NCT03999944已完成不适用
Non-Inferiority Study of the FRESCA Airbox Positive Airway Pressure System Versus the (Predicate) FRESCA Positive Airway Pressure System for the Treatment of Obstructive Sleep Apnea
FRESCA Medical11 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2019年10月14日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 11
- 主要终点
- Apnea-Hypopnea Index (AHI)
研究概览
简要总结
Prospective, open-label, randomized crossover assignment, multi-center non-inferiority study conducted in the United States
详细描述
This study is designed to demonstrate that the FRESCA Airbox Positive Airway Pressure System is non-inferior to the existing FRESCA Positive Airway Pressure System. Subjects meeting the inclusion and exclusion criteria will be randomized to one sleep night with the existing FRESCA device programmed to fixed pressure and one sleep night with the investigational FRESCA device programmed to auto-adjusting pressure and exhale pressure relief.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Central sleep study scorer will be masked to assignment group
入排标准
- 年龄范围
- 22 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged 22 - 75 years old.
- •BMI: ≤ 40 kg/m
- •Subjects diagnosed with OSA (either newly diagnosed (naive) OSA subjects or current CPAP subjects).
- •Must be able to be fitted properly with FRESCA mask.
- •Must be able to comply with all study requirements as outlined in the protocol.
- •Subject must complete a valid PSG titration night.
排除标准
- •Subjects with non-OSA sleep disorders (including periodic limb movement (PLM) disorder and chronic insomnia).
- •Subjects with substantial central or mixed apneas (central and mixed apnea ≥ 5/hr.).
- •Subjects with prior surgical intervention for OSA.
- •Subjects with frequent or sustained episodes of O2 saturation ≤75%.
- •Subjects with obesity-related hypoventilation.
- •Subjects currently using a CPAP full face mask.
- •Subjects who are medically unstable.
- •Subjects with unstable or severe cardiovascular abnormalities (e.g., heart failure, valvular heart disease).
- •Subjects with atrial fibrillation or other arrhythmias that are not effectively controlled with medication.
- •Subjects with hypotension or uncontrolled HTN.
- •Subjects with chronic lung disease, including COPD.
- •Subjects with significant cardiopulmonary disease.
- •Subjects with ongoing severe nasal allergies or sinusitis or difficulty breathing through the nose; persistent blockage of one or both nostrils; or any nasal or facial abnormalities that would not allow adequate placement and use of the mask.
- •Subjects with surgery of the upper airway, nose, sinus or middle ear within the previous year.
- •Subjects currently working nights, rotating night shifts or with planned travel during the study period.
- •Subjects on a non-stable dose of medications or other agents that may affect sleep and/or PSG (e.g., sedatives or hypnotics).
- •Subjects who consume > 500 mg caffeine per day (e.g., > 8 cola-type beverages, > 5 cups of coffee).
- •Subjects who consume > 14 alcoholic drinks/week.
- •Subjects who are pregnant (confirmed verbally).
- •Subjects currently enrolled in any other research study.
结局指标
主要结局
Apnea-Hypopnea Index (AHI)
时间窗: 1 sleep night
The mean combined number of apnea and hypopnea events per hour of sleep
次要结局
- Oxygen Desaturation Index (ODI)(1 sleep night)
研究者
研究点 (11)
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