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临床试验/NCT06738589
NCT06738589尚未招募不适用

The Inflate Study; Defining the Soft Palate in the Upper Airway Flow Pathway

Fisher and Paykel Healthcare1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年3月25日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
50
试验地点
1
主要终点
Volumetric change of soft palate airway size in delta millimeters cubed,

研究概览

简要总结

The goal of this clinical trial is to understand the impact of the size and shape of the soft palate on gas airflow in the upper airway in healthy volunteers. Utilizing Magnetic Resonance Imaging (MRI), this study aims to investigate:

  • How does soft palate anatomy change in different body positions?
  • What is the impact of positive pressure therapy, in the form of non-invasive ventilation (NIV) on soft palate anatomy? Researchers will compare MRI data without positive pressure to with positive pressure imaging to see if the addition of positive pressure impacts the size and shape of the soft palate.

Researchers will also utilize measures of upper airway resistance to assess the impact of soft palate anatomy of airflow dynamics.

Participants will be asked to:

  • Lie inside an MRI scanner for up to 90 minutes (including breaks), in different body positions
  • Undergo NIV therapy for 5-10 minutes while breathing normally inside an MRI scanner
  • Have their upper airway resistance measured, in different body positions

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Sequential
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

  • Healthy adults aged 18+
  • Willing and able to consent to the study

排除标准

  • Contraindications for MRI (such as metal implants)
  • Contraindications for NIV (such as pneumothorax)
  • No history of lung or upper airway disease
  • Claustrophobia
  • Symptoms of a cold, flu, or significant congestion, within the last 3 days
  • Self-reported confirmed or suspected pregnancy
  • Palatal abnormalities or previous upper airway surgery (such as cleft palate and/or UPPP)
  • Prior major head or neck surgery with or without irradiation (such as radiotherapy of cutaneous cancers, robotic surgery for an oropharyngeal cancer)

结局指标

主要结局

Volumetric change of soft palate airway size in delta millimeters cubed,

时间窗: Single 2 hour visit

millimeters cubed

次要结局

  • Impact of positive pressure ventilation on airway volume in millimeters cubed,(Single 2 hour visit)
  • Upper airway resistance measurements(Single 2 hour visit)

研究者

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

研究点 (1)

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