Obstructive Sleep Apnea
Conditions
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 ≥ 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
Interventions
None listed
Sponsors
Brigham and Women's Hospital
Harvard Medical School (HMS and HSDM)
Universiteit Antwerpen
University Hospital, Antwerp
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years or older. * 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
* Medication use related to sleeping disorders * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Airflow [l/s] | Retrospective, measured during the baseline polysomnography study | The primary outcome of this study is the effect of DISE site, degree and pattern of collapse on the airflow \[l/s\] as measured during the baseline polysomnography |
Countries
Belgium
Outcome results
None listed