Feasibility of a Modified Positive Airway Pressure Device to Treat Sleep Disordered Breathing
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Apnea hypopnea index (AHI)
研究概览
简要总结
This study will use a modified version of a positive airway pressure device to supply air to the participant, while undergoing supervised polysomnography. Positive airway pressures are typically applied to many patients with hypoventilation, in this study these pressures will be titrated by a qualified sleep technician. During the night these pressures will be altered to optimise comfort.
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
- •Patients diagnosed with obesity hypoventilation syndrome (OHS) and/or obstructive sleep apnea (OSA) by a practicing sleep or respiratory physician, requiring positive airway pressure (PAP) therapy
排除标准
- •Recent cardiac or respiratory arrest
- •Gastro intestinal bleeding, ileus or recent gastrointestinal surgery
- •Coma, decreased level of consciousness or agitation
- •Anatomical or subjective difficulty with airway access e.g. facial surgery, trauma, vomiting upper airway obstruction
- •Cerebrospinal fluid leak, abnormalities of the cribiform plate or prior history of head trauma.
研究组 & 干预措施
Positive airway pressure (PAP) device
Fisher & Paykel Healthcare PAP Device. Participants will sleep overnight using themodified positive airway pressure device. Their pressures will be titrated by a qualified sleep technician, they will then be optimised during the night.
干预措施: Fisher & Paykel Healthcare PAP Device (Device)
结局指标
主要结局
Apnea hypopnea index (AHI)
时间窗: 8 hours
The number of apnea and hypopneas will be measured
Peripheral blood oxygen level (SpO2)
时间窗: 8 hours
Peripheral blood oxygen level will be measured
次要结局
未报告次要终点