Validation of Customer Requirements for the HC244/HC254
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Apnea Hypopnea Index (AHI)
研究概览
简要总结
This study is designed to determine the effectiveness of two different CPAP devices. One a standard CPAP which has the ability to store comprehensive compliance and efficacy data and the second a auto adjusting CPAP which uses the energy spectrum analysis of flow signals to automatically adjust CPAP pressure and improve sleep variables.
详细描述
All patients with suspected obstructive sleep apnea presenting at the Auckland Hospital Sleep Laboratory and referred for either a split-night or full night diagnostic study, will be offered participation in the study and will be recruited. From these patients, a total of 20 patients that are diagnosed with clinical obstructive sleep apnea syndrome, based on diagnostic polysomnography, will undergo titration with the HC254 Auto CPAP. An additional 20 patients will undergo titration with the HC244 CPAP.
The sleep physiologist evaluating the patient clinically will approach patients for participation in this study during their sleep laboratory visit. Consenting patients will undergo either an initial full night diagnostic polysomnography or a split night study as determined by the physician based on clinical requirements. Patients diagnosed with obstructive sleep apnea (AHI > 15/hr) during this diagnostic component will then undergo one of the following:
- Treatment with the HC254 Auto CPAP during the second half of the study.
- Treatment with the HC244 CPAP during the second half of the study.
The sleep physiologist will then determine final CPAP prescriptions for all patients based on the patient's response to CPAP therapy.
5 subjects who have completed the HC254 arm of the study will be brought back to the sleep lab for an additional PSG or partial PSG while on CPAP pressure set to 90th percentile pressure determined on the diagnostic night.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusions criteria:
- •AHI > 15 on the diagnostic night or portion of the split night study.
- •≥18yrs of age
排除标准
- •Significant Central Apnea
- •Co-existing obesity related hypoventilation
- •Inability to give informed consent
- •Patient intolerance to CPAP
- •Anatomical or physiological conditions making CPAP therapy inappropriate.
- •Less than 3 hours in the titration period
- •Under Land Transport New Zealand (LTNZ) investigation
结局指标
主要结局
Apnea Hypopnea Index (AHI)
时间窗: At the end of the sleep study
次要结局
未报告次要终点