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临床试验/ACTRN12613000712707
ACTRN12613000712707已完成未知

An evaluation of the comfort of modified CPAP devices in patients with obstructive sleep apnoea

Fisher & Paykel Healthcare0 个研究点目标入组 161 人开始时间: 2013年6月28日最近更新:

试验速览

阶段
未知
状态
已完成
入组人数
161

研究概览

简要总结

The primary outcome of this study was to evaluate patient preference of different prototype Continuous Positive Airway Pressure (CPAP) and masks. 161 of 300 patients were trialed as we were unable to reach the anticipated number of 300 patients. However, this did not adversely affect the outcome of this study and was deemed sufficient. There were no withdrawals of patients or adverse events during the course of the study. The ethics in relation to this study has closed with reference to the following ethics number 13/NTB/63. The results of this study were primarily for internal feedback for future product development and not intended for market release.

研究设计

研究类型
Interventional
分配方式
Randomised controlled trial
主要目的
Treatment
盲法
Blinded (masking used)

入排标准

年龄范围
18 Years 至 o limit(—)
性别
All

入选标准

  • Aged 18 years or older
  • Able to give informed consent
  • (this study will include healthy volunteers, patients that are awaiting a sleep study with a suspicion of OSA, and patients diagnosed with OSA)

排除标准

  • Contraindicated for CPAP/AutoCPAP therapy
  • Must not require supplemental oxygen
  • Must not have critical medical device (i.e. cardiac pacemaker)

研究者

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