A Randomized Crossover Study of Subjective Comfort With At-Home Auto-Titrating Positive Airway Pressure (APAP): 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
- Subjective comfort
研究概览
简要总结
The KPAP EPR Home is a randomized, crossover study in which subjective comfort will be compared between SleepRes APAP + KPAP and ResMed APAP + EPR. Participants will be individuals with newly diagnosed OSA who have not previously tried any PAP treatment (PAP-naïve).
Upon signing an informed consent, participants will be randomized to receiving either APAP + KPAP (delivered by a SleepRes device) or APAP + EPR (delivered by a ResMed device) for home use. Participants will be asked to use the devices (in the order of randomization) for 4 days each, with 3 days of washout in between. Participants will be blinded to the sequence order, even though they will receive machines that are not identical at each treatment. The KPAP drop will be set to the maximum level (i.e., 5 cmH2O), while EPR will be set on 3. APAP will be set on the full pressure range (i.e., 5-20 cmH2O). After each period, each individual will be asked to rate their device preference according to a 10-point visual analog (VAS) scale (i.e., 1=extremely uncomfortable treatment; 10=extremely comfortable treatment). After usage, the devices will be returned to the office and device data will be downloaded.
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)
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.
研究组 & 干预措施
APAP + KPAP
Auto-adjusting positive airway pressure + Kairos positive airway pressure
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
Subjective comfort
时间窗: This outcome will be evaluated after 4 days of treatment in each arm
This outcome will be evaluated through a 10 point Visual Analog Scale (VAS)
次要结局
- P95(This outcome will be evaluated after 4 days of treatment in each arm)
- Residual AHI(This outcome will be evaluated after 4 days of treatment in each arm)
- Adherence (in average h/night)(This outcome will be evaluated after 4 days of treatment in each arm)