Impact of External Nasal Dilator on the Rhinogram (ARENDS)

August 5, 2011 updated by: University of Sao Paulo General Hospital

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);

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

16

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • Sao Paulo, SP, Brazil, 3471
        • University of Sao Paulo General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

32 nasal cavities of 16 normal adult Caucasian individuals

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
External nasal dilator, decongestion
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 Names:
  • Breath Right®

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo General Hospital

Investigators

  • Study Director: Joao F Mello-Jr, Ph.D, University of Sao Paulo General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

July 26, 2011

First Submitted That Met QC Criteria

August 5, 2011

First Posted (Estimate)

August 8, 2011

Study Record Updates

Last Update Posted (Estimate)

August 8, 2011

Last Update Submitted That Met QC Criteria

August 5, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 306/03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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