Study of Application of Forced Breath Technique While CPAP Therapy for Apnea Classification
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Accuracy of the mapping of apneas based on the Forced Breath Technique compared to the manual scoring of polysomnographic data
研究概览
简要总结
This study analyzes the application of the Forced Breath Technique (FBT) to classify apneas during CPAP therapy with a prismaLAB (device name) therapy device.
In this study the BiLevel ST (Spontaneous / Timed) therapy mode of the prismaLAB device is reduced to a CPAP pressure profile with exhalation relief by minimization of the pressure gap between exhalation and inhalation pressure.
The FBT based apnea classification of the devices firmware is matched with the by hand scoring of the polysomnographic data that is usually used to evaluate the quality of patients sleep.
详细描述
Obstructive sleep-disordered breathing is usually treated by positive airway pressure (PAP) therapy with respective devices.The devices detect, classify and store respiratory events as apneas, hypopneas and snoring to adapt the therapy pressure according to patients needs and/ or to validate therapy efficacy.
Since several years the Forced Breath Technique (FBT) is standard practice in PAP devices with a BiLevel pressure profile and a background rate to classify apneas as central or obstructive. In case of an interruption of the respiratory flow within an apnea the devices background rate applies so called "mandatory breaths" with neither a manually or by device defined pressure gap between exhalation and inhalation pressure (PDIFF). If a mandatory breath generates respiratory flow patients airways are open and the patient gets ventilated. In this case the detected apnea is classified as central. If a mandatory breath generates no or insufficient respiratory flow patients airways are impassable and the apnea is classified as an obstructive event.
Usually the size of the applied therapeutic pressure gap PDIFF is >= 4 hPa. If patients airways are open the mandatory breaths with PDIFF>= 4 hPa generate an obvious flow that submits a valid classification of apneas. Therefore the pressure gap should be preferably large. So, too, the pressure gap size should be defined as small as possible to prevent the impairment of patients sleep quality.
This pilot study targets to analyze if the application of FBT with a minor gap between inhalation and exhalation pressure (IPAP [inspiratory positive airway pressure] - EPAP [expiratory positive airway pressure] = PDIFF = 1,0 to 2,0 hPa) qualifies for an equal classification of apneas as with a PDIFF >= 4 hPa. Subsequently it serves to define the minimum size of this pressure gap.
To this effect the study is subdivided in to phases: an optimization phase and an evaluation phase.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •diagnosis of sleep-disordered breathing (AHI >= 15/h)
- •ensued or indicated CPAP titration within a routine PAP therapy setting
- •age >= 18 years
- •presence of written informed consent
- •in case of therapy control or repeated participation: total number of apneas in the ensued treatment night was > 10
排除标准
- •written informed consent is missing
- •Participation in another clinical trial that influences the initiation of (auto) CPAP treatment by specifications of device settings or titration procedure
- •NYHA (New York Heart Association) class III or IV
- •acute cardiac decompensation
- •severe arrhythmia
- •severe hypotension, particularly in combination with intravascular volume depletion
- •severe epistaxis
- •high risk of barotrauma
- •decompensated pulmonary conditions
- •pneumothorax or pneumomediastinum
- •pneumocephalus
- •cranial trauma
- •status following brain surgery or surgical intervention on the pituitary gland or the middle/inner ear
- •acute sinus infection (sinusitis), middle ear infection (otitis media) or perforated eardrum
- •dehydration
- •Exclusion Criteria Statistical Evaluation:
- •Data of patients who completed the study protocol will be excluded from statistical analysis if one of the following criteria applies:
- •there is leakage of > 50 l/min for
- •application of incorrect device settings
- •insufficient data quality of PSG (Polysomnography) -acquisition
- •the device was applied outside range of indication
- •data of diagnostic night are not acquired as a PSG
- •informed consent isn´t present
- •the total number of apneas during the treatment night with BiLevel ST is < 10
结局指标
主要结局
Accuracy of the mapping of apneas based on the Forced Breath Technique compared to the manual scoring of polysomnographic data
时间窗: 1 night (= first treatment night)
次要结局
未报告次要终点