Comparison of the Efficacy of Obstructive Sleep Apnea Treatment With CPAP With and Without the Use of Expiratory Pressure Relief Technology
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Peak Inspiratory Flow
研究概览
简要总结
Expiratory pressure relief (EPR) is a technology designed to improve patient comfort during continous positive airway pressure (CPAP) treatment for obstructive sleep apnea (OSA). The investigators hypothesized that the use of CPAP with EPR is less effective in controlling OSA when compared to CPAP without EPR, applied at the same treatment pressure. The investigators also hypothesized that the CPAP pressure necessary to abolish respiratory events during both manual and automatic CPAP titration with EPR will be greater than the pressure titrated with CPAP without EPR. OSA participants will undergo full polysomnography during CPAP and EPR will be turned on and off in order to test the impact of EPR on airflow and residual AHI.
详细描述
Participants will be recruited at the sleep clinic. The study will be carried out in 4 steps, the first 2 during one night of full polysomnography (PSG) and the last 2 during CPAP treatment for 4 weeks at home:
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PSG part 1: Intermittent application of expiratory pressure relief (EPR) during inspiratory flow limitation. Peak inspiratory flow will be measured with and without turning EPR technology on. 2) PSG part 2: After the intermittent application of EPR, polysomnography with manual CPAP titration will be performed with EPR technology on (CPAP-EPRon) and without EPR (CPAP-EPRoff), under random order and one blinded observer.
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CPAP: Use of outpatient CPAP, in random order, for a total of 3 weeks: i. adjusted to CPAP-EPRoff, without turning EPR on (1 week) and turning EPR on(1 week).
ii. adjusted to CPAP-EPRon, turning EPR on, for 1 week. 4) Use of outpatient CPAP, in random order, for a total of 2 weeks: i. adjusted in automatic mode without turning EPR on (1 week) and turning EPR on (1 week).
Before the start of step 1, participants will be assessed using questionnaires to assess excessive daytime sleepiness (Epworth Sleepiness Scale) and sleep quality (Pittsburgh Sleep Quality Index).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Participant Masking: on steps 2, 3 and 4 Investigator Masking: on step 2
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •both sexes
- •aged eighteen or over
- •already have baseline polysomnography showing a severe Apnea-Hypopnea Index (AIH), defined according to the current criteria of the American Academy of Sleep Medicine (AASM) as 30 events / hour of sleep or more
- •already be using a continuous positive pressure device (CPAP) at a pressure equal to or greater than 9 cmH2O with good adherence, defined as an average use equal to or greater than 4 hours per day.
排除标准
- •Patients with:
- •severe or decompensated respiratory or cardiac diseases
- •previous pharyngeal surgery or other sleep disorders, such as parasomnias, narcolepsy or primary insomnia
- •users of sedative medications such as opioids, benzodiazepines and muscle relaxants
- •uncontrolled diabetes or hyperthyroidism
研究组 & 干预措施
Polysomnographic night
intermittent application of the EPR technology on CPAP device during step 2, on polysomnographic night of the study.
干预措施: EPR (Device)
Outpatient CPAP use
Application of EPR technology during outpatient CPAP usage, on steps 3 and 4 of the study
干预措施: EPR (Device)
结局指标
主要结局
Peak Inspiratory Flow
时间窗: 1 day
The value of the peak inspiratory flow, measured before and after the activation of expiratory pressure relief technology, on a flow limitation period of sleep
Apnea and Hypopnea Index with CPAP on fixed mode
时间窗: 15 days, 5 days each group
The index of apnea and hypopnea measured with and without the expiratory pressure relief, measured with the titrated CPAP level, on fixed mode
Apnea and Hypopnea Index with CPAP on automatic mode
时间窗: 14 days, 7 days each group
The index of apnea and hypopnea measured with and without the expiratory pressure relief, with the titrated CPAP level, on automatic mode
Titrated CPAP level
时间窗: 1 day
The titrated CPAP level with and without the application of expiratory pressure relief technology
次要结局
- CPAP mask pressure(1 day)
- CPAP Leakage, with CPAP on fixed mode(15 days, 5 days each group)
- CPAP usage, with CPAP on fixed mode(15 days, 5 days each group)
- CPAP Leakage, with CPAP on automatic mode(14 days, 7 days each group)
- CPAP usage, with CPAP on automatic mode(15 days, 5 days each group)