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临床试验/NCT00850876
NCT00850876已完成不适用

Randomized Cross-over Trials of the Effect of Heated Humidified CPAP Versus Non-humidified CPAP on Nasal Physiology

University of Athens1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2008年9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
入组人数
20
试验地点
1

研究概览

简要总结

Nasal continuous positive airway pressure can cause nasal side effects which can compromise compliance to therapy. Humidifiers can attenuate this effect. However, the mechanism by which humidified CPAP alleviates nasal symptoms has never been assessed objectively in OSA patients. Therefore, the purpose of this study is to examine the effect of humidified CPAP on nasal airway physiology with combined measurements of nasal resistance and level of inflammatory markers. The investigators' hypothesis is that the addition of heated humidification in CPAP decreases nasal airway resistance and nasal mucosal inflammation markers and thus, ameliorates nasal symptoms of OSAS patients.

详细描述

Introduction-Rationale:

Nasal continuous positive airway pressure (CPAP) is considered to be the "gold standard" of obstructive sleep apnoea (OSA) treatment [1]. The most common side effects are nasal congestion, stuffiness or dryness and rhinorrhea which have been reported in up to 68% of patients responding to a questionnaire about nasal CPAP. In many of them, CPAP compliance is accordingly compromised.

The mechanisms by which CPAP provokes nasal symptoms have been thoroughly studied only in healthy volunteers and a rodent model. Indeed, Richards et al demonstrated that mouth leaks causing high unidirectional nasal airflow increased nasal airway resistance and this response could be largely prevented by heated humidification of the inspired air. Similarly, Togias et al showed an elevated release of inflammatory mediators (histamine, prostaglandin D2, kinins) in nasal wash fluids when compressed cold and dry air was delivered through the nose. This effect was also prevented when warm and moist air was delivered. More recently, Almendros et al provided evidence that CPAP use in rats triggered early nasal inflammation.

Of the variety of methods used to treat nasal symptoms during CPAP treatment, the most common is humidification of the inspired air. However, the mechanism Oby which humidified CPAP attenuates nasal symptoms has never been assessed objectively in OSA patients. Therefore, the purpose of this study is to examine the effect of humidified CPAP on nasal airway physiology with combined measurements of nasal resistance and level of inflammatory markers. Our hypothesis is that the addition of heated humidification in CPAP decreases nasal airway resistance and nasal mucosal inflammation markers and thus, ameliorates nasal symptoms of OSAS patients.

Study design:

研究设计

研究类型
Observational
观察模型
Case Crossover
时间视角
Cross Sectional

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

  • Obstructive sleep apnea syndrome defined as apnea/hypopnoea index greater than 20,
  • Initiation of continuous positive airway pressure, and
  • Symptomatic nasal obstruction.

排除标准

  • No medication known to influence nasal resistance (antihistamines, vasoconstrictors, vasodilators, topical or systemic steroids, and recreation drugs),
  • No smoking,
  • No upper or lower respiratory tract disease (e.g. upper respiratory tract infection, rhinitis, sinusitis, chronic obstructive pulmonary disease), including a history of nasal allergy.

研究者

发起方
University of Athens
申办方类型
Other

研究点 (1)

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