Clinical Benefits and Tolerance to a New Ventilatory Mode in Patients With Obesity Hypoventilation Syndrome (OHS).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 11
- 主要终点
- CHANGE IN SLEEP QUALITY
研究概览
简要总结
In 2012, it has announced the availability of the new ventilator (BiPAP- A40), which could offer potential advantages over fixed level pressure support, in particular, in patients with obesity hypoventilation syndrome (OHS). One of the key benefits of the BiPAP A40 is an innovative ventilation mode called AVAPS-AE, which automatically maintains airway patency while delivering the correct level of ventilation each user requires, whatever their body position or sleep stage. AVAPS-AE mode is also aimed to help the clinicians during the initial titration of therapy, while providing long term comfort and assuring therapy compliance. However, studies on the physiologic and clinical effects have not yet been performed. The aim of our singled-blind randomised multicentre controlled trial is to prospectively investigate the effects of BiPAP with the spontaneous/timed (S/T) or the AVAPS-AE ventilation mode over 8 weeks on sleep quality, ventilation pattern, gas exchange, symptoms, body composition, level of physical activity and health-related quality of life in OHS patients.
详细描述
Efficacy on sleep quality, symptoms, physical activity and quality of life
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 85 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Man or woman, stable patient with obesity hypoventilation syndrome, naives of non invasive ventilation.
- •PaCO2 ≥ 45 mmHg.
- •PaO2 < 70 mmHg
- •BMI ≥ 30Kg. m2
排除标准
- •Chronic obstructive pulmonary disease
- •Neuromuscular disease
- •Scoliosis
- •Cardiac insufficiency
- •Significant psychiatric disease
- •Sleep apnea syndrome with central apnea index > 10%
- •Treatment with benzodiazepines at the inclusion
研究组 & 干预措施
BiPAP - A40
BiPAP with AVAPS AE mode
干预措施: BiPAP - A40 (Device)
BiPAP- ST
Patients receiving BiPAP- ST at home
干预措施: BiPAP - ST (Device)
结局指标
主要结局
CHANGE IN SLEEP QUALITY
时间窗: Day 1 and Day 61
Sleep stage, micro arousals, apnea/hypopnea index...
次要结局
- CHANGE IN GAZ EXCHANGE(Day 1 and Day 61)
研究者
DELRIEU Jacqueline
Coordinator
Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche
