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临床试验/NCT06682286
NCT06682286招募中不适用

Breathing Route in COPD and OHS Patients on Long-term Home Non-invasive Ventilation: An Experimental Study

Fisher and Paykel Healthcare2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年1月24日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
40
试验地点
2
主要终点
Breathing route while on and off pressure support (awake)

研究概览

简要总结

COPD and OHS are respiratory conditions that disrupt normal breathing. Positive airway pressure, specifically Non-Invasive Ventilation (NIV), has been shown to improve breathing and reduce symptoms in patients with these conditions. Regular use of NIV can lead to better symptom management, improved quality of life, and reduced use of healthcare resources. The type of mask used for breathing support can greatly affect a patient's comfort and willingness to use it. For conditions like Obstructive Sleep Apnea (OSA), which is a physical blockage of the airway caused by the relaxation of the muscles of the throat, nasal masks are often used because they are comfortable and work well. But for breathing support in the hospital, full face masks are typically used because patients are having significant trouble breathing and tend to breathe through their mouth.

However, it's important to note that we don't yet fully understand the best way to provide breathing support for long-term NIV users, like COPD and OHS patients. The understanding of breathing route is currently only established for OSA. However, conditions like COPD affect the lungs and the overall system used for breathing, which is different from the throat blockage seen in OSA. So, the assumptions we make based on conditions like OSA may not apply to these other conditions. More research is needed to understand this better.

详细描述

  • Participants undergo PSG, lying on their backs while their breathing route is recorded for about 30 minutes.
  • The participants are then put on their prescribed airway pressure support with the first randomized mask, and their breathing is recorded again for 30 minutes.
  • The mask is switched to the second mask, and the same procedure is repeated.

Participants are then moved to the sleep laboratory for the night where they are provided with beds.

  • They continue NIV therapy with the last mask used during the awake test.
  • After at least 60 minutes of recording, participants are awakened to switch back to the first mask. They are then allowed to sleep uninterrupted for the rest of the night.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
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

  • Age over 18 years
  • Prescribed nocturnal NIV for COPD or OHS
  • Able to complete an overnight sleep study
  • Comfortable to sleep on a standard double bed
  • Capacity to complete informed consent

排除标准

  • Uncontrolled sleep apnea (Apnea-hypopnea index (AHI) over 15 events/hour off personal NIV device data)
  • Prescribed IPAP above 25 cmH2O
  • Self-reported pregnancy
  • Allergic to adhesive of the sensors
  • Self-reported cold/flu symptoms

结局指标

主要结局

Breathing route while on and off pressure support (awake)

时间窗: 4 hours

Percent of time nose and mouth breathing in COPD and/or OHS patients while on and off pressure support.

Breathing route while on pressure support (asleep)

时间窗: 8 hours

Percent of time nose and mouth breathing in COPD and/or OHS patients while on pressure support during sleep.

Mask type influence on breathing route (asleep and awake)

时间窗: 12 hours

Percent of time nose and mouth breathing in COPD and/or OHS patients depending on the NIV mask type

次要结局

未报告次要终点

研究者

发起方
Fisher and Paykel Healthcare
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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