Assessment of the Effect of the Shape of an Inhaler's Mouthpiece on Upper Airway Geometry, Using Functional Respiratory Imaging and Pharyngometry.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Changes in upper airway geometry by using MRI.
研究概览
简要总结
In this study the possible changes in upper airway geometry induced by variations in the characteristics of the mouthpieces of inhalers will be evaluated with functional respiratory imaging (FRI) and Pharyngometry. The study population consists of 12 healthy male subjects.
Different mouthpiece designs will be evaluated for each subject by using magnetic resonance imaging (MRI) scans. The results will help to identify the influence of the height, width, protrusion and resistance of the mouthpiece on upper airway geometry.
Pharyngometry profiles of all subjects, whilst inhaling through different mouthpiece variants, in supine and upright position, will be completed.
A computed tomography (CT) scan and a cone beam computed tomography (CBCT) scan of the upper airway will be taken to respectively compare the time dependence on 3D imaging with MRI and to provide a 3D image in an upright position.
Dental impressions will be optically scanned to obtain a more accurate representation of the oral cavity, mainly in MRI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male subject ≥ 18 years old
- •Written informed consent obtained
- •BMI ≥ 20 kg/m2 and < 25 kg/m2
- •Height ≥ 175 cm and ≤ 185 cm
- •Subject must be able to understand and complete the protocol requirements, instructions and protocol-stated restrictions.
排除标准
- •Subject with claustrophobia
- •Subject with a history of surgery of the upper airway
- •Subject with an enlarged thyroid gland
- •Subject with intra-oral piercings
- •Subject with dental bracket
- •Subject with a pacemaker or another implant that is likely to interfere with the MRI procedure
- •Subject that is unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study
- •Subject who received any investigational new drug within the last 4 weeks prior to visit 1.
结局指标
主要结局
Changes in upper airway geometry by using MRI.
时间窗: Within 20 days after day 1
The primary objective of this study is to evaluate with MRI-FRI the possible changes in upper airway geometry induced by using different mouthpieces.
次要结局
- Changes in upper airway geometry by using pharyngometry in supine versus upright position.(Within 20 days after day 1)