Impact of External Nasal Dilator on the Rhinogram (ARENDS)

This study has been completed.
Sponsor:
Information provided by:
University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier:
NCT01411969
First received: July 26, 2011
Last updated: August 5, 2011
Last verified: June 2011

July 26, 2011
August 5, 2011
June 2010
July 2010   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT01411969 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Impact of External Nasal Dilator on the Rhinogram
Acoustic Rhinometry: Impact of External Nasal Dilator on the Two First Notches of the Rhinogram

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);

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
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Probability Sample

32 nasal cavities of 16 normal adult Caucasian individuals

Nasal Obstruction
Drug: 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.
Other Name: Breath Right®
External nasal dilator, decongestion
Intervention: Drug: External Nasal Dilator Strip; 0.05% oxymetazoline chloride

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
December 2010
July 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01411969
306/03
No
Carlos Eduardo Nazareth Nigro, Ph.D, University of Sao Paulo General Hospital
University of Sao Paulo General Hospital
Not Provided
Study Director: Joao F Mello-Jr, Ph.D University of Sao Paulo General Hospital
University of Sao Paulo General Hospital
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP