Decrease in Sympathetic Tone in OSA Patients: Is CPAP More Effective Than APAP ?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 57
- 试验地点
- 2
- 主要终点
- Sympathetic tone (MSNA)
研究概览
简要总结
The present study aims to compare muscle sympathetic neural activity by microneurography after one month treatment of fixed versus auto-adjusting CPAP treatment and its impact on arterial blood pressure
详细描述
Background: Sleep apnea syndrome (SAS) currently affects 10% of general population. It is characterized by the occurrence during the sleep of the upper airways closure which cause repeated asphyxia. It is a public health problem due to its cardiometabolic complications. Indeed, the absence of SAS treatment increases cardiovascular mortality by 12% at 10 years.
The main physiopathological mechanism is the activation of cardiovascular sympathetic control (the short-term regulation of blood pressure which bring in the sympathetic nervous system) An exposure to intermittent chronic hypoxia (caused by SAS) bring an increased of muscle sympathetic nerve activity (MSNA) contributing to elevated blood pressure Continuous Positive Airway Pressure (CPAP) can partly reduce this risk by decreasing elevation of blood pressure caused by the SAS. It has recently been demonstrated that all CPAP devices are not equivalent. Indeed, the auto-adjusted CPAP treatment induces a reduction in blood pressure lower than the reference treatment fixed CPAP.
To this extent it is interesting to conduct a new randomized trial comparing these two treatments with vascular sympathetic tone. This will be assessed by peroneal microneurography recording.
Objective: Compare Muscle Sympathetic Neural Activity (MSNA) by microneurography after one month of fixed versus auto-adjusted CPAP treatment in OSA patients naive from pressure therapy Methods: Prospective study, single-site, randomized, double-blind, parallel, one month controlled trial. After the diagnosis of sleep apnea, patients will be randomized for one month treatment with fixed ou auto-adjusting CPAP. Measurements of MSNA, heart rate variability and catecholamines will be held before and after treatment.
An interim analysis will be performed after the inclusion of 24 patients based on group sequential design.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patient with OSA (AHI ≥20 / h)
- •patient with daytime sleepiness
- •naive of any pressure treatment of OSA
- •patient able to provide written informed consent
- •not a vulnerable person or legally protected adult.
排除标准
- •pregnancy
- •Person deprived of liberty or subject to a legal protection measure.
- •Patient with serious heart failure (According to investigator judgment)
- •patient with central sleep apnea index above 20% of AHI
- •Patient with a significant intercurrent pathology that can influence the results. (According to investigator judgment).
结局指标
主要结局
Sympathetic tone (MSNA)
时间窗: Change from baseline after one month of intervention
Change from Baseline Sympathetic tone at 1 months
次要结局
- 24 hours Systolic Blood pressure (AMBP)(Change from baseline after one month of intervention)
- Mean Blood pressure (office)(Change from baseline after one month of intervention)
- Catecholamines (epinephrine)(Change from baseline after one month of intervention)
- Diastolic Blood pressure (office) change after 1 month(Change from baseline after one month of intervention)
- 24 hours Diastolic blood pressure change (AMBP)(Change from baseline after one month of intervention)
- Systolic Blood pressure (office)(Change from baseline after one month of intervention)
- Norepinephrine)(Change from baseline after one month of intervention)
- High-frequency component of Heart rate variability(Change from baseline after one month of intervention)
- Dopamine (Catecholamine)(Change from baseline after one month of intervention)
- 24 hours Mean Blood pressure (AMBP)(Change from baseline after one month of intervention)
- Low frequency component of Heart rate variability(Change from baseline after one month of intervention)