Comparison Study of the ICON™ Auto Series With and Without SensAwake™ and ThermoSmart™ and Conventional Continuous Positive Airway Pressure in Obstructive Sleep Apnea Patients
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Adherence With Treatment Per Night Averaged Over Total Time Period Measured Via Internal Software on the Device and Reported on Using InfoSmart™ Software.
研究概览
简要总结
A total of 216 patients will be randomized into a partially single blind, randomized, parallel-arm trial to determine whether the ICON™ AT with SensAwake™ and ThermoSmart™ can improve therapy adherence when compared to standard care with a fixed pressure Continuous Positive Airway Pressure (CPAP) device and compared to a less aesthetically pleasing CPAP device without technologies (AutoCPAP, SensAwake™, ThermoSmart™) in patients previously diagnosed with moderate-severe obstructive sleep apnea (OSA).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-70 years with moderate-to-severe OSA (Apnea Hypopnea Index equal to or greater than 10 per hour).
- •Successful titration Polysomnography (PSG).
- •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.
- •Previous surgery for OSA or snoring or any surgery of the mouth, nose, sinuses or airways.
- •If SensAwake™ or ThermoSmart™ was disabled on the treatment arm (or conversely) during the study protocol.
- •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.
研究组 & 干预措施
Conventional CPAP
Fisher & Paykel HC244™
干预措施: Conventional CPAP Therapy (Device)
CPAP without Humidification
Fixed pressure ICON™ without ThermoSmart™
干预措施: Fixed pressure ICON™ without ThermoSmart™ (Device)
APAP with all technologies
Auto ICON™ with SensAwake™ and ThermoSmart™
干预措施: Auto ICON™ with SensAwake™ and ThermoSmart™ (Device)
结局指标
主要结局
Adherence With Treatment Per Night Averaged Over Total Time Period Measured Via Internal Software on the Device and Reported on Using InfoSmart™ Software.
时间窗: On day 90 after randomization
次要结局
- Adherence (Hours of Usage Per Night) and Acceptance (Number of Drop-outs). Complaints During Follow up Calls and Visit.(On day 90 after randomization)