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临床试验/NCT01909674
NCT01909674已完成不适用

Differences in Efficacy Between Nasal and Oronasal Masks in the Treatment of Obstructive Sleep Apnea With Continuous Positive Airway Pressure (CPAP): A Randomized Cross-over Study

Weill Medical College of Cornell University1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2011年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
21
试验地点
1
主要终点
Comparison of the Effectiveness of Nasal Versus Oronasal CPAP Masks

研究概览

简要总结

Our group previously conducted a study looking at the performance of three styles of positive airway pressure masks during laboratory treatment studies for obstructive sleep apnea, and we found that patients using a full-mask mask required higher positive airway pressures than patients using nasal or nasal pillows style masks to achieve successful reduction of respiratory events. In the current study we want to randomly assign patients to either nasal or full-face masks and then switch to a different mask (if nasal was originally chosen than the mask will be switched to full-face and vise versa) after 3-weeks of use to see if the number of respiratory events change with the different mask style. We expect the number of respiratory events will increase with the use of full-face masks.

研究设计

研究类型
Interventional
分配方式
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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18 years or older
  • previously diagnosed with OSA
  • returning for PAP titrations at the Center for Sleep Medicine
  • CPAP and titration naive
  • Must have a Apnea/Hypopnea Index (AHI) of ≥ 16/hr.

排除标准

  • Patients with ≥ 50% central apneas

结局指标

主要结局

Comparison of the Effectiveness of Nasal Versus Oronasal CPAP Masks

时间窗: 3 weeks for each mask condition

Total Sleep Time (TST) The amount of actually sleep time in a sleep episode; this time is equal to the total sleep episode less the awake time. TST is the total of all REM and NREM sleep in a sleep episode.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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