Retrospective Analysis of the Determinants of Air Leakage in a Population of Obstructive Sleep Apnea Syndrome Treated With Continuous Positive Airway Pressure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 79
- 试验地点
- 3
- 主要终点
- Auto-CPAP pressure level odds ratio
研究概览
简要总结
The software embedded in recent continuous positive pressure devices enables the analysis of the level of leakage that occurs during treatment around the mask or from the mouth. However, there is no clear threshold defining when it would be appropriate to implement means for correcting these leaks. In addition, the calculation methods used to detect/measure leaks and the terminology used vary according to the manufacturers of continuous pressure devices, which also complicates the clinical interpretation of the leakage reports provided by the various devices.
In daily practice, when a patient complains of unintentional leakage, technicians adjust the mask, replace the nasal-mask by an oro-nasal mask or install a chinstrap. Nevertheless, those strategies are not always effective in reducing leakage or patient's complaints. A better understanding of the mechanisms beyond leak appearance for a given patient could lead to individualised leak-treatment solutions. Pressure level, mandibular behaviour, respiratory effort, sleep position or sleep stages may contribute to leak emergence.
A recent exploratory study has proposed a genuine analysis method of determining factors of unintentional-leaks using polysomnographic recordings in OSA patients treated with automatic Continuous Positive Airway Pressure (auto-CPAP). Based on the same methodology, the NOMICS company (Liège, Belgium) has developed a polygraphic device (Brizzy®) recording unintentional leakage during auto-CPAP treatment and providing an etiological analysis of unintentional-leaks via a software named APIOS.
Due to the innovative nature of the analysis, it appears necessary to validate it onto a population of OSA patients treated with auto-CPAP. Also, to our knowledge, there is no descriptive data of the distribution of the determinants of unintentional leaks in such a population. From this perspective, the investigators aim to retrospectively analyse some polygraphic recordings that have been performed with the Brizzy® on OSA patients treated with auto-CPAP.
The primary objective of this study is to identify and describe the determinants of unintentional leaks for a population of patients with OSA and treated with an auto-CPAP device
详细描述
The secondary objectives are:
- to evaluate the concordance of the determinants of leaks according to different leak thresholds (0 l/min ; 5l/min ; 10l/min : 20l/min).
- to describe any technical problems that arise in relation to the analysis of leaks in the study population.
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
- •Sleep recordings from patients with OSA treated via auto-CPAP and monitored with Brizzy® device (including measures of non-intentional leaks) between June 1st and December 31th, 2017.
排除标准
- •The patient opposes the usage of his/her data
- •Minors or adults under any kind of guardianship
- •Fixed pressure
- •Bilevel positive airway pressure devices
- •Adaptive servo-ventilation
结局指标
主要结局
Auto-CPAP pressure level odds ratio
时间窗: day 0 (transversal study)
For each patient presenting with an unintentional leak, determination of odds ratios for Auto-CPAP pressure level
Mouth-opening odds ratio
时间窗: day 0 (transversal study)
For each patient presenting with an unintentional leak, determination of odds ratios for mouth-opening.
Sleep position odds ratio
时间窗: day 0 (transversal study)
For each patient presenting with an unintentional leak, determination of odds ratios for sleep position
Respiratory effort (increase in the Jawac signal > 0.3 mm) odds ratio
时间窗: day 0 (transversal study)
For each patient presenting with an unintentional leak, determination of odds ratios respiratory effort
次要结局
- Occurrence of nasal obstruction(day 0 (transversal study))
- Occurrence of mouth dryness(day 0 (transversal study))
- Pichot scale(day 0 (transversal study))
- Occurrence of nasal dryness(day 0 (transversal study))
- Epworth scale score(day 0 (transversal study))