NCT02590159终止不适用
Clinical Study for the BONGO NASAL EPAP Device in the Treatment of Obstructive Sleep Apnea (OSA)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Apnea Hypopnea Index
研究概览
简要总结
Single center clinical study for the BONGO NASAL EPAP device in the treatment of obstructive sleep apnea for the purpose of obtaining safety and efficacy data
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Capacity and willingness to sign informed consent
- •≥ 21 years of age
- •Diagnosis of mild to moderate OSA (AHI ≥ 5 and AHI < 30) within 12 months of the screening visit.
- •Able to tolerate using the device during a day time trial/acclimation
- •Are currently using CPAP or have been prescribed CPAP and are considered CPAP non-adherent (as per either their CPAP data card and/or verbal confirmation of a diagnosis and unwillingness to use CPAP)
排除标准
- •Nasal deformities
- •Severe nasal allergies
- •Rhinitis or moderate nasal congestion, acute upper respiratory (including nasal, sinus or middle ear) inflammation or infection, or perforation of the ear drum
- •Co-morbid sleep disorders
- •Currently on a hypnotic for insomnia (who have had insomnia for more than a month and take a hypnotic on a daily basis and/or transient insomnia being treated)
- •Uncontrolled or serious illness, including but not limited to: severe breathing disorders including hypercapnic respiratory failure, respiratory muscle weakness, bullous lung disease (as seen in some types of emphysema), bypassed upper airway, pneumothorax, pneumomediastinum, etc.; severe heart disease (including heart failure); or pathologically low blood pressure.
- •Full Face Mask user
- •Mouth breather
- •Pregnant (Female subjects of child bearing age will be asked if they are and/or planning on becoming pregnant during the study; acceptable methods of birth control include birth control pills and barrier method)
结局指标
主要结局
Apnea Hypopnea Index
时间窗: 2 weeks
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
A Disposable Device NAS to Treat Obstructive Sleep Apnea and SnoringObstructive Sleep ApneaSnoringNCT02928770Stanford University32
已完成
不适用
Face of SleepinessObstructive Sleep ApneaNCT01060436University of Michigan30
已完成
2 期
Obstructive Sleep Apnea (OSA) Treated With a Potassium Channel InhibitorSleep Apnea, ObstructiveNCT03603678Bayer34
已完成
不适用
Baseline Sleep Apnea Study #2Obstructive Sleep Apnea of AdultNCT04599803Verily Life Sciences LLC187
招募中
不适用
Sleep Apnea in Paralympic Ontario-Resident aThletes With Spinal Cord Injury (SPORTS) StudySleep ApneaBreathing Disorder During SleepingSleep DisorderSpinal Cord InjuriesSpine DiseaseNCT06195878University Health Network, Toronto15