Oventus ExVent Accessory to the O2Vent Optima Device
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in AHI between baseline AHI and the AHI measured during the in-lab PSG sleep night using the O2Vent Optima + ExVent.
研究概览
简要总结
The ExVent is an optional accessory to the O2Vent Optima MAD and provides oral Expiratory Positive Airway Pressure (EPAP). Oral EPAP with the ExVent is designed to provide upper airway support via similar mechanisms of action of nasal EPAP devices in commercial distribution, e.g., passive dilatation of the airway, which reduces flow limitation. Nasal EPAP devices are in commercial distribution as stand-alone therapies for the treatment of OSA. The oral EPAP provided by the ExVent accessory is designed to augment the OSA therapy provided by the O2Vent Optima.
详细描述
Title Use of the ExVent Accessory with the O2Vent Optima Oral Appliance for the Treatment of Obstructive Sleep Apnea
Investigational Device Oventus Medical ExVent Accessory (inserted into the O2Vent Optima device)
Investigator Study Sites Up to 3 investigational sites
Regulatory Status This is a non-significant risk investigational device exemption (IDE) clinical trial. FDA approval is not required, but IRB review and approval are required.
Study Design Prospective, open label, single-arm multicenter study Sample Size Up to thirty (30) subjects will be enrolled to yield a minimum of 20 evaluable subjects (mITT subjects).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 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
- •Male or female subject aged 22 years or older.
- •Subject completed a PSG study within the last 6 months at the investigational site's sleep lab and obtained a baseline AHI confirming a diagnosis of mild to moderate obstructive sleep apnea.
- •Subject (self-reports) that he/she is currently a compliant O2Vent Optima user (i.e., using the device for at least 4 hours/night for at least 5 nights/week).
- •Subject completed initial fitting optimization of the O2Vent Optima device.
- •Investigator has determined that the subject could abstain from use of the oral appliance or other sleep apnea therapies for up to 7 days.
- •Must be able to comply with all study requirements as outlined in the protocol.
排除标准
- •Inclusion Criteria:
- •Male or female subject aged 22 years or older.
- •Subject completed a PSG study within the last 6 months at the investigational site's sleep lab and obtained a baseline AHI confirming a diagnosis of mild to moderate obstructive sleep apnea.
- •Subject (self-reports) that he/she is currently a compliant O2Vent Optima user (i.e., using the device for at least 4 hours/night for at least 5 nights/week).
- •Subject completed initial fitting optimization of the O2Vent Optima device.
- •Investigator has determined that the subject could abstain from use of the oral appliance or other sleep apnea therapies for up to 7 days.
- •Must be able to comply with all study requirements as outlined in the protocol.
- •Exclusion Criteria:
- •Oral cavity infection or any other oral or dental condition or problem that would limit patient use of the O2Vent Optima oral appliance.
- •Any concomitant diagnosed or suspected sleep disorder including insomnia or central apnea.
- •History of any prior OSA surgical treatments including RF ablation treatment or palatal stent devices.
- •Concomitant use of any other prescription device for treatment of OSA.
- •Female of child-bearing age who is pregnant or intending to become pregnant during the study participation period.
- •Subject with significant change in weight since completion of the diagnostic baseline PSG study (i.e., ±10% or greater change in total body weight.
- •Subject on a non-stable dose of medications or other agents that may affect sleep and/or PSG (e.g., sedatives or hypnotics).
- •Subject who consumes > 500 mg caffeine per day (e.g., > 8 cola-type beverages, > 5 cups of coffee).
- •Subject who consumes > 3 alcoholic drinks/day.
- •Subject currently enrolled in any other research study.
结局指标
主要结局
Change in AHI between baseline AHI and the AHI measured during the in-lab PSG sleep night using the O2Vent Optima + ExVent.
时间窗: Two Years
To demonstrate that the ExVent Accessory (inserted into the O2Vent Optima device) is safe and effective in treating mild to moderate OSA. Statistically significant change in AHI with use of the O2Vent Optima + ExVent compared to baseline AHI value (i.e., no treatment).
次要结局
- Adverse events will be summarized descriptively in terms of type and frequency(Two years)
研究者
Sat Sharma
Investigator
Centre for Sleep and Chronobiology, Canada