Therapeutic Efficacy Evaluation of the CPAP/autoCPAP Sandman in the Treatment of New Patients With Obstructive Sleep Apnoea Syndrome
试验速览
- 阶段
- 3 期
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- To determine the sensitivity and specificity of the CPAP/autoCPAP Sandman in adequately detecting respiratory events and to evaluate the therapeutic effectiveness of the device in improving sleep quality and normalizing respiratory events
研究概览
简要总结
The study is a prospective field evaluation to assess the therapeutic value of the CPAP/autoCPAP Sandman in 24 new diagnosed Obstructive Sleep Apneic patients.
Precisely, the study was designed to :
- evaluate the therapeutic efficacy of the CPAP/autoCPAP Sandman device in improving sleep quality and normalozing respiratory events
- determine the sensitivity and specificity of the device in adequately detecting respiratroy events
- compare effective pressure Peff determined by the device and during manual titration
- compare the impact of the two-speed descent pressure algorithm
详细描述
During the study, each patient underwent one night of full polysomnography with two consecutives therapeutic sequences during the same night, after randomization of the passage order:
- autotitrating pressure phase: sleep parameters and respiratory events vs results of the polysomnographic registration,
- manual titration phase: concordance between events respiratory analyzed on the polysomnographic recordings and the events detected by the CPAP / auto-CPAP.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patient male or female, aged 18 to 75 years
- •weight > 30kg
- •patient with a newly diagnosed OSAS, under treatment with CPAP
- •patient in stable condition
- •patient affiliated to a social security insurance
- •having given its written informed consent to participate to the study
排除标准
- •pneumothorax or pneumomediastin history
- •massive epistaxis (current or previous)
- •decompensated heart failure or hypotension
- •pneumoencephal history, recent trauma or surgery sequel with cranio-nasopharyngeal fistula
- •acute sinusitis history, middle ear infection or perforation of the tympanic membrane
- •respiratory insufficiency or severe respiratory illness with the possibility of residual hypoxemia
- •severe bullous emphysema or previously complicated pneumothorax
- •severe claustrophobia
研究组 & 干预措施
A
Phase 1 : manual Phase 2 : automatic Descent rate pressure : slow
干预措施: titration night (Device)
B
Phase 1 : manual Phase 2 : automatic Descent Rate Pressure : fast
干预措施: titration night (Device)
C
Phase 1 : automatic Phase 2 : manual Descent rate pressure : slow
干预措施: titration night (Device)
D
Phase 1 : automatic Phase 2 : manual Descent Rate Pressure : fast
干预措施: titration night (Device)
结局指标
主要结局
To determine the sensitivity and specificity of the CPAP/autoCPAP Sandman in adequately detecting respiratory events and to evaluate the therapeutic effectiveness of the device in improving sleep quality and normalizing respiratory events
时间窗: May 2008
次要结局
- To compare effective pressure Peff determined by the device and during manual titration(May 2008)
- To compare the impact of the two-speed descent pressure algorithm(May 2008)