The Efficacy of a New Mathematical Formula to Predict Continuous Positive Air Pressure With an Oronasal Mask Interface.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Change in Severity of Sleep Apnea as Measured by the AHI
研究概览
简要总结
Subjects will all have a two week baseline period in which they will use a nasal mask using an air view CPAP machine (which records all data). After the two week period all will switch to a full face mask with half using the same CPAP pressure and half with a new a CPAP pressure derived from our formula for the final two weeks.
详细描述
The goal of this study is to test the efficacy of an algorithm the investigators previously created to adjust Continuous positive airway pressure (CPAP) when a mask interface is switched from a nasal to a full face.
Subjects will currently have a moderate to severe Apnea-hypopnea index (AHI - The Apnea-Hypopnea Index or Apnoea-Hypopnoea Index (AHI) is an index used to indicate the severity of sleep apnea. It is represented by the number of apnea and hypopnea events per hour of sleep). (above 15)
- Scoring of apneas Score a respiratory event as an apnea when BOTH of the following criteria are met: N1, N2, N3, N4
- There is a drop in the peak signal excursion by ≥90% of pre-event baseline using an oronasal thermal sensor (diagnostic study), PAP device flow (titration study) or an alternative apnea sensor (diagnostic study)
- The duration of the ≥90% drop in sensor signal is ≥ 10 seconds. Score an apnea as obstructive if it meets apnea criteria and is associated with absent inspiratory effort throughout the entire period of absent airflow.
Score an apnea as central if it meets apnea criteria and is associated with absent inspiratory effort throughout the entire period of absent airflow.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
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
- •AHI above
- •Willing to switch to full face mask post titration.
- •Not currently on a weight loss plan and no intention of beginning a weight loss regimen during the duration of the study
排除标准
- •AHI below
- •Not willing to switch to full face mask post titration.
- •Currently on a weight loss plan and / or intention of beginning a weight loss regimen during the duration of the study.
结局指标
主要结局
Change in Severity of Sleep Apnea as Measured by the AHI
时间窗: After a 2-week baseline period (for weeks 3 & 4), subjects will be switched from a nasal to full-face CPAP mask interface for two-weeks with either the same CPAP setting (control) or a new formula determined pressure (treatment).
The investigators will compare the Apnoea-Hypopnoea Index (AHI) of subjects with the new formula in place vs. those that don't have the formula. The Apnea-Hypopnea Index is an index used to indicate the severity of sleep apnea. It is represented by the number of apnea and hypopnea events per hour of sleep. A respiratory event is scored as an apnea when both of the following criteria are met: N1, N2, N3, N4. a) There is a drop in the peak signal excursion by greater than or equal to 90% of pre-event baseline using an oronasal thermal sensor (diagnostic study), PAP device flow (titration study) or an alternative apnea sensor (diagnostic study) b) The duration of the greater than or equal to 90% drop in sensor signal is greater than or equal to 10 seconds.
次要结局
- Lowest Oxyhemoglobin Saturation(One month)