A Magnetic Resonance Imaging Study of Nasal Strips in Subjects With Nasal Congestion
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Anatomical Measure: Volume (Single Volume Reading)
研究概览
简要总结
The aim of the study is to evaluate the effect of the nasal strip (relative to the placebo strip) on the nasal passages using anatomical MRI scans and to demonstrate the effect of the strip on breathing correlated cortical activity, using interoceptive fMRI task and analysis techniques derived from physiological data collected during scanning.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants with a self-rating of at least 3 to 8 for nasal congestion on the numerical rating scale
- •Participants with a nasal congestion frequency score of 1, 2, 3 or 4.
排除标准
- •Evidence of obstructive nasal polyps, nasal tract structural malformations, visible open sores, sunburn, irritation, eczema or chronic skin condition on the face or nose
- •Use of any medications like nasal decongestant, alpha adrenergic drugs, glucocorticoids and any current treatment which in the opinion of the investigator will affect nasal congestion
- •Known or suspected intolerance or hypersensitivity to the study materials.
结局指标
主要结局
Anatomical Measure: Volume (Single Volume Reading)
时间窗: Upto 2.5 hours
Determination of single volume reading derived from examination of the nasal passages and sinuses, during the MRI.
Anatomical Measures : Cross Sectional Area
时间窗: Upto 2.5 hours
Determination of cross sectional area derived from examination of the nasal passages and sinuses using T1 weighted MRI scans.
Anatomical Measures: Volume (Multiple Volume Reading)
时间窗: Upto 2.5 hours
Determination of averaged volume reading during the MRI (Average of 8 sub-regions)
Functional Measure: Blood Oxygen Level Dependent- Interoceptive Attention Task (Psychophysiological Interactive Analysis)
时间窗: Upto 2.5 hours
Regional measures of functional brain activity were to be derived from a breathing-related interoceptive task.
Functional Brain Activity: Blood Oxygen Level Dependent- Interoceptive Attention Task
时间窗: Upto 2.5 hours
Regional measures of functional brain activity to be derived from a breathing-related interoceptive task. This outcome measure was pre-specified to analyze effect on nasal strips on the functional brain activity without the use of nasal decongestant.
Cerebral Blood Flow (CBF)
时间窗: Upto 2.5 hours
CBF was derived from Arterial-Spin Labelling (ASL) scans. ASL data were analysed using custom Matlab code, which fits a CBF model to the raw perfusion data, in order to derive quantitative estimates of CBF in units of ml/100g/minute. The computed CBF maps were co-registered to the subject's whole-brain T1-weighted anatomical scan (from the first scan session) in order to spatially divide the data into anatomical Regions of Interest (ROIs). The anatomical ROIs were themselves defined by nonlinear warping of a standard cytoarchitectonic atlas into the space of the subject's T1 anatomical scan, using the FMRIB Software Library tool FNIRT. CBF data were extracted for a subset of these anatomical ROIs.
次要结局
- Breathing-related Cortical Activity (Blood Oxygen Level Dependent- Resting State)(Upto 2.5 hours)
- Verbal Numerical Response (VNR): Change From Baseline to Immediately After Strip Application and 30 Minutes Post Application(Upto 30 minutes)
- VNR: Change From Baseline to 20 Minutes After Decongestant Administration, and Post Application of the Marketed Nasal Strip After Decongestant Administration(Upto 2 hours)