Comparison Study of the ICON™ CPAP Series With and Without SensAwake™
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 4
- 主要终点
- Adherence to CPAP Treatment
研究概览
简要总结
Conceptually, awareness of pressure occurs only during wakefulness. Thus reducing the pressure during wakefulness may improve therapy comfort and potentially adherence without compromizing 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.
The purpose of this study is to compare adherence and sleep quality outcomes in patients treated by CPAP with and without SensAwake technology.
It is hypothesised that participants with SensAwake on will have improved adherence and sleep quality.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-75 years with moderate-to-severe OSA (AHI equal to or greater than 10 per hour).
- •Successful in-lab titration polysomnography (PSG)
- •General (at home) sleep habits of:
- •At least 7 hours in bed on most nights
- •Lights out at 12 midnight or earlier
- •Fluency in both written and spoken English.
排除标准
- •Participants prescribed and fitted with any PAP device in the past 2 years
- •Contraindicated for CPAP or AutoCPAP therapy.
- •Any known factor or disease that might interfere with treatment adherence, study conduct or interpretation of the results such as severe psychiatric disease, history of non adherence to medical regimens, or unwillingness to comply with study requirements as determined by the principal investigator.
- •Other significant sleep disorder(s) that would interfere with their ability to wear CPAP as determined by the principal investigator.
- •Patients who are prescribed hypnotics and sedating medications.
- •Any surgery of the mouth, nose, sinuses or airways (for OSA, snoring or otherwise) in the past 12 months.
- •If participants are required, by the nature of their employment, to comply with therapy. For example truck drivers or airline pilots.
- •If the physician objects to their patient taking part in the study.
结局指标
主要结局
Adherence to CPAP Treatment
时间窗: 2 weeks
Average used minutes (all days) taken from the CPAP device.
次要结局
- OSA Impact of Daily Life(4 weeks)
- OSA Impact of Daily Life (Fatigue)(4 weeks)
- Daytime Sleepiness (Subjective Sleep Quality)(4 weeks)
- Insomnia Severity Index (Subjective Sleep Quality)(4 weeks)
- Subjective Treatment Efficacy - Patient Global Impression of Change (PGI) - Change(4 weeks)
- Subjective Treatment Efficacy - Patient Global Impression of Change (PGI) - Severity(4 weeks)