Transcend Auto vs Commercially Available Device Clinical Evaluation for Treatment of Obstructive Sleep Apnea (OSA)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 3
- 主要终点
- Mean Apnea Hypopnea Index (AHI) During Treatment
研究概览
简要总结
The purpose of this study is to determine whether the Transcend Auto is as effective in treating obstructive sleep apnea as another device that is already on the market.
详细描述
This is a prospective, randomized, crossover trial. Patients will be randomized 1:1 to undergo two full night sleep studies with the Transcend Auto and a commercially available device.
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)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult 18 years of age or older
- •Diagnosis of obstructive sleep apnea
- •Presently using CPAP or APAP therapy
排除标准
- •Central or mixed apnea
研究组 & 干预措施
Transcend followed by REMstar
The patient will receive treatment with Transcend during the first night sleep study, followed by treatment with the REMstar on the second night.
干预措施: Somnetics Transcend Auto (Device)
Transcend followed by REMstar
The patient will receive treatment with Transcend during the first night sleep study, followed by treatment with the REMstar on the second night.
干预措施: Respironics REMstar Auto with C-Flex (Device)
REMstar followed by Transcend
The patient will receive treatment with REMstar during the first night sleep study followed by treatment with Transcend on the second night.
干预措施: Somnetics Transcend Auto (Device)
REMstar followed by Transcend
The patient will receive treatment with REMstar during the first night sleep study followed by treatment with Transcend on the second night.
干预措施: Respironics REMstar Auto with C-Flex (Device)
结局指标
主要结局
Mean Apnea Hypopnea Index (AHI) During Treatment
时间窗: first and second night sleep study
Apnea hypopnea index (AHI) will be measured during treatment with each of the devices. AHI = (number of apneas + number of hypopneas) / total sleep time in hours. The minimum score is zero. The higher the score, the more severe the sleep apnea. For example, obstructive sleep apnea is defined as an AHI \>/= 15. AHI was measured by the devices and independently by a central laboratory.
次要结局
- Unanticipated Adverse Device Effects(first and second night sleep study)
- Mean Differences Between Polysomnography (PSG) and Device Measures of Apnea Index (AI) and Hypopnea Index (HI)(first and second night sleep study)