Pathophysiological Study of Central Sleep Apnea in Adults With Preserved LVEF
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Upper airway collapsibility is assessed by Pcrit value in central leep apnea and snoring
研究概览
简要总结
Sleep apnea is classically divided into obstructive and central apnea, according to the persistence or otherwise of respiratory movements and the existence or not of pharyngeal collapse during apnea. However, there is evidence to suggest that some mechanisms are common to both types of apnea. Although the pathophysiology of obstructive apnea has been the subject of much work and now seems fairly well known, there is much less data on central apnea. These apneas can occur in different comorbid contexts. They are more frequently present in patients with heart failure, regardless of the etiology, and are associated with an adverse prognosis. The investigators hypothesize that the physiopathology of adult central apnea syndrome involves, in addition to ventilatory control abnormalities, upper airway abnormalities (VAS). The objective is to study the pathophysiology of central SAS, by first comparing the collapse of VAS of central apneic patients to those of patients with simple snoring or obstructive sleep apnea. In a second step, the investigators will analyze the cardiorespiratory coupling and will establish a map of the respiratory neural network in patients with central apnea. The investigators will focus their study on patients with central SAS (with preserved systolic heart function) due to the epidemiology of SAS.
详细描述
A non-randomized case-control comparative monocentric physiopathology study with 3 parallel groups (one group of cases and two control groups) matched for age and body mass index (individual 1: 1: 1 match), to evaluate changes in the collapse of VAS in central apnea ("central SAS case"), compared to subjects without central apnea ("obstructive SAS" and "single snoring").
Primary objective : Evaluation of changes in upper airway collapse in patients with central sleep apnea syndrome with preserved LVEF heart failure ("central SAS case"), compared with snoring subjects free from sleep apnea syndrome ("Simple snoring witnesses")
Secondary objectives :
- Study the collapsibility of VAS according to the type of apnea ("central SAS case" versus "obstructive SAS case").
- To study the association between the collapsibility of VAS and the global and central apnea-hypopnoea index (IAH).
- Study the association between the type of disorder ("central SAS case" versus "simple snoring controls", "central SAS case" versus "obstructive SAS controls") and cardiorespiratory coupling.
- Study the association between the type of disorder ("central SAS case" versus "simple snoring controls", "central SAS case" versus "obstructive SAS controls") and the CO2 response slope.
- Establish a map of the respiratory neural network in patients with central SAS with preserved ejection fraction.
- Study the association between the volumes in acoustic pharyngometry and the values of the Pcrit
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male patient
- •Age ≥18 years and ≤85 years
- •With preserved LVEF heart failure (defined as LVEF ≥ 45% on ultrasound, MRI or isotopic ventriculography)
- •Central SAS Group: Central to severe sleep apnea syndrome, defined by an apnea-hypopnoea index (IAH) greater than 15 per hour, of which at least 30% are central events;
- •Obstructive SAS group: Moderate to severe obstructive sleep apnea syndrome, defined by an apnea-hypopnoea index (IAH) greater than 15 per hour, with a central event proportion of less than 30%
- •Group "snoring": absence of sleep apnea syndrome or mild sleep apnea syndrome (IAH <15 / h) in polysomnography, and presence of snoring on at least 30% of the night of recording.
- •Free, informed and written consent
- •Patient affiliated to a social security scheme (beneficiary or beneficiary)
排除标准
- •Impossibility of giving the subject informed information
- •Participation in a research protocol involving the human person in the previous months if an exclusion directive is given in this protocol
- •Use of respiratory or sedative depressant drugs, systemic corticosteroid therapy
- •Impaired systolic function (defined by LVEF <45% in ultrasound, MRI or isotopic ventriculography)
- •Unstable cardiovascular disease (cardiovascular event of less than one month)
- •Recent surgery of the ENT sphere (less than 6 months)
- •Central neurological pathology known
- •Known, severe respiratory pathology (severity left to the investigator's discretion)
- •Renal insufficiency (creatinine clearance <60 mL / min) or severe hepatic impairment
- •Primary or secondary hemostasis disorder
- •Patient on anticoagulant (antivitamin K, direct oral anticoagulant, heparin and related). Antiplatelet agents are allowed.
- •Psychiatric pathology according to DSM-V criteria, unbalanced
- •Pulsed saturation with oxyhemoglobin <88% at rest, on awakening
- •Allergy to lidocaine
- •Patient under tutorship or curatorship
- •Failure to perform a prior medical examination
- •Tympanic perforation
研究组 & 干预措施
Central SAS cases
Patients with central apnea
干预措施: Critical airway closure pressure (Pcrit) measurment (Other)
Obstructive SAS controls
Patients with moderate to severe obstructive apnea (apnea-hypopnoea index ≥ 15 / h)
干预措施: Acoustic pharyngometry (Other)
Central SAS cases
Patients with central apnea
干预措施: Acoustic pharyngometry (Other)
Central SAS cases
Patients with central apnea
干预措施: High density surface electroencephalogram neural mapping (Other)
Obstructive SAS controls
Patients with moderate to severe obstructive apnea (apnea-hypopnoea index ≥ 15 / h)
干预措施: Critical airway closure pressure (Pcrit) measurment (Other)
Snorers controls
Snorers controls : Patients with snoring, with or without mild obstructive apneas (index of apnea-hypopneas <15 / h)
干预措施: Critical airway closure pressure (Pcrit) measurment (Other)
Snorers controls
Snorers controls : Patients with snoring, with or without mild obstructive apneas (index of apnea-hypopneas <15 / h)
干预措施: Acoustic pharyngometry (Other)
结局指标
主要结局
Upper airway collapsibility is assessed by Pcrit value in central leep apnea and snoring
时间窗: 1 day
Pressure values of VAS (Pcrit) in patients in the "Central SAS" group and in the "Obstructive SAS" group
次要结局
- Volume and collapsibility characteristics in acoustic pharyngometry in the different groups(1 day)
- Upper airway collapsibility is assessed by Pcrit value in central and obstructive sleep apnea(1 day)
- The association between Pcrit (cm H20) and Apnea-Hypopnoea Index (events/h)(1 day)
- Chemosensitivity in central sleep apnea is assessed by CO2 response test(1 day)
- Cardiorespiratory coupling in central sleep apnea is assessed by RR measurment (mm on EKG)(1 day)
- Neural network modifications in sleep apnea are assessed by frequency couplage indice(1 day)