Effects of Pressure Control Device (SensAwake™) on Obstructive Sleep Apnea (OSA) Patients Who Remove the Mask for Unknown Reasons During Automatic Continuous Positive Airway Pressure (Auto-CPAP) Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 主要终点
- Compliance of Auto-CPAP Therapy
研究概览
简要总结
This study will investigate Obstructive Sleep Apnea (OSA) and an automatically Adjusting Positive Airway Pressure (APAP) device with new technology called SensAwake™. This requires experimental confirmation in a randomised controlled trial with crossover design, comparing compliance on standard APAP with compliance using APAP modified by the addition of the SensAwake™ modification on consecutive nights in participants with moderate-to-severe OSA.
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, Investigator)
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
- •Participants will be recruited from OSA patients who will remove CPAP himself without any notable reasons.
排除标准
- •Unstable cardiovascular disease (untreated or resistant hypertension acceptable).
- •Inability to tolerate CPAP due to nasal obstruction or claustrophobia as determined by the study investigator.
- •Any known factor or disease that might interfere with treatment compliance, study conduct or interpretation of the results such as psychiatric disease, history of non compliance to medical regimens, or unwillingness to comply with study requirements.
- •Any known factor that result in mask taken of such as skin discomfort, nasal obstruction, water dripping inside the tubing system etc.
研究组 & 干预措施
APAP begins without SensAwake
Patients will receive CPAP treatment without SensAwake™ activation for two weeks, then crossed-over to CPAP treatment with SensAwake™ activation for additional two weeks.
APAP begins with SensAwake
Patients will receive CPAP treatment with SensAwake™ activation for two weeks, then crossed-over to CPAP treatment without SensAwake™ activation for additional two weeks.
SensAwake™ modification: SensAwake™ is a new design based on the research of Doctor Ayappa 5 years ago. The SensAwake™ modification to the Fisher and Paykel automatically titrating positive airway pressure (APAP) device aims to sense whether the patient is awake via respiratory patterns that differentiate between sleep and wake. Upon sensing that the patient is awake the device is able to reduce positive airway pressure PAP aiming to improve patient comfort which should result in more consolidated sleep.
干预措施: SensAwake™ modification (Device)
结局指标
主要结局
Compliance of Auto-CPAP Therapy
时间窗: 2 weeks
Objective data recorded in the auto-CPAP machine, Percentage of nights of using auto-CPAP for at least 4 hours during therapy.
次要结局
- 90th Percentile Pressures of Auto-CPAP Machine(2 weeks)
- Time Used of Auto-CPAP Machine(2 weeks)
- Average SA Detections(2 weeks)
- Average Leaks of Auto-CPAP Machine(2 weeks)
- 90th Percentile Leaks of Auto-CPAP Machine(2 weeks)
- Average Pressures of Auto-CPAP Machine(2 weeks)
- Pittsburgh Sleep Quality Index (PSQI)(2 weeks)
- Nasal Obstruction Symptom Evaluation (NOSE)(2 weeks)
- Residual Apnea-Hypopnea Index (AHI)(2 weeks)
- Percentage of Day Used of Auto-CPAP Machine(2 weeks)
- Epworth Sleepiness Score (ESS)(2 weeks)