Back to resultsThe Effect of Nasal Hair on Nasal Obstruction
Primary Purpose
Nasal Obstruction
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vibrissae trimming
Application of oxymetazoline
Sponsored by
About this trial
This is an interventional treatment trial for Nasal Obstruction focused on measuring Nasal obstruction, Vibrissae, Nasal hair
Eligibility Criteria
Inclusion Criteria:
- Presence of nasal vibrissae
- Able to tolerate rhinomanometry
Exclusion Criteria:
- Anatomical or other obvious cause of obstruction
- Claustrophobia with rhinomanometry mask
Sites / Locations
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Vibrissae trimming
Arm Description
Patients will serve as their own control, with assessment of primary outcomes pre- and post-trimming of vibrissae.
Outcomes
Primary Outcome Measures
Nasal airflow/pressure
Objective measures include airflow and pressure as assessed by Rhinomanometry.
Subjective Nasal Obstruction
Subjective measures will be assessed via the modified version of the NOSE outcome instrument-a validated test of subjective nasal obstruction
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01850511
Brief Title
The Effect of Nasal Hair on Nasal Obstruction
Official Title
The Effect of Vibrissae on Subjective and Objective Measures of Nasal Obstruction
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Nasal obstruction is a common complaint prompting presentation to an otolaryngologist. Many studies have been performed quantifying and describing the impact of a number of factors on symptoms of nasal obstruction, including anatomical, neoplastic, infectious, and inflammatory causes. Despite this scrutiny, no attention has been paid to the nasal vibrissae as a potential anatomical contributor to nasal obstruction. The proposed study intends to elucidate that contribution, if any exists.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasal Obstruction
Keywords
Nasal obstruction, Vibrissae, Nasal hair
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vibrissae trimming
Arm Type
Experimental
Arm Description
Patients will serve as their own control, with assessment of primary outcomes pre- and post-trimming of vibrissae.
Intervention Type
Procedure
Intervention Name(s)
Vibrissae trimming
Intervention Description
Patients will have oxymetazoline administered prior to assessment of outcome measures to ensure minimal impact of erectile mucosal tissue on measurement.
Intervention Type
Drug
Intervention Name(s)
Application of oxymetazoline
Other Intervention Name(s)
Afrin
Intervention Description
Afrin will be administered to minimize the impact of erectile mucosal tissue on obstruction.
Primary Outcome Measure Information:
Title
Nasal airflow/pressure
Description
Objective measures include airflow and pressure as assessed by Rhinomanometry.
Time Frame
Participants will undergo assessment over a 30 minute period, no follow-up
Title
Subjective Nasal Obstruction
Description
Subjective measures will be assessed via the modified version of the NOSE outcome instrument-a validated test of subjective nasal obstruction
Time Frame
Participants will undergo assessment over a 30 minute period, no follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Presence of nasal vibrissae
Able to tolerate rhinomanometry
Exclusion Criteria:
Anatomical or other obvious cause of obstruction
Claustrophobia with rhinomanometry mask
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Grant Hamilton, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
21447962
Citation
Ozturk AB, Damadoglu E, Karakaya G, Kalyoncu AF. Does nasal hair (vibrissae) density affect the risk of developing asthma in patients with seasonal rhinitis? Int Arch Allergy Immunol. 2011;156(1):75-80. doi: 10.1159/000321912. Epub 2011 Mar 30.
Results Reference
background
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
The Effect of Nasal Hair on Nasal Obstruction
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