Evaluation of the Efficacy of Sleepinnov© (Spiri+) Continuous Positive Airway Pressure Device
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Part 1: Validation of algorithm detection of respiratory events
研究概览
简要总结
Continuous Positive Airway Pressure (CPAP) is the reference treatment of patients suffering from Obstructive Sleep Apnea Syndrome (OSAS).This device functions as a pneumatic stent that stabilizes the upper airway, prevents periodic collapses during sleep.The correction of abnormal respiratory events during sleep allows improvement of symptoms related to OSAS and restores quality of life.The purpose of this study is to validate the efficacy of a new CPAP brand developed by Sleepinnov©.
详细描述
Obstructive sleep apnea syndrome (OSAS) is characterized by the repetitive occurrence of partial or complete pharyngeal obstructions during sleep.Continuous Positive Airway Pressure (CPAP) is the first line treatment of OSAS.
The aim of the prospective monocentric two steps pilot study SPIRI+ is to validate the efficacy of a new CPAP brand developed by Sleepinnov©.
- the first step will validate the capability of the algorithm to appropriately detect of abnormal repiratory events during sleep.the metrics will be a comparison of the total number of events detected by the CPAP Sleepinnov© with data arising from a concurrent polysomnography.
- the second step will check overall clinical efficacy of the new CPAP device by assessing the percentage of OSAS with an index of residual events below 10 and 5 per hour.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •newly diagnosed and untreated Obstructive sleep apnea syndrome (IAH >15/hour) with an indication of treatment with CPAP
- •Patients who have given their informed written consent
排除标准
- •Pregnant or lactating women
- •Patients not affiliated to the French social security system or equivalent
- •Patient deprived of liberty by judicial or administrative decision
- •Patients under guardianship or curatorship
结局指标
主要结局
Part 1: Validation of algorithm detection of respiratory events
时间窗: baseline
Comparison of the total number of events detected by the CPAP Sleepinnov© with data arising from a concurrent polysomnography.
Part 2: Validation of overall clinical efficacy
时间窗: baseline
Percentage of OSAS with an index of residual events below 10 and 5 per hour
次要结局
- Part 1:(baseline)