Evaluation of APAP With SensAwake in OSA and Insomnia Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Objective Sleep Quality - Wake After Sleep Onset (WASO)
研究概览
简要总结
The hypothesis is that APAP with SensAwake improves wake-after sleep onset compared to APAP without SensAwake in a patient population with Obstructive Sleep Apnea Syndrome (OSAS) and Insomnia.
详细描述
Patients with OSA and Insomnia will be enrolled into this randomized study to receive treatment with APAP with and without SensAwake. Baseline data will be collected for one week prior to CPAP initiation, followed by two treatment periods on each study arm of four weeks each.
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
- •Older than 18 years of age.
- •Diagnosed with OSA and eligible for CPAP treatment under local requirements (AHI>30 with no more than 20% of central respiratory events)
- •Naïve to CPAP therapy, i.e. have not been prescribed, or used CPAP in the last 5 years.
- •Fluent in spoken and written French
排除标准
- •Significant uncontrolled cardiac disease, as per the principal investigator's discretion, and/or Left Ventricular Ejection Fraction (LVEF) < 45%
- •Co-existing lung disease, as per the principal investigator's discretion
- •Co-existing sleep disorder, such as predominant central sleep apnea
- •Previous or current diagnosis of sleep phase delay
- •Pregnancy
- •Participants that are unable or unwilling to give informed consent
- •Receiving cognitive behavioral therapy or other intervention to treat insomnia. Subjects may be using hypnotics, but there shall be no change in hypnotic use during the protocol or 4 weeks preceding enrolment into the study.
- •Diagnosed with clinical depression and/or currently using anti-depressants and/or anti-anxiolytics within the last 6 months.
- •Hospital Anxiety OR Depression score > 11
- •Participating in another research study for the duration of participation in this study. Participation in an observational study or genetic study is permitted at the discretion of the investigator.
- •Patient protected by the Law, under guardianship or curators, as defined in Public Health Code in articles from L1121-5 to L1121-
- •Patient not covered by a health insurance
研究组 & 干预措施
APAP with SensAwake
Auto CPAP with SensAwake turned on and set at a pressure of 4cmH2O. SensAwake is a pressure relief function that reduces the CPAP pressure on the transition from sleep to wake.
干预措施: APAP with SensAwake (Device)
APAP without SensAwake
Auto CPAP delivered from the ICON+ CPAP device.
干预措施: APAP (Device)
结局指标
主要结局
Objective Sleep Quality - Wake After Sleep Onset (WASO)
时间窗: Four weeks
Amount of time spent awake after sleep onset, as measured by actigraphy
次要结局
- Objective Sleep Quality - Sleep efficiency(Four weeks)
- Treatment compliance(Four weeks)
- Insomnia severity - Insomnia Severity Index(Four weeks)
- Blood pressure(24 hours)
- Daytime sleepiness - Epworth Sleepiness Score(Four weeks)
- Objective Sleep Quality - Total Sleep Time(Four weeks)
- Objective Sleep Quality - Sleep Onset Latency(Four weeks)
- Subjective sleep quality - Pittsburgh Sleep Quality Index(Four weeks)
- Quality of Life - Short Form 12(Four weeks)