The Severity Of Individual Breathing Cessation Events In Diagnostics Of Obstructive Sleep Apnea - Towards Enhanced And Individualized Estimation Of OSA Severity
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 10,000
- 试验地点
- 4
- 主要终点
- Severity of individual obstruction events over time.
研究概览
简要总结
Obstructive sleep apnea (OSA) is a common nocturnal breathing disorder characterized by complete (apnea) and partial (hypopnea) breathing cessations during sleep. Currently, clinical diagnosis of OSA is based on the clinical symptoms, especially excessive daytime sleepiness, and apnea-hypopnea index (AHI) providing a limited overview of the breathing cessation event frequency during the night. Longer obstruction events and deeper desaturations have been suggested to be more harmful than shorter and shallower events and these individual characteristics are completely neglected by conventional and currently used AHI.
The investigators have previously introduced novel diagnostic parameters incorporating the number, duration and morphology of individual obstruction events and shown that they improve the severity estimation of OSA compared to traditional measures. Even though, the novel diagnostic parameters have so far tackled some of shortcomings of AHI, they need to be refined to further increase the accuracy of the OSA severity estimation.
It has been shown that age, body mass index (BMI) and sleeping position are strongly related to the severity OSA. However, it is not thoroughly studied whether the severity of individual obstruction events progress over time (the aging process) and which factors affect to this progression. It is known that OSA patients with similar AHI values, durations of individual breathing cessation events can differ significantly. Longer and deeper events are connected to increased mortality rate in patients with moderate or severe OSA and thus, could be considered to be more detrimental than shorter and shallower ones. However, it has not been thoroughly investigated whether in severe OSA patients with identical AHI values, sleep efficiency or hypertension is related to the severity of individual breathing cessation events.
The investigators planned to explore, whether the individual breathing cessation event severity progress over time and how different confounding factors affect this progression. Furthermore, the correlation of EDS with the individual breathing cessation event severity, sleep structure, and frequency and occurrence of cortical arousals will be investigated. Also, the investigators will explore whether the percentage time of disturbed breathing from total sleep time is related to sleep efficiency or hypertension in severe OSA patients having similar AHI. Moreover, Positional therapy (PT) i.e., the avoidance of the supine posture during sleep is the treatment of choice for Positional Patients (PP) having most of their breathing abnormalities while sleeping supine. Since it is known that apneas/hypopneas are more severe while sleeping supine, this time the investigators will assess the therapeutic value of PT for severe Non Positional patients (NPP).
详细描述
Obstructive sleep apnea (OSA) is a prevalent nocturnal breathing disorder characterized by complete (apnea) and partial (hypopnea) breathing cessations during sleep 1. OSA is connected to cardiovascular disease, increased mortality rate and impairment of quality of life 2-4. Its prevalence has been estimated to be 9-27 % among middle-aged population and the prevalence is expected to increase in the future 5,6.
Currently, the most commonly used diagnostic parameter for OSA is apnea-hypopnea index (AHI) based on number of apneas and hypopneas during sleep, neglecting their durations and also durations and depths of related desaturation events. In adults OSA is diagnosed if patient has 1) AHI≥5 events/h with associated symptoms (e.g. excessive daytime sleepiness (EDS)) or medical or psychiatric disorder (e.g. hypertension or mood disorder) or 2) AHI≥15 events/h 7.
Previously, the investigators have introduced novel parameters called as obstruction severity, obstruction duration, desaturation severity, desaturation duration, and adjusted-AHI incorporating number, duration and morphology of individual obstruction events (i.e. apneas, hypopneas, and oxygen desaturations) 8,9.we have shown that these parameters can enhance the severity estimation of OSA and that the individual breathing cessation event severity is more strongly connected to increased mortality and cardiovascular morbidities than conventional AHI8,10,11. The potential of these parameters to enhance the assessment of severity of OSA has been previously investigated only using ambulatory polygraphic recordings without EEG registration. Therefore, the parameters do not take into account hypopneas followed by arousal (but not desaturation). In addition, parameters do not take into account apneas not followed by desaturation and novel parameters need to be refined to take into account also such events in order to further increase their prognostic value.
It is known that age and body mass index (BMI) are positively related with the prevalence of OSA12,13. Furthermore, AHI is higher and apneas longer in supine position compared to lateral position14-16. However, it is not thoroughly explored whether the severity of individual obstruction events progress over time and which factors affect to this progression.
EDS is a common symptom of OSA and it can be measured in various methods. The most widely used methods are Epworth Sleepiness Scale (ESS) questionnaire which measures subjective sleepiness and Multiple Sleep Latency Test (MSLT) and Maintenance of Wakefulness Test (MWT) which measure sleepiness objectively. However, the correlation between ESS score and the severity of OSA (i.e. number of obstruction events) have been shown to be poor 17. Furthermore, albeit MSLT and MWT have been shown to have better correlations with daytime functions than ESS their correlations with AHI and arousal index still remainsweak18. Therefore, it needs to be investigated whether the severity of individual breathing cessation events is correlated better with MSLT and MWT and thus, explaining with more accuracy the daytime symptoms.
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
- 16 Years 至 95 Years(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Good technical quality of polysomnographic (PSG) records
排除标准
- •Bad technical quality of polysomnographic (PSG) records
结局指标
主要结局
Severity of individual obstruction events over time.
时间窗: From the beginning until December 2019
We will explore how the duration of individual apnea and hypopnea events and duration, depth and area of individual desaturation events progress over time.
Differences in severity of individual obstruction events between patients having severe OSA according to AHI.
时间窗: From the beginning until December 2018
Severe OSA patients will be matched by AHI and the percentage time of disturbed breathing from total sleep time will be compared between these patients.
The assessment of the therapeutic value of Positional Therapy for severe Non Positional Patients (NPP)
时间窗: From the beginning until December 2018
Positional therapy is an optimal therapeutic mode for PP but since the severity of apneas/hypopneas is worst in the supine than in the lateral posture, NPP could also obtain some benefits of this therapy we will assess the value of this possible benefit.
Effect of severity of individual obstruction events on excessive daytime sleepiness.
时间窗: January 2018 until December 2019
We will investigate the correlation between the severity of individual breathing cessation events and excessive daytime sleepiness measured with objective means (i.e. Multiple Sleep Latency Test (MSLT) and Maintenance of Wakefulness Test (MWT))
Optimization of OSA severity definition.
时间窗: January 2018 until December 2020
Optimization of the diagnostic parameters of OSA which incorporates the severity of individual breathing cessation events.
次要结局
未报告次要终点
研究者
Arie Oksenberg
Arie Oksenberg, PhD- Director Sleep Disorders Unit
Loewenstein Hospital
