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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-05

Study Completion Date

2013-10-30

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.

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Detailed Description

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Conditions

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Nasal Congestion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Test nasal strip

Marketed Nasal Strip to be applied for up to two hours, and during the third scanning session for approximately 20 minutes.

Group Type EXPERIMENTAL

Test strip

Intervention Type DEVICE

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

Nasal spray

Intervention Type OTHER

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

Placebo nasal strip

Placebo nasal strip to be applied for up to two hours in either of the first two scans only.

Group Type PLACEBO_COMPARATOR

Placebo strip

Intervention Type DEVICE

Placebo strip

Nasal spray

Intervention Type OTHER

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

Interventions

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Test strip

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

Intervention Type DEVICE

Placebo strip

Intervention Type DEVICE

Nasal spray

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

Intervention Type OTHER

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes