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临床试验/NCT01037439
NCT01037439已完成不适用

Comparison of a Modified Adaptive Servoventilation With Conventional Adaptive Servoventilation Processes in Terms of Efficacy Against Complex Nocturnal Breathing Disorders

ResMed2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2008年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
ResMed
入组人数
20
试验地点
2
主要终点
Apnea/hypopnea index (AHI)

研究概览

简要总结

The objective of this study is to compare the modified adaptive servoventilation control algorithm of the with the standardised algorithms of routinely-used servoventilation processes (AutoSet CS2) in terms of the effect on obstructive and central events. The aim is to normalise breathing during sleep and hence eliminate the sleep-related breathing disorder, resulting in even more effective treatment of nocturnal breathing disorders in patients with cardiovascular diseases and sleep apnoea, to ensure optimum therapy success.

详细描述

Patients with cardiovascular disorders frequently suffer from sleep-related respiratory disorders (SRRD), such as obstructive sleep apnea (OSA) or a specific form of central sleep apnea, Cheyne-Stokes breathing (CSB, periodic breathing). However there is also a significant incidence of complex nocturnal breathing disorders, with both obstructive and central components. Sleep-related breathing disorders of this kind cause decreases in arterial oxygen saturation through brief hypopneas and apneas. Disturbed breathing also causes the patient to wake frequently during the night (arousals), usually during the hyperventilatory phase of CSB. Repeated arousals cause fragmentation of sleep, and therefore a deep sleep deficit. This leads to increased sleepiness during the day and impaired cognitive performance.

Previous studies have shown that Cheyne-Stokes breathing can be treated effectively with adaptive servoventilation. An enhancement to the routinely used algorithm (AutoSet CS2) has been created which allows the algorithm to differentiate between obstructive events and Cheyne-Stokes breathing, and better respond to apneas and hypopneas to eliminate the sleep-related breathing disorder and normalise breathing during sleep.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18+ years of age
  • consent in writing
  • complex nocturnal breathing disorder with Cheyne-Stokes breathing and obstructive sleep apnoea
  • AHI > 15/h

排除标准

  • acute cardiac decompensation
  • acute myocardial infarct within the last 3 months
  • post-resuscitation condition within the last 3 months
  • post-stroke condition with difficulty in swallowing or persisting hemiparesis
  • abuse of medication, alcohol or drugs
  • pregnancy
  • known to be suffering from a tumour

结局指标

主要结局

Apnea/hypopnea index (AHI)

时间窗: 1 night sleep

number of breathing pauses that occur each hour of sleep

次要结局

  • Average SaO2(1 night sleep)
  • Pressure stability in presence of mask leaks(1 night sleep)
  • CPAP pressure(1 night sleep)
  • Minimum SaO2(1 night sleep)

研究者

发起方
ResMed
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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