A Randomized Crossover Study of Continuous Positive Airway Pressure (CPAP) Treatment Efficacy: Kairos PAP (KPAP) Versus Expiratory Pressure Relief (EPR)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 24
- 主要终点
- Treatment efficacy
研究概览
简要总结
The KPAP EPR is a randomized, crossover study in which treatment efficacy will be compared between SleepRes CPAP + KPAP and ResMed CPAP + EPR. Participants will be chosen from those with a recent OSA diagnosis (following an in-lab polysomnogram, a split-night study or a home sleep apnea test) and with no previous use of OS therapy (PAP-naïve).
Upon signing an informed consent, participants will be scheduled to come to the sleep laboratory for a manual titration on CPAP. Once the therapeutic pressure is determined, participants will be randomized to start either CPAP + KPAP (delivered by a SleepRes device) or CPAP + EPR (delivered by a ResMed device). Participants will be blinded to the sequence order. They will then be invited to the laboratory for two overnight sleep studies, one on each treatment device, in the order determined by the randomization, with a minimum washout of 1 week and a maximum of 3 weeks. Both studies will use the therapeutic pressure determined during manual titration. The KPAP drop will be set to the maximum level (i.e., 5 cmH2O), while EPR will be set on 3. The next morning of each sleep study, participants will be administered visual analog scale (VAS) questionnaires to examine subjective sleep quality (1=best sleep quality; 10=worst sleep quality) and, after all studies are completed a device subjective preference (1=CPAP+KPAP was extremely better than CPAP+EPR; 10=the opposite).
The study will be single blinded with both the participants (the device will be concealed in the laboratory so that participants will not be able to understand what treatment they are on) and the registered technician scoring the polysomnographies blinded to treatment allocation.
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)
盲法说明
Also the scorer of the studies will be blinded to treatment allocation
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI above 18 kg/m2, inclusive
- •Recent formal diagnosis of OSA meeting all the following criteria: AHI > 10, Central apneas < 25% of events, PLM arousal index < 15, no prior/concomitant OSA therapy
- •Subject is fluent in English and subject understands the study protocol and is willing and able to comply with study requirements and sign informed consent.
- •Participant voluntarily agrees to participate in this study and signs an Institutional Review Board (IRB)-approved informed consent prior to performing any of the study-related procedures.
排除标准
- •A female of child-bearing potential that is pregnant or intends to become pregnant.
- •Any unstable or severe medical condition of any organ system including congestive heart failure, COPD, renal failure, neuromuscular disease, etc., or at the discretion of the site Principal Investigator (PI).
- •Taking medication that may affect sleep, sleepiness, or alertness including hypnotics, sedatives, alerting agents, stimulants, anticonvulsants, etc.
- •The presence of any other sleep disorder (insomnia, periodic limb movement disorder, etc.).
- •The presence of a psychiatric disorder, including attempted suicide within 1 year prior to screening, or current suicidal ideation.
- •A serious illness or infection in the past 30 days.
- •Excessive alcohol consumption (>21 drinks/week).
- •The use of any illegal drug(s).
- •Any condition that in the investigator's opinion would present an unreasonable risk to the participant, or which would interfere with their participation in the study or confound study interpretation.
- •Chronic nocturnal oxygen therapy.
- •Active hypoglossal nerve stimulation implant.
研究组 & 干预措施
APAP + KPAP
Auto-adjusting positive airway pressure + Kairos PAP
干预措施: APAP + KPAP (Device)
APAP + EPR
Auto-adjusting positive airway pressure + Expiratory Pressure Relief
干预措施: APAP + EPR (Device)
结局指标
主要结局
Treatment efficacy
时间窗: This outcome will be evaluated after one night of treatment
Per residual apnea hypopnea index determined through an in-laboratory polysomnography
次要结局
- Leak(This outcome will be evaluated after one night of treatment)
- Next-morning subjective sleep quality(This outcome will be evaluated after one night of treatment)
- Next-morning subjective device preference(This outcome will be evaluated after one night of treatment)
- Sleep onset latency(This outcome will be evaluated after one night of treatment)
- Total sleep time(This outcome will be evaluated after one night of treatment)
- Sleep efficiency(This outcome will be evaluated after one night of treatment)