Correlation Between Upper Airway Endoscopy and Physiological Traits of Obstructive Sleep Apnea: a Retrospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 181
- 试验地点
- 1
- 主要终点
- Airflow [l/s]
研究概览
简要总结
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Airflow [l/s]
时间窗: 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
次要结局
未报告次要终点