Comparison Study Using APAP With and Without SensAwake in Patients With OSA and PTSD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- Adherence (Hours on Therapy)
研究概览
简要总结
The purpose of this research is to examine the application of AutoCPAP with and without SensAwake in subjects with OSA and Post-Traumatic Stress Disorder (PTSD), and evaluate whether patients achieve better sleep quality and compliance with SensAwake, compared to the same treatment without SensAwake.
详细描述
Conceptually, awareness of pressure occurs only during wakefulness. Thus reducing the pressure during wakefulness may improve therapy comfort and potentially adherence without compromising therapy efficacy. SensAwake™ is a unique pressure relief technology developed by Fisher & Paykel Healthcare which detects irregularity in the flow signal indicative of the transition from sleep to wake. When the transition from sleep to wake is detected the device promptly reduces the pressure to help facilitate a return to sleep.
It is hypothesised that AutoCPAP with SensAwake will improve patient comfort and compliance in the PTSD and OSA patients who are naïve to CPAP therapy.
The investigators will not be blinded to the study. The participants will be blinded to the study.
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 (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
- •Male and female subjects > 18 years Diagnosed with OSA by a practicing sleep physician, within the last six months Diagnosed with post-traumatic stress disorder as diagnosed by a behavioral health professional, and quantified by McChord PTSD checklist All races and ethnicities will be included Naïve to CPAP therapy (has not used CPAP within the last 5 years)
排除标准
- •< 18 years of age if mental status is questionable, the patient will be excluded at the discretion of the consenting provider Unable/unwilling to follow the directions necessary for CPAP use Patients contraindicated for CPAP/AutoCPAP, at the discretion of the consenting provider
研究组 & 干预措施
AutoCPAP with SensAwake Off, then SensAwake On
Participants will start AutoCPAP treatment with SensAwake Off for 4 weeks. After 4 weeks, the will cross over to SensAwake On for another 4 weeks.
干预措施: AutoCPAP with SensAwake On (Device)
AutoCPAP with SensAwake Off, then SensAwake On
Participants will start AutoCPAP treatment with SensAwake Off for 4 weeks. After 4 weeks, the will cross over to SensAwake On for another 4 weeks.
干预措施: AutoCPAP with SensAwake Off (Device)
AutoCPAP with SensAwake On, then SenAwake Off
Participants will start AutoCPAP treatment with SensAwake on for 4 weeks. After 4 weeks, the will cross over to SensAwake off for another 4 weeks.
干预措施: AutoCPAP with SensAwake On (Device)
AutoCPAP with SensAwake On, then SenAwake Off
Participants will start AutoCPAP treatment with SensAwake on for 4 weeks. After 4 weeks, the will cross over to SensAwake off for another 4 weeks.
干预措施: AutoCPAP with SensAwake Off (Device)
结局指标
主要结局
Adherence (Hours on Therapy)
时间窗: 4 weeks
Hours per night averaged over total time period measured.
次要结局
- Sleep Quality (Epworth Sleepiness Scale (ESS)(Change from Baseline after 4 weeks)
- Insomnia Severity Index (ISI)(Change from Baseline after 4 weeks)