- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01850511
The Effect of Nasal Hair on Nasal Obstruction
April 19, 2019 updated by: Grant S. Hamilton, III, Mayo Clinic
The Effect of Vibrissae on Subjective and Objective Measures of Nasal Obstruction
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
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
-
-
Minnesota
-
Rochester, Minnesota, United States, 55905
- Mayo Clinic in Rochester
-
-
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 and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Presence of nasal vibrissae
- Able to tolerate rhinomanometry
Exclusion Criteria:
- Anatomical or other obvious cause of obstruction
- Claustrophobia with rhinomanometry mask
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
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Vibrissae trimming
Patients will serve as their own control, with assessment of primary outcomes pre- and post-trimming of vibrissae.
|
Patients will have oxymetazoline administered prior to assessment of outcome measures to ensure minimal impact of erectile mucosal tissue on measurement.
Afrin will be administered to minimize the impact of erectile mucosal tissue on obstruction.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Nasal airflow/pressure
Time Frame: Participants will undergo assessment over a 30 minute period, no follow-up
|
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
Time Frame: Participants will undergo assessment over a 30 minute period, no follow-up
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Grant Hamilton, MD, Mayo Clinic
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.
Helpful Links
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
May 1, 2013
Primary Completion (Actual)
October 1, 2013
Study Completion (Actual)
October 1, 2013
Study Registration Dates
First Submitted
May 3, 2013
First Submitted That Met QC Criteria
May 7, 2013
First Posted (Estimate)
May 9, 2013
Study Record Updates
Last Update Posted (Actual)
April 22, 2019
Last Update Submitted That Met QC Criteria
April 19, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Respiration Disorders
- Otorhinolaryngologic Diseases
- Nose Diseases
- Respiratory Insufficiency
- Airway Obstruction
- Nasal Obstruction
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Protective Agents
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Cardiotonic Agents
- Respiratory System Agents
- Sympathomimetics
- Vasoconstrictor Agents
- Mydriatics
- Nasal Decongestants
- Adrenergic alpha-1 Receptor Agonists
- Phenylephrine
- Oxymetazoline
Other Study ID Numbers
- 12-001362
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
Clinical Trials on Nasal Obstruction
-
BayerCompletedNasal Congestion, Nasal ObstructionCanada
-
Aerin MedicalNot yet recruitingNasal Airway Obstruction
-
Saglik Bilimleri UniversitesiCompletedNasal Obstruction Septal Deviation Compensatory Inferior Turbinate HypertrophyTurkey (Türkiye)
-
Cumhuriyet University HospitalRecruitingNasal Obstruction | Rhinoplasty | Nasal DeformityTurkey (Türkiye)
-
Spirair, IncActive, not recruitingNasal Airway Obstruction | Nasal Septal DeviationUnited States
-
Aerin MedicalOhio State UniversityCompletedNasal ObstructionUnited States
-
Aerin MedicalActive, not recruiting
-
Aerin MedicalCompletedNasal Airway ObstructionUnited States
-
Aerin MedicalCompletedNasal ObstructionUnited States
-
Medtronic Surgical TechnologiesCompletedNasal Airway ObstructionUnited States, Canada
Clinical Trials on Vibrissae trimming
-
George Emil Palade University of Medicine, Pharmacy...Orto Performance Orthodontic Laboratory, Cluj-Napoca, Romania (aligner fabrication)Active, not recruitingPeriodontal Diseases | Gingivitis | Dental PlaqueRomania
-
Siriraj HospitalUnknownAndrogenetic AlopeciaThailand
-
Ataturk UniversityCompletedCesarean Section, Repeated | Cesarean, Uterine Scar Thickness | Cesarean, Residual Myometrial ThicknessTurkey
-
Cairo UniversityRecruitingGingival HyperpigmentationEgypt