Ignite Creation Date:
2024-05-06 @ 3:46 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04753684
Status:
COMPLETED
Last Update Posted:
2021-11-30
First Post:
2021-01-11
Brief Title:
Correlation Between Upper Airway Endoscopy and Physiological Traits of Obstructive Sleep Apnea
Sponsor:
University Hospital Antwerp
Organization:
University Hospital Antwerp
Study Overview
Official Title:
Correlation Between Upper Airway Endoscopy and Physiological Traits of Obstructive Sleep Apnea a Retrospective Study
Status:
COMPLETED
Status Verified Date:
2021-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
OBJECTIVES
To train and test a mathematical model to predict complete concentric collapse at the level of the palate CCCp primary and other sites of upper airway collapse secondary during drug-induced sleep endoscopy DISE using the data captured during a diagnostic polysomnography PSG
HYPOTHESIS
The site pattern and degree of upper airway collapse is associated with distinct flow features as captured during a baseline PSG
STUDY DESIGN
Retrospective trial
STUDY POPULATION
200 patients with moderate to severe obstructive sleep apnea OSA AHI 15h who underwent both a DISE and a diagnostic PSG at the Antwerp University Hospital UZA between January 2018 and December 2020
OUTCOME MEASURES
Raw data as captured during a diagnostic PSG including electroencephalography EEG flow electrocardiography ECG electromyography EMG oxygen desaturation and breathing effort
SAMPLE SIZE DATA ANALYSIS
Data of 200 patients will be retrospectively included into this study protocol Different machine learning techniques will be adopted to select features train the model and test the model
TIME SCHEDULE
January 30 2021 - November 30 2021
To train and test a mathematical model to predict complete concentric collapse at the level of the palate CCCp primary and other sites of upper airway collapse secondary during drug-induced sleep endoscopy DISE using the data captured during a diagnostic polysomnography PSG
HYPOTHESIS
The site pattern and degree of upper airway collapse is associated with distinct flow features as captured during a baseline PSG
STUDY DESIGN
Retrospective trial
STUDY POPULATION
200 patients with moderate to severe obstructive sleep apnea OSA AHI 15h who underwent both a DISE and a diagnostic PSG at the Antwerp University Hospital UZA between January 2018 and December 2020
OUTCOME MEASURES
Raw data as captured during a diagnostic PSG including electroencephalography EEG flow electrocardiography ECG electromyography EMG oxygen desaturation and breathing effort
SAMPLE SIZE DATA ANALYSIS
Data of 200 patients will be retrospectively included into this study protocol Different machine learning techniques will be adopted to select features train the model and test the model
TIME SCHEDULE
January 30 2021 - November 30 2021
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None