Clinical Study for the BONGO Device in the Treatment of Obstructive Sleep Apnea
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Change in Apnea-Hypopnea Index (AHI)
研究概览
简要总结
Prospective, non-randomized, open label study
详细描述
This study is a prospective, non-randomized, open label, single-center clinical study for the BONGO NASAL device for the treatment of obstructive sleep apnea. The study consists of two in laboratory polysomnographic studies and a one two week in home period.
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 with the 3% hypopnea criteria
- •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)
研究组 & 干预措施
BONGO DEVICE
All participants that qualify will receive the intervention of the Bongo device
干预措施: BONGO DEVICE (Device)
结局指标
主要结局
Change in Apnea-Hypopnea Index (AHI)
时间窗: At Diagnostic Baseline PSG and at Final Treatment PSG with the device
Obstructive Sleep Apnea (OSA) severity is divided into three categories based on the Apnea-Hypopnea Index (AHI) as follows: Mild (AHI of 5 to 15), Moderate (AHI of 15 to 30), and Severe (AHI \> 30). AHI is calculated by dividing the number of events (i.e. Apneas and hypopneas) by the number of hours of sleep. The primary outcome for the study was change in AHI, defined as the difference in AHI between the diagnostic PSG study (baseline with no device) and the final PSG study with the Bongo device for the subjects that completed the entire study.
次要结局
未报告次要终点