Revised Algorithm for Next Generation DeVilbiss AutoAdjust CPAP
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- % Agreement Between Reviewer and Machine Pressure Settings During Sleep Study
研究概览
简要总结
The purpose of this protocol is to improve the current FDA-approved continuous positive pressure auto-titration algorithm, including treatment precision, residual disease detection characteristics and phenotyping with the DeVilbiss brand AutoAdjust CPAP device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Apnea hypopnea index ≥ 15 / hour of sleep on the diagnostic polysomnogram, or diagnostic component of a split night polysomnogram
- •Sleep efficiency reported on CPAP titration night PSG should be > 78%
- •Diagnosis of moderate to severe obstructive sleep apnea (AHI ≥15) or central/complex sleep apnea
- •On stable CPAP or APAP [Automatic Positive Airway Pressure] therapy, with compliant use averaging 4 or more hours nightly
- •Age 21-75 years
- •Predominately central sleep apnea for up to 10 subjects only
- •Willingness to give written informed consent and ability to adhere to visit schedule
排除标准
- •Diagnosis of mild sleep apnea
- •CPAP naïve patients
- •Co-morbid conditions which render participation to be at risk. These may include patients with congestive heart failure, COPD [Chronic Obstructive Pulmonary Disease] or psychiatric illness
- •Allergies to mask materials
- •Evidence of another primary sleep disorder
- •Evidence of arousing periodic limb movements during titration
- •Contraindications as listed on product labeling
- •Currently diagnosed with depression if symptomatic
- •Deemed medically unsuitable by investigator
- •Evidence of any type of infection or treatment of an infectious condition during the period of research participation
- •Have a bi-level requirement, or prescribed a bi-level therapy device
- •CPAP pressure >15cmH2O
- •Subjects with tracheotomy
- •Uncontrolled hypertension
- •Require supplemental oxygen
- •Stimulants, major tranquillizers or antipsychotics
- •Restless Leg Syndrome or Periodic Leg Movement Index of > 5 per hour
结局指标
主要结局
% Agreement Between Reviewer and Machine Pressure Settings During Sleep Study
时间窗: 1 night
The primary objective for the study was demonstrating effectiveness of therapy provided by the DeVilbiss AutoAdjust device as reported by the expert human reviewer. The primary endpoint was that expert human reviewer should agree with pressure changes made by the machine during each 20-minute epoch at least 80% of the time. Expert human reviewer reviewed each study and made a determination at 20-minute time points, in context of REM/NON-REM sleep and supine/non-supine positions, marking the machine pressure response with an "agree" or "disagree." Pressure changes might show no change, increase or decrease during the 20-minute epoch.
次要结局
未报告次要终点