Out-of-hospital Obstructive Sleep Apnea Monitoring
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obstructive Sleep Apnea
Obstructive Sleep Apnea-hypopnea
Lead sponsor: Sky Labs
Sponsor class: INDUSTRY
Collaborators: name: Gangnam Severance Hospital
First posted: 2024-07-26
Enrollment: 107
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Accuracy of the algorithm and the 95% confidence interval
timeFrame: 11 hours
Secondary outcomes:
measure: Accuracy and 95% confidence intervals for each interval
timeFrame: 11 hours
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
Study officials:
affiliation: Gangnam Severance Hospital
name: Won Joo Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Kim 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.