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临床试验/NCT01171066
NCT01171066已完成不适用

Assessment of the Performance of the Tasman CPAP System in Treating Obstructive Sleep Apnea

ResMed2 个研究点 分布在 1 个国家目标入组 57 人开始时间: 2010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
57
试验地点
2
主要终点
To determine if the efficacy of the treatment is clinically equivalent to or better than the predicate device (S8 Escape)

研究概览

简要总结

Assessment of the performance of the Tasman CPAP system in treating obstructive sleep apnea. The purpose of this study is to (1) evaluate the performance of this system in the efficacy of the treatment in comparison to S8 Escape, and (2) to evaluate the performance of the Tasman device via subjective assessment of comfort and ease of breathing compared to the participant's current CPAP device.

详细描述

Obstructive Sleep Apnoea (OSA) is a condition characterised by 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. The mask is attached to the participant's nose via head straps. The type of mask used is dependent upon participant choice and comfort and the mask that provides the best fit.

Some participants stop using CPAP therapy finding it difficult to tolerate due to leak issues or discomfort from their nasal mask. Another frequent concern is mask dislodgment while sleeping causing leaks and consequently waking the patient up.

The purpose of this study is to evaluate the performance of the Tasman CPAP system via objective and subjective assessment of comfort and ease of breathing compared to the participant's current CPAP device.

Aim

  • To determine if the efficacy of the treatment is clinically equivalent to or better than the predicate device (S8 Escape)
  • To evaluate the performance of the Tasman CPAP system in terms of comfort of breathing and general ease of use

研究设计

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

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

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

To determine if the efficacy of the treatment is clinically equivalent to or better than the predicate device (S8 Escape)

时间窗: 1 week

次要结局

  • To assess the usability of the Tasman CPAP system(1 week)

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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