Registry on the Treatment of Central and Complex Sleep-Disordered Breathing With Adaptive Servo-Ventilation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- ResMed
- 入组人数
- 847
- 试验地点
- 29
- 主要终点
- Quality of Life, assessed with the Functional Outcomes of Sleep Questionnaire (FOSQ) by comparing the score at baseline with the 12 months follow-up.
研究概览
简要总结
Phase 1: The European ASV Registry (short name) will investigate the use of Adaptive Servo-Ventilation in non-heart failure conditions. The purpose is to examine the effects of ASV on quality of life, daytime symptoms and sleep, to describe usage patterns of ASV with regards to patient characteristics and to document adverse events related to therapy for a therapy safety analysis. A pilot phase will enrol at least 200 patients to test the feasibility of the registry. After the pilot phase will be completed and an intermediate data analysis had been performed, the registry will be expanded over several countries across Europe with the goal of enrolling up to 800 patients over a period of 5 years. Phase 2: The READ-ASV Registry (short name) will investigate the use of Adaptive Servo-Ventilation in non-heart failure conditions. The purpose is to examine the effects of ASV on quality of life, daytime symptoms and sleep, to describe usage patterns of ASV with regards to patient characteristics and to document adverse events related to therapy for a therapy safety analysis.
详细描述
Phase 1: The collection of data will be performed during the course of clinical routine. In regular clinical practice, a first control visit (i.e. Follow-up number one) should occur during the first 6 months. Further follow-up visits are only indicated when the patient is reporting problems during the course of therapy. We recommend FU visit at least once year (after the first routine FU visit). Each patient will be included for 6 months, the total duration of phase 1 of the registry. Phase 2: The pilot phase 1 enrolled over 200 patients. After completion of the pilot phase the registry expands to 1 additional country in Europe with the goal of enrolling up to 800 patients over a period of 4 years. The collection of data will be performed during the course of clinical routine. In regular clinical practice, a first control visit (i.e. Follow-up number one) should occur after the first 12 months of therapy use. Further follow-up visits are only indicated when the patient is reporting problems during the course of therapy. Each patient will be included for a maximum of 15 months, whereas serious events will be tracked throughout the total duration of phase I and II of the registry.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over ≥18 years of Age
- •Prescription of ResMed AirCurve 10 CS PaceWave or S9 AutoSet CS PaceWave for treatment of ASV
- •Naive to ASV Treatment
- •Able to fully understand information on data protection and provide written informed consent
排除标准
- •Heart Failure (HF) with a Left Ventricular Ejection Fraction (LVEF) <45% and CSA >50% central apneas of all apneas
- •Phase 2: Inclusion Criteria:
- •≥ 18 years old.
- •Indication for treatment with ASV according to applicable medical guidelines.
- •Use of eligible ResMed devices for treatment with ASV according to the Instructions For Use of the corresponding device.
- •Naive to ASV treatment (max. 7 days between start of ASV therapy and enrolment).
- •Able to fully understand information on data protection and provide written informed consent for use of their medical data.
- •Phase 2: Exclusion Criteria:
- •Chronic, symptomatic heart failure (NYHA 2-4) with reduced left ventricular ejection fraction (LVEF ≤ 45%) and moderate to severe predominant central sleep apnea.
结局指标
主要结局
Quality of Life, assessed with the Functional Outcomes of Sleep Questionnaire (FOSQ) by comparing the score at baseline with the 12 months follow-up.
时间窗: 12 months
The Functional Outcomes of Sleep Questionnaire had been developed to comprehensively capture the impact of sleeping disorders in relevant daily activities as for instance general activity, vigilance, intimacy, fitness and social life.
Phase 2: Quality of Life, assessed with the Functional Outcomes of Sleep Questionnaire (FOSQ) by comparing the score at baseline with the follow-up after 12 months.
时间窗: Baseline to 12 months
The Functional Outcomes of Sleep Questionnaire had been developed to comprehensively capture the impact of sleeping disorders in relevant daily activities as for instance general activity, vigilance, intimacy, fitness and social life. The FOSQ consists of 30 questions, answer options ranging from 4 (no problems) to 1(severe problems) or 0(not applicable) adding up to a total score between 5(worst functional status)-20(best functional status).
次要结局
- Quality of Sleep assessed with the Pittsburgh Sleep Quality Index (PSQI) at baseline compared with the follow-up after 12 months.(12 months)
- Daytime symptoms assessed with the EuroQoL (EQ-5D) by comparing the answers at baseline with answers at the follow-up at 12 months.(12 months)
- Daytime sleepiness assessed with the Epworth Sleepiness Scale (ESS) by comparing the score at baseline with the follow-up after 12 months.(12 months)
- Safety of ASV therapy assessed by documenting the number of adverse Events and the number of hospitalizations at the Overall end of the study.(6 months)
- Phase 2: Therapy compliance assessed by the hours of usage per night.(Baseline to 12 months)
- Phase 2: Daytime symptoms assessed with the EuroQoL (EQ-5D) by comparing the answers at baseline with answers at the follow-up at 12 months.(Baseline to 12 months)
- Phase 2: Rate of hospitalizations for cardiovascular or respiratory cause per year of follow-up.(12 months)
- Central Apnea Index assessed by the number of central apneas per hour.(6 months)
- Phase 2: Daytime sleepiness assessed with the Epworth Sleepiness Scale (ESS) by comparing the score at baseline with the follow-up after 12 months.(Baseline to 12 months)
- Phase 2: Rate of all-cause deaths per year of follow-up.(12 months)
- Therapy compliance assessed by the hours of usage per night.(6 months)
- Apnea-Hypopnea-Index assessed by the number of Apneas and hypopneas per hour.(6 months)