跳至主要内容
临床试验/NCT01757444
NCT01757444已完成不适用

Clinical Benefits and Tolerance to a New Ventilatory Mode in Patients With Obesity Hypoventilation Syndrome (OHS).

Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche11 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2013年6月1日最近更新:
适应症
干预措施

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

Experimental

BiPAP with AVAPS AE mode

干预措施: BiPAP - A40 (Device)

BiPAP- ST

Active Comparator

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

发起方
Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche
申办方类型
Other
责任方
Principal Investigator
主要研究者

DELRIEU Jacqueline

Coordinator

Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche

研究点 (11)

Loading locations...

相似试验