Correlation Between Upper Airway Endoscopy and Physiological Traits of Obstructive Sleep Apnea
NCT ID: NCT04753684
Last Updated: 2021-11-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
181 participants
OBSERVATIONAL
2021-02-15
2021-10-31
Brief Summary
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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 ≥ 15/h) 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
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Diagnosis with symptomatic moderate to severe OSA (AHI ≥ 15/h).
* Underwent DISE at UZA as part of the clinical pathway for non-continuous positive airway pressure (CPAP) therapies
* Underwent a baseline diagnostic PSG at UZA max 2 years before DISE
Exclusion Criteria
* Central Sleep Apnea Syndrome.
* Medical history of known causes of tiredness by day or severe sleep disruption (insomnia, periodic leg movements, narcolepsy).
* Seizure disorder.
* Known medical history of intellectual disability, memory disorders or current psychiatric disorders (psychotic illness, major depression, or acute anxiety attacks as mentioned by the patient).
* Pregnancy
* \<4 h of data recording during the baseline PSG night
18 Years
ALL
No
Sponsors
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Brigham and Women's Hospital
OTHER
Harvard Medical School (HMS and HSDM)
OTHER
Universiteit Antwerpen
OTHER
University Hospital, Antwerp
OTHER
Responsible Party
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Locations
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UZA
Edegem, Antwerp, Belgium
Countries
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References
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Op de Beeck S, Vena D, Van de Perck E, Mann D, Azarbarzin A, Alex RM, Dieltjens M, Willemen M, Verbraecken J, Wellman A, Sands SA, Vanderveken OM. Site of Collapse during Drug-induced Sleep Endoscopy Is Associated with Polysomnographic Endotypic Traits: An Observational Study. Ann Am Thorac Soc. 2025 Oct;22(10):1567-1578. doi: 10.1513/AnnalsATS.202408-871OC.
Other Identifiers
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20/45/596
Identifier Type: -
Identifier Source: org_study_id