NCT01850511

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

May 3, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 9, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

April 22, 2019

Status Verified

April 1, 2019

Enrollment Period

5 months

First QC Date

May 3, 2013

Last Update Submit

April 19, 2019

Conditions

Keywords

Nasal obstructionVibrissaeNasal hair

Outcome Measures

Primary Outcomes (2)

  • Nasal airflow/pressure

    Objective measures include airflow and pressure as assessed by Rhinomanometry.

    Participants will undergo assessment over a 30 minute period, no follow-up

  • Subjective Nasal Obstruction

    Subjective measures will be assessed via the modified version of the NOSE outcome instrument-a validated test of subjective nasal obstruction

    Participants will undergo assessment over a 30 minute period, no follow-up

Study Arms (1)

Vibrissae trimming

EXPERIMENTAL

Patients will serve as their own control, with assessment of primary outcomes pre- and post-trimming of vibrissae.

Procedure: Vibrissae trimmingDrug: Application of oxymetazoline

Interventions

Patients will have oxymetazoline administered prior to assessment of outcome measures to ensure minimal impact of erectile mucosal tissue on measurement.

Vibrissae trimming

Afrin will be administered to minimize the impact of erectile mucosal tissue on obstruction.

Also known as: Afrin
Vibrissae trimming

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Presence of nasal vibrissae
  • Able to tolerate rhinomanometry

You may not qualify if:

  • Anatomical or other obvious cause of obstruction
  • Claustrophobia with rhinomanometry mask

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

  • 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.

    PMID: 21447962BACKGROUND

Related Links

MeSH Terms

Conditions

Nasal Obstruction

Interventions

Oxymetazoline

Condition Hierarchy (Ancestors)

Nose DiseasesRespiratory Tract DiseasesAirway ObstructionRespiratory InsufficiencyRespiration DisordersOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Grant Hamilton, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 3, 2013

First Posted

May 9, 2013

Study Start

May 1, 2013

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

April 22, 2019

Record last verified: 2019-04

Locations