Observational and Transversal Study of Patients Treated in "Real Life"Conditions With Adaptive Servo-Ventilation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 214
- 试验地点
- 10
- 主要终点
- Residual Apnea Hypopnea Index (AHI) evaluated by the ASV device and associated pressure settings
研究概览
简要总结
Adaptive Servo-Ventilation (ASV) treatment is routinely prescribed in France. In order to be reimbursed according to the French Social Security rules, the patient treated with an ASV needs to be examined each year. In this observational transversal single-visit study, the investigators aim to describe the clinical characteristics of patients treated with ASV and the associated device settings.
详细描述
The purpose of this study is to evaluate in "real life conditions" the use of Adaptative Servo-Ventilation (ASV) treatment. ASV treatment is routinely prescribed in France in patients with various sleep disorders breathing (Chronic Heart Failure (CHF) and Central Sleep Apnea Syndrome (CSAS), CHF and central and obstructive sleep apnea (COSA), Obstructive Sleep Apnea Syndrome (OSAS) and complex sleep apnea syndrome (compSAS), idiopathic or drug induced periodic breathing.
In order to be reimbursed according to the French Social Security rules, the patient treated with an ASV needs to be examined each year. In this observational transversal single-visit study, the aim is to describe the clinical characteristics of patients treated with ASV and the associated device settings. The aim is to evaluate the safety and efficacy issues in real life conditions of the ASV prescription.Depending of the data, data are obtained after analysis of the six latest months data of the ASV device, after questioning the patient, after analysis of the polygraphy/oximetry (if prescribed by the doctor for the renewal consultation of the ASV care and reimbursement by the French Social Security). All the data are obtained during the annual consultation required by the French Social Security.
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
- •Written informed consent
- •Age more than 18 years (inclusive)
- •Patient treated with ASV for at least one year,and eligible for care and for the reimbursement by the French Social Security rules.
- •Patient presenting at the annual control consultation for the continuation of the ASV treatment according to the French Social Security rules.
排除标准
- •Pregnancy, intention of being pregnant, breastfeeding.
- •Inability to understand the nature and aims of the study or to communicate with the investigator
- •Simultaneous participation in another trial with an exclusion clause to participate to an other trial.
- •No affiliation to the French social security
- •Loss of personal capacity resulting in state protection
- •Deprivation of liberty by judicial or administrative decision
结局指标
主要结局
Residual Apnea Hypopnea Index (AHI) evaluated by the ASV device and associated pressure settings
时间窗: The measures are performed during the annual consultation required by the French Social Security for the renewal of the reimbursement of the ASV care. The measures are obtained after analysis of the six latest months data of the device.
Relationship between the residual AHI and the associated pressure settings, in function of the phenotype of the patients (presence or absence of cardiopathy, presence or absence of altered left ventricular ejection fraction (≤45% or \> 45%)
次要结局
- Settings of the device (Inspiratory and Expiratory pressures, duration of pressurization, backup frequency)(The day of inclusion during the consultation or in a maximum delay of 15 days after (if the patient forgot to bring his device))
- Sleep Disorder Breathing involved in the initial prescription of ASV(The day of inclusion)
- Number of hospitalization during the last year and etiology of the hospitalization(The day of inclusion)
- Treatment of the cardiomyopathy (medication consumption and use of cardiac implant will be reported)(The day of inclusion)
- ASV compliance (number of hour per day, number of day with ≥3 hours in the past 6 months)(The day of inclusion during the consultation or in a maximum delay of 15 days after (if the patient forgot to bring his device))
- Type of device used nad history of device used (CPAP used before ASV ?)(The day of inclusion during the consultation or in a maximum delay of 15 days after (if the patient forgot to bring his device))
- Used or not of an auto-EPAP(The day of inclusion during the consultation or in a maximum delay of 15 days after (if the patient forgot to bring his device))
- Changes in AHI as compared to baseline(The day of inclusion during the consultation or in a maximum delay of 15 days after (if the patient forgot to bring his device))
- Type of mask used and historical use of mask(The day of inclusion during the consultation or in a maximum delay of 15 days after (if the patient forgot to bring his device))
- Number of patients not showing up for the annual consultation(One year after the start of the study)
- Changes in Daytime Sleepiness by measuring Epworth scale as compared to baseline if available(The day of inclusion)
- Changes in Asthenia by measuring Pichot scale as compared to baseline if available(The day of inclusion)
- Presence of a cardiomyopathy(The day of inclusion)