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Completed

NCT Number: NCT02275364

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

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.

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Key information

Conditions

Nasal Congestion Airway Obstruction Nasal Obstruction Nose Diseases Otorhinolaryngologic Diseases Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Imanova Centre for Imaging Sciences

London, W12 0NN, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Test strip

Device

Class I device for the application to the nose to facilitate better air flow through the nose

Placebo strip

Device

Placebo strip

Nasal Spray

Other

Nasal decongestant to be used on a single occasion (one spray per nostril), 20 minutes prior to commencing the third MRI scanning sessions.

Primary outcomes

  1. Anatomical Measures : Cross Sectional Area

    Time frame: Upto 2.5 hours

    Determination of cross sectional area derived from examination of the nasal passages and sinuses using T1 weighted MRI scans.

  2. Functional Brain Activity: Blood Oxygen Level Dependent- Interoceptive Attention Task

    Time frame: 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.

  3. Anatomical Measure: Volume (Single Volume Reading)

    Time frame: Upto 2.5 hours

    Determination of single volume reading derived from examination of the nasal passages and sinuses, during the MRI.

  4. Cerebral Blood Flow (CBF)

    Time frame: 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.

  5. Anatomical Measures: Volume (Multiple Volume Reading)

    Time frame: Upto 2.5 hours

    Determination of averaged volume reading during the MRI (Average of 8 sub-regions)

  6. Functional Measure: Blood Oxygen Level Dependent- Interoceptive Attention Task (Psychophysiological Interactive Analysis)

    Time frame: Upto 2.5 hours

    Regional measures of functional brain activity were to be derived from a breathing-related interoceptive task.

Secondary outcomes

  1. Breathing-related Cortical Activity (Blood Oxygen Level Dependent- Resting State)

    Time frame: Upto 2.5 hours

    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.

  2. Verbal Numerical Response (VNR): Change From Baseline to Immediately After Strip Application and 30 Minutes Post Application

    Time frame: Upto 30 minutes

    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.

  3. VNR: Change From Baseline to 20 Minutes After Decongestant Administration, and Post Application of the Marketed Nasal Strip After Decongestant Administration

    Time frame: Upto 2 hours

    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.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Oct 27, 2014
Registry last updated
Aug 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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