A Multicenter, Single-Arm, Safety and Efficacy Study of the Resvent RXiBreeze™ PAP System to Treat Obstructive Sleep Apnea
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 146
- 试验地点
- 18
- 主要终点
- AHI Event Detection
研究概览
简要总结
The goal of this clinical trial is to test the automatic positive airway pressure (APAP) function of the RXiBreeze PAP System in adult subjects with obstructive sleep apnea (OSA). The main questions the study aims to answer are:
- Is apnea-hypopnea index (AHI) detection using the RXiBreeze PAP System equivalent to apnea-hypopnea index (AHI) detection using PSG?
- What is the responder rate using the RXiBreeze PAP System?
Participants will use the APAP function of the RXiBreeze PAP System while undergoing polysomnography (PSG) for two separate nights in a sleep center. During each visit, participants will also complete two patient reported outcome questionnaires:
- Epworth Sleepiness Score (ESS); and
- Functional Outcomes of Sleep Questionnaire (FOSQ) short form.
详细描述
This is a prospective, multicenter, single-arm trial designed to evaluate the safety and effectiveness of the RXiBreeze PAP System to treat obstructive sleep apnea and detect breathing events. Eligible subjects who meet all inclusion criteria and none of the exclusion criteria will be consented for study participation. The study will enroll up to 68 subjects. Baseline PSG will be obtained. Subjects will return to the sleep lab and use the RXiBreeze PAP System while undergoing a PSG. The data from both the RXiBreeze PAP System and PSG from both nights will be sent to an independent core lab for blinded AHI scoring. Data will be evaluated in accordance with current American Academy of Sleep Medicine (AASM) scoring guidelines. In addition to the device/PSG data scoring, subjects will complete the Epworth Sleepiness Score (ESS) and the Functional Outcomes of Sleep Questionnaire (FOSQ) short form (10 questions) and be assessed for device- and/or therapy-related adverse events (AEs) at the end of each visit.
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
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is ≥ 22 years old
- •Subject has been diagnosed with OSA (as scored per AASM scoring guidelines) and has an AHI ≥ 10, based on the results of a sleep study conducted at an accredited sleep lab, within 30 days prior to enrollment
- •Subject weighs >30 kg
- •Subject has been prescribed the use of an Auto CPAP system
- •Subject agrees to fulfill all study-required tests, sleep lab session attendance, and assessments
- •Subject agrees to use the RXiBreeze PAP System as prescribed
- •Subject is willing and able to provide informed consent
排除标准
- •Subject has been diagnosed with a sleep disorder other than OSA
- •Subject's Central Apnea Index from the baseline PSG is > 20% of AHI
- •Subject has been diagnosed with severe (stage 3) coronary artery disease
- •Subject has been diagnosed with bullous lung disease
- •subject has been diagnosed with hypotension
- •subject has been diagnosed with bypassed upper airway pneumothorax
- •Subject is pregnant, breastfeeding, or planning on becoming pregnant during trial participation
- •Subject, in the opinion of the investigator, is not suitable for trial participation
结局指标
主要结局
AHI Event Detection
时间窗: Night 1
Apnea-Hypopnea Index (AHI) as measured by the test device (RXiBreeze PAP System) will be compared to the AHI as measured by polysomnography (PSG) to determine equivalence at night 1. Equivalence will be considered if the mean difference in detected AHI is greater than the lower equivalence limit (EL) of -5 and less than the upper equivalence limit (EU) of 5.
Responder Rate
时间窗: Night 1
RXiBreeze PAP System Night 1 responder rate as compared to a performance goal of 50. Responder rate is based on Sher's Criteria, which are defined as having both a ≥ 50% reduction in AHI and a final AHI of \< 20 events per hour.
次要结局
- Epworth Sleepiness Scale (ESS) on Night 1 and Night 7(Nights 1 and 7)
- Night 7 responder rate(Night 7)
- Event Detection Validation - Obstructive Apnea Index (OAI) on Night 1 and Night 7(Nights 1 and 7)
- Night 1 responder rate by baseline disease severity(Night 1)
- Night 7 RXiBreeze PAP System compliance rate(Night 7)
- Nights 1 and 7 percentage of time oxygen saturation is < 90% (T90)(Nights 1 and 7)
- Event Detection Validation: Apnea Index (AI) on Night 1 and Night 7(Nights 1 and 7)
- Nights 1 and 7 Oxygen Desaturation Index (ODI)(Nights 1 and 7)
- Event Detection Validation: Hypopnea Index (HI) on Night 1 and Night 7(Nights 1 and 7)
- Functional Outcomes of Sleep Questionnaire short form (FOSQ-10) on Night 1 and Night 7(Nights 1 and 7)
- Event Detection Validation: Central Apnea Index (CAI) on Night 1 and Night 7(Nights 1 and 7)