Validation of Breathing Event Detection of the Philips Respironics Sleep Therapy System REMstar Auto A-Flex Compared to Clinical Polysomnography
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 6
- 主要终点
- Number of Breathing Events Identified by the Continuous Positive Airway Pressure (CPAP) Device Compared to a Simultaneous Polysomnography
研究概览
简要总结
The purpose of this study is to demonstrate diagnostic agreement and determine the accuracy of the continuous positive airway pressure (CPAP) device compared to simultaneous, attended clinical polysomnography (PSG) in identifying breathing events in participants previously diagnosed with complex sleep apnea (CompSAS), complex sleep apnea with Cheyne-Stokes respiration (CSR), or obstructive sleep apnea (OSA).
详细描述
Study Objectives: To compare a positive airway pressure (PAP) device's detection of respiratory events and airway status during device detected apneas with events scored on simultaneous polysomnography (PSG).
Design: Prospective PSGs of patients with sleep apnea using a new-generation PAP device.
Settings: Four clinical and academic sleep centers.
Patients: Forty-five patients with obstructive sleep apnea (OSA) and complex sleep apnea (Comp SA) performed a PSG on PAP levels adjusted to induce respiratory events.
Interventions: None.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females, ages 21-
- •Able and willing to provide written informed consent.
- •Diagnosis of complex sleep apnea (CompSAS) or Obstructive Sleep Apnea (OSA) within one year of study participation.
- •For participants with CompSAS: (a) Diagnostic PSG with an Apnea-Hyopnea Index (AHI) greater than or equal to 10 events/hour and central apnea index (CAI) greater than or equal to 5 events/hour of sleep or (b) PAP titration with a CAI greater than or equal to 5 events/hour of sleep.
- •For participants with OSA, a diagnostic PSG with an AHI greater than or equal to 15 events/hour of sleep.
- •Must have had a CPAP titration such that the necessary PAP level to treat the sleep disordered breathing is known.
- •Agreement to undergo a full-night, in-laboratory PSG on CPAP device.
排除标准
- •Participation in an interventional research study within 30 days of study participation.
- •Pre-menopausal females known to be pregnant or who are sexually active and not using a reliable method of birth control.
- •Surgery of the upper airway, nose, sinus, or middle ear within the last 90 days.
- •Surgery at any time for the treatment of OSA such as uvulopalatopharyngoplasty (UPPP).
- •Major medical or psychiatric condition that would interfere with the demands of the study, adherence to positive airway pressure, or the ability to complete the study.
- •Chronic respiratory failure or insufficiency with suspected or known neuromuscular disease, moderate or severe Chronic Obstructive Pulmonary Disease (COPD) or other pulmonary disorders, or any condition with an elevation of arterial carbon dioxide levels (> 45 mmHg) while awake.
- •Currently prescribed oxygen therapy.
- •Ventilatory induced barotrauma within 6 months of study participation.
- •Untreated insomnia.
- •Other major medical condition that, in the judgment of the investigator, precludes participation in this study.
研究组 & 干预措施
REMstar Auto with A-Flex
Manipulation of positive airway pressure (PAP) will occur throughout the night to induce breaking events. PAP will be set to the participant's prescribed pressure, increased until breathing events are induced, and then returned to the prescribed pressure. This cyclic pattern will continue throughout the night. Events will be measured with REMstar Auto with A-Flex.
干预措施: Manipulation of Positive Airway Pressure (PAP) (Other)
Manually Scored Polysomnography (PSG)
Manipulation of positive airway pressure (PAP) will occur throughout the night to induce breaking events. PAP will be set to the participant's prescribed pressure, increased until breathing events are induced, and then returned to the prescribed pressure. This cyclic pattern will continue throughout the night. Events will be Manually Scored Polysomnography (PSG).
干预措施: Manipulation of Positive Airway Pressure (PAP) (Other)
结局指标
主要结局
Number of Breathing Events Identified by the Continuous Positive Airway Pressure (CPAP) Device Compared to a Simultaneous Polysomnography
时间窗: During a single night of polysomnography lasting an average of 8 hours
The following breathing events: RERAs, central apneas, periodic breathing, obstructive apneas, and hypopneas in patients previously diagnosed with CompSAS or OSA detected by simultaneous Polysomnography and REMstar Auto with A-Flex were compared.
次要结局
- Device-Detected Clear Airway Apnea Agreement(During a single night of polysomnography lasting an average of 8 hours)
- Device-Detected Obstructed Airway Apnea Agreement(During a single night of polysomnography lasting an average of 8 hours)
- Device Detected Apneas as Detected by Philips Respironics (PR) System One(During a single night of polysomnography lasting an average of 8 hours)