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临床试验/NCT03472612
NCT03472612已完成不适用

Pathophysiology of Obstructive Sleep Apnoea Recurrence During Continuous Positive Airway Pressure Therapy Withdrawal

Guy's and St Thomas' NHS Foundation Trust2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2018年4月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
25
试验地点
2
主要终点
Change in neural respiratory drive (NRD) during sleep upon CPAP therapy withdrawal

研究概览

简要总结

Continuous positive airway pressure (CPAP) therapy is the most effective Treatment for obstructive sleep apnoea (OSA ). However, adherence to CPAP is often limited. There are established and emerging treatment alternatives to CPAP available, however, they are usually less effective than CPAP. To develop novel treatment methods and to predict who will respond to which treatment, the mechanism underlying obstructive sleep apnoea and different patient types should be described. Especially the contribution of the upper airway function and central respiratory control should be studied for this purpose. In a prospective interventional study, patients with OSA effectively treated with CPAP will undergo physiologic measurements during a two week period off CPAP to define the pathophysiological mechanisms associated with OSA recurrence. This knowledge could facilitate individually tailored treatment and improve therapy adherence and patient outcomes.

详细描述

Obstructive sleep apnoea (OSA) is a highly prevalent sleep-related breathing disorder characterised by a repetitive collapse of the pharynx during sleep, which results in apnoea or hypopnoea associated with oxygen desaturations and arousal from sleep. Continuous positive airway pressure (CPAP) is the gold standard treatment. Treatment success depends on regular CPAP usage. However, low adherence to CPAP is a frequent problem. It has recently been shown that OSA does not re-occur immediately in all OSA patients upon CPAP therapy withdrawal and that there are different patterns of recurrence of OSA as indicated by repeated sleep studies. So far, the mechanisms of OSA recurrence upon CPAP therapy withdrawal are incompletely understood. Upper airway collapsibility and neuromuscular tone, pharyngeal oedema and inflammation, neural respiratory drive, sleep stage and position may play a role.

In a prospective interventional study, patients with OSA effectively treated with CPAP will undergo physiologic measurements during a two week period off CPAP to define the pathophysiological mechanisms associated with OSA recurrence. In particular, we will investigate the effects of CPAP withdrawal on neural respiratory drive and upper airway function. Inpatient sleep studies and assessments will be performed at baseline (day 0) on CPAP and at follow-up upon CPAP withdrawal (day 14). At the end of the trial patients will return to their established CPAP therapy.

We hypothesise that CPAP withdrawal results in different patterns of OSA recurrence defined by neural respiratory drive and upper airway function. The aim of the proposed project is to study the mechanisms of OSA recurrence by using a validated CPAP withdrawal model. Knowledge on recurrence patterns and different phenotypes of OSA could facilitate individually tailored treatment of OSA and improved therapy adherence and patient outcomes.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Change in neural respiratory drive (NRD) during sleep upon CPAP therapy withdrawal

时间窗: 2 weeks

Electromyography of respiratory muscles as measure of neural respiratory drive

次要结局

  • Home and office blood pressure(2 weeks)
  • Pharyngeal critical occlusion pressure during sleep (Pcrit)(2 weeks)
  • Forced expiratory volume in 1 second(2 weeks)
  • Fatigue Severity Sclae (FSS)(2 weeks)
  • Stanford Sleepiness Scale (SSS)(2 weeks)
  • Pharyngeal oedema(2 weeks)
  • Home and office heart rate(2 weeks)
  • Forced oscillation technique (FOT)(2 weeks)
  • Negative expiratory pressure (NEP)(2 weeks)
  • Recurrence pattern of OSA defined by the nightly obstructive respiratory events (apnoea-hypopnoea-index)(2 weeks)
  • Epworth Sleepiness Scale Score (ESS)(2 weeks)
  • Forced vital capacity(2 weeks)
  • Recurrence pattern of OSA defined by the nightly obstructive respiratory events (oxygen desaturation index)(2 weeks)
  • Functional Outcomes of Sleep Questionnaire (FOSQ)(2 weeks)
  • Association between ODI (recurrence pattern of OSA) and neural respiratory drive (NRD)(2 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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