Nasal ObstructionNCT01850511
The Effect of Nasal Hair on Nasal Obstruction
A study testing Vibrissae trimming and Application of oxymetazoline in people with Nasal Obstruction, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nasal Obstruction
- What is being tested?
- Vibrissae trimming and Application of oxymetazoline
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to Oct 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Presence of nasal vibrissae
- Able to tolerate rhinomanometry
Who cannot join
- Anatomical or other obvious cause of obstruction
- Claustrophobia with rhinomanometry mask
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: 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.
- Conditions
- Nasal Obstruction
- Being tested
- Vibrissae trimming, Application of oxymetazoline
- Keywords
- Nasal obstruction, Vibrissae, Nasal hair
- Medical subject headings
- Nasal Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vibrissae trimmingProcedure or surgery
Patients will have oxymetazoline administered prior to assessment of outcome measures to ensure minimal impact of erectile mucosal tissue on measurement.
Application of oxymetazolineDrug
Also called Afrin
Afrin will be administered to minimize the impact of erectile mucosal tissue on obstruction.
| Study group | Role | What they receive |
|---|---|---|
| Vibrissae trimming | Experimental | Patients will serve as their own control, with assessment of primary outcomes pre- and post-trimming of vibrissae. Receives: Procedure: Vibrissae trimming; Drug: Application of oxymetazoline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nasal airflow/pressure
Objective measures include airflow and pressure as assessed by Rhinomanometry.
Measured: 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
Measured: Participants will undergo assessment over a 30 minute period, no follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2013 (estimated)
- Study startMay 2013
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nasal ObstructionStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Grant S. Hamilton, III, Mayo Clinic
- Investigators
- Grant Hamilton, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01850511
- Sponsor's protocol ID
- 12-001362
- Status last verified
- Apr 2019
- First submitted
- 3 May 2013
- Last updated
- 22 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 21447962
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Vibrissae on Subjective and Objective Measures of Nasal Obstruction
- ClinicalTrials.gov ID
- NCT01850511
- Acronym / sponsor ID
- 12-001362
- Conditions
- Nasal Obstruction
- Keywords
- Nasal obstruction, Vibrissae, Nasal hair
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 9 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vibrissae trimming | Experimental | Procedure: Vibrissae trimming, Drug: Application of oxymetazolinePatients will serve as their own control, with assessment of primary outcomes pre- and post-trimming of vibrissae. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Presence of nasal vibrissae
- Able to tolerate rhinomanometry
Key exclusion criteria (2 listed)
- Anatomical or other obvious cause of obstruction
- Claustrophobia with rhinomanometry mask
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vibrissae trimmingPatients will have oxymetazoline administered prior to assessment of outcome measures to ensure minimal impact of erectile mucosal tissue on measurement. | Procedure or surgery | Vibrissae trimming |
| Application of oxymetazolineAlso: AfrinAfrin will be administered to minimize the impact of erectile mucosal tissue on obstruction. | Drug | Vibrissae trimming |
Primary outcome
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.
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2019.
- Background: PubMed 21447962Ozturk 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.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
Related trials for Nasal Obstruction
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Active, not recruitingObservational study
A Prospective Study Comparing VivAer to Alternative Surgical Procedures to Treat Nasal Airway Obstruction in Patients With Nasal Valve Dysfunction.
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Nasal Obstruction Due to Inferior Turbinate Hypertrophy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Grant Hamilton, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vibrissae trimming and Application of oxymetazoline in people with Nasal Obstruction, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nasal airflow/pressure (time frame: Participants will undergo assessment over a 30 minute period, no follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01850511, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2019.