Impact of External Nasal Dilator on the Rhinogram

NCT ID: NCT01411969

Last Updated: 2011-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

16 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-06-30

Study Completion Date

2010-12-31

Brief Summary

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The aim of this study is to present new data for a better understanding of the anatomic correlation of these two notches.

This study included 32 nasal cavities (16 individuals) with external nasal dilator strip (Breath Right®) and after decongestion (0.05% oxymetazoline chloride applied as an aerosol spray);

Detailed Description

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Acoustic rhinometry is more accurate in the anterior portion of the nasal cavities, from the nostril to the nasal valve (NV), the most important site of nasal obstruction. Literature presents different opinions regarding the anatomical correlation of the two notches at the beginning of the rhinogram curve in normal adult Caucasian individuals.

This prospective study included 32 nasal cavities under the following conditions: 1st - basal condition; 2nd - with external nasal dilator strip (ENDS) (Breath Right®); 3rd - after decongestion (0.05% oxymetazoline chloride applied as an aerosol spray); 4th - after decongestion with ENDS.

Conditions

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Nasal Obstruction

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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External nasal dilator, decongestion

External Nasal Dilator Strip; 0.05% oxymetazoline chloride

Intervention Type DRUG

External Nasal Dilator Strip placed above the upper lateral cartilage; 20 minutes after decongestion with 0.05% oxymetazoline chloride applied as an aerosol spray (two times); after decongestion with ENDS.

Interventions

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External Nasal Dilator Strip; 0.05% oxymetazoline chloride

External Nasal Dilator Strip placed above the upper lateral cartilage; 20 minutes after decongestion with 0.05% oxymetazoline chloride applied as an aerosol spray (two times); after decongestion with ENDS.

Intervention Type DRUG

Other Intervention Names

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Breath Right®

Eligibility Criteria

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Inclusion Criteria

* Adult, Caucasian

Exclusion Criteria

* Allergies, sinusitis, nasal polyps, external nasal deformities congenital or acquired, obstructive nasal deviation and regular use of any drug.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Sao Paulo General Hospital

OTHER

Sponsor Role lead

Responsible Party

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University of Sao Paulo General Hospital

Principal Investigators

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Joao F Mello-Jr, Ph.D

Role: STUDY_DIRECTOR

University of Sao Paulo General Hospital

Locations

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University of Sao Paulo General Hospital

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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Seren E. The effect of an adhesive external nasal dilator strip on the inspiratory nasal airflow. Am J Rhinol Allergy. 2010 Jan-Feb;24(1):e29-31. doi: 10.2500/ajra.2010.24.3426.

Reference Type RESULT
PMID: 20109318 (View on PubMed)

Nigro CE, Mion O, Mello JF Jr, Voegels RL, Roithmann R. Acoustic rhinometry: impact of external nasal dilator on the two first notches of the rhinogram. Am J Rhinol Allergy. 2011 Nov-Dec;25(6):e247-50. doi: 10.2500/ajra.2011.25.3708.

Reference Type DERIVED
PMID: 22185733 (View on PubMed)

Other Identifiers

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306/03

Identifier Type: -

Identifier Source: org_study_id

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