Functional Magnetic Resonance Imaging (fMRI) Study of Nasal Strips in Nasal Congestion

Study Overview
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Brief Summary
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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.

Official Title
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A Magnetic Resonance Imaging Study of Nasal Strips in Subjects With Nasal Congestion

Conditions
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Nasal Congestion

Intervention / Treatment
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* Device: Test strip
* Device: Placebo strip
* Other: Nasal spray


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test nasal strip<br>Marketed Nasal Strip to be applied for up to two hours, and during the third scanning session for approximately 20 minutes. | Device: Test strip<br>* Class I device for the application to the nose to facilitate better air flow through the nose<br>Other: Nasal spray<br>* Nasal decongestant to be used on a single occasion (one spray per nostril), 20 minutes prior to commencing the third MRI scanning sessions.<br>|
| Placebo Comparator: Placebo nasal strip<br>Placebo nasal strip to be applied for up to two hours in either of the first two scans only. | Device: Placebo strip<br>* Placebo strip<br>Other: Nasal spray<br>* Nasal decongestant to be used on a single occasion (one spray per nostril), 20 minutes prior to commencing the third MRI scanning sessions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anatomical Measures : Cross Sectional Area | Determination of cross sectional area derived from examination of the nasal passages and sinuses using T1 weighted MRI scans. | Upto 2.5 hours | 
| Functional Brain Activity: Blood Oxygen Level Dependent- Interoceptive Attention Task | 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. | Upto 2.5 hours | 
| Anatomical Measure: Volume (Single Volume Reading) | Determination of single volume reading derived from examination of the nasal passages and sinuses, during the MRI. | Upto 2.5 hours | 
| Cerebral Blood Flow (CBF) | 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. | Upto 2.5 hours | 
| Anatomical Measures: Volume (Multiple Volume Reading) | Determination of averaged volume reading during the MRI (Average of 8 sub-regions) | Upto 2.5 hours | 
| Functional Measure: Blood Oxygen Level Dependent- Interoceptive Attention Task (Psychophysiological Interactive Analysis) | Regional measures of functional brain activity were to be derived from a breathing-related interoceptive task. | Upto 2.5 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Breathing-related Cortical Activity (Blood Oxygen Level Dependent- Resting State) | Regional measures of breathing-related cortical activity were derived by determining Functional Connectivity and Event-related percentage signal change. Functional connectivity analyzes of fMRI data where spontaneous (i.e. while the participant is at rest) signal changes in one brain region are regressed against other regions, to identify regions sharing similar functional properties. Event-related functional magnetic resonance imaging (efMRI) detects changes in the BOLD hemodynamic response to neural activity associated with certain event. In this case, the events were pre-defined by collecting additional data during the scan; participant respiration was determined using a simple pressure-sensitive respiration belt. Events time-locked to peak inspiration and expiration were defined separately, and regressed against brain activity, showing brain regions that were more or less active during each event type. | Upto 2.5 hours | 
| Verbal Numerical Response (VNR): Change From Baseline to Immediately After Strip Application and 30 Minutes Post Application | Participants provided their response for VNR on a scale of 0 to 10 (0 = Breathe Freely and 10 = Totally Blocked) how easy it was to breathe through nose at a given time. | Upto 30 minutes | 
| VNR: Change From Baseline to 20 Minutes After Decongestant Administration, and Post Application of the Marketed Nasal Strip After Decongestant Administration | Participants provided their response for VNR on a scale of 0 to 10 (0 = Breathe Freely and 10 = Totally Blocked) how easy it was to breathe through nose at a given time. | Upto 2 hours |