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临床试验/NCT01013207
NCT01013207已完成不适用

Assessment of the Compliance and Usability of the Nexus (S9) CPAP System in Sleep Disordered Breathing

ResMed2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2009年11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
50
试验地点
2
主要终点
Compliance on CPAP

研究概览

简要总结

Obstructive sleep apnoea (OSA) is characterised by a partial or complete collapse of the upper airway during sleep. The treatment of choice for OSA is Continuous Positive Airway Pressure (CPAP). CPAP acts as a positive airway splint, delivering a fixed positive airway pressure to the upper airway via a tube and mask. Humidification is used during CPAP therapy to improve the comfort of the delivered air and to alleviate nasal dryness/congestion.

The latest design of a CPAP device, known as Nexus (S9), encompasses new features including an improved humidification system (heated tube and climate control), reduced noise, improved comfort of breathing, and a new user interface.

This study will assess whether compliance on CPAP therapy is improved on the Nexus (S9) CPAP, and will assess the usability of the Nexus (S9) CPAP

详细描述

Obstructive Sleep Apnoea (OSA) is a condition characterised by the partial or complete collapse of the upper airway during sleep. OSA comprises a continuous spectrum of severity ranging from simple snoring and upper airway resistance through mild to severe symptomatic obstructive hypopnoea and apnoea. The prevalence of sleep disordered breathing in the adult population is 24% males and 9% for females. The prevalence of symptomatic OSA in the adult population has been estimated to be 4% in males and 2% in females. These patients demonstrate behavioural and neuropsychological consequences to varying degrees, including excessive daytime sleepiness, intellectual deterioration and depression. More serious consequences include arterial systemic hypertension, arterial pulmonary hypertension and heart disease.

The treatment of choice for OSA is Continuous Positive Airway Pressure (CPAP). CPAP acts as a positive airway splint, delivering a fixed positive airway pressure to the upper airway via a tube and mask. Humidification is used during CPAP therapy to improve comfort of the delivered air and alleviate nasal dryness/congestion.

Compliance with CPAP is a known issue which is affected by many things, including negative side effects and issues with the equipment. The most common complaints involve nasal dryness/congestion and noise from the machine.

The purpose of this study is to assess whether the improved humidification system, reduced noise, improved comfort of breathing and new user interface on the Nexus (S9) CPAP will improve compliance.

Aims:

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Treatment
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

  • Willingness to provide written informed consent
  • Patients who are using a ResMed mask system
  • Patients who are at least 18 years of age
  • Patients who use a ResMed CPAP device

排除标准

  • Patients currently using Bilevel PAP
  • Patients who are pregnant
  • Patients who the researcher believes are unsuitable for inclusion because either:
  • they do not comprehend English
  • they are unable to provide written informed consent
  • they are physically unable to comply with the protocol

结局指标

主要结局

Compliance on CPAP

时间窗: 12 weeks

Compliance on CPAP was measured as average daily usage

次要结局

  • Usability of the Nexus (S9) CPAP.(4 weeks)

研究者

发起方
ResMed
申办方类型
Industry

研究点 (2)

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