A Prospective Multicenter Registry of Patients With Sleep Disordered Breathing Treated With DreamStation BiPAP autoSV.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 129
- 试验地点
- 9
- 主要终点
- Short term Device usage and therapy adherence
研究概览
简要总结
This multi-center observational study will prospectively collect data from patients who have an indication for servo ventilation therapy. This registry is intended to characterize the patient populations that may benefit from DreamStation BiPAP autoSV therapy (PR DS-autoSV, Philips Respironics, Monroeville, PA) in real life settings. In addition, this registry will assess adherence to the PR DS-autoSV therapy, the therapeutic benefits, collect morbidity and mortality data of servo ventilation in patients with central sleep apnea (CSA) and complex sleep-disordered breathing (SDB).
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
- •Indication and prescription of PR DS-autoSV
- •Polysomnographic (PSG) or Polygraphic (PG) documentation of sleep-disordered breathing requiring servo ventilation
排除标准
- •Patients with HFrEF - heart failure and low ejection fraction (EF ≤ 45%) and predominant CSA (> 50 % of events)
- •Patients not able to receive positive airway pressure support through a mask due to surgical procedure or anatomical condition
- •Chronic conditions with life expectancy < 1 year
- •Significant chronic obstructive pulmonary disease (COPD) with an FEV1/VC < 70% (GOLD III)
- •Respiratory insufficiency requiring long-term oxygen therapy
- •Daytime hypercapnia at rest (pCO2 > 45 mmHg)
- •Cardiac surgery, PCI, myocardial infarction, unstable angina, within 12 weeks prior to enrolment
- •Cardiac resynchronization or pacemaker implantation within the last 6 months
- •Untreated or therapy refractory Restless legs-Syndrome (RLS)
结局指标
主要结局
Short term Device usage and therapy adherence
时间窗: 6 months
Device usage (hours/ night). Patients will be classified into various adherence subgroups based on the average daily device use at each study interval. The percentage of participants in each of the adherence subgroups will be presented.
次要结局
- Long term Device usage and therapy adherence(12 months)
- Change in Daytime sleepiness.(6, 12 and 24 months)
- Change on PSG/PG Parameters from baseline(6 months)
- Change in Subjective sleep quality(6, 12 and 24 months)
- Change in Health-related quality of life(6, 12 and 24 months)
- Mortality(6, 12 and 24 months)
- Causes of death(6, 12 and 24 months)
- Number of healthcare utilization(6, 12 and 24 months)