Nasal ObstructionNCT00683254
Analysis of Impact on Nasal Obstruction by Commercially Available Internal Nasal Stents
An observational study of Nasal Obstruction, run by Bethany L. Jones at 1 site in United States.
Trial summary
Commercially-available internal nasal stents placed inside the nostril should produce decreased nasal obstruction detectable subjectively (volunteers will fill out a survey) and objectively (degree of obstruction will be measured with a rhinomanometer which measure resistant of airflow while breathing through nose). Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Nasal Obstruction
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- May 2008to Aug 2008
- Phase
- Observational
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Our subject pool will be comprised of healthy volunteers, at least 18 years of age, who have not had nasal surgery, are not currently using a topical decongestant, topical nasal steroid spray, or over the counter decongestant, and have no history of recurrent epistaxis or a running nosebleed within 2 weeks prior to data collection.
Who may be able to join
- 18 years or older
Who cannot join
- history of nasal surgery, currently using topical nasal steroid spray, over the counter decongestant, history of recurrent epistaxis or history of nosebleed within 2 weeks prior to data collection, currently pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Iowa Department of Otolaryngology
Iowa City, Iowa, 52242
About this study
Commercially-available internal nasal stents placed inside the nostril should produce decreased nasal obstruction detectable subjectively (volunteers will fill out a survey) and objectively (degree of obstruction will be measured with a rhinomanometer which measure resistant of airflow while breathing through nose).
Read the detailed description
Nasal rhinomanometry provides a measure of the airflow through the nose during inspiration and expiration. The effect of static obstructions, such as septal deviation, as well as dynamic obstructions, such as lateral nasal wall collapse, can be measured by the rhinomanometer. The effect of commercially available nasal stents on nasal airflow will be measured. In subjects chosen from the general population, some of whom may not complain of nasal obstruction, the airflow will be measured before and after the placement of removable nasal silastic stents. In addition, these subjects will complete a one question scale in the Likert model to rate the degree of their subjective nasal obstruction; they will complete this both before and after placement of the stents. The results of the scale before and after application of the stents will be correlated with the objective measurements of airflow by rhinomanometry taken before and after stent insertion.Several studies have measured the effect of external nasal splints (such as Breathe-Rite strips) on nasal airflow and nasal airway size (as measured by acoustic rhinometry), but few have studied internal nasal stents. No studies have correlated rhinomanometric evaluation of effect on nasal obstruction by nasal stents with the validated NOSE survey (Nasal Obstruction Symptom Evaluation). In patients with a chief complaint of nasal obstruction and who are noted to have anterior nasal obstruction, nasal stents may provide a satisfactory improvement in nasal airflow without surgical or medicinal intervention. For patients who are determined to be candidates for surgical intervention, the surgical procedure is tailored to their specific anatomic deformities, as determined by the staff facial plastic surgeon. While the patient's complaint of nasal obstruction as well as the surgeon's assessment of the nasal anatomy are important components in the determination of the need for surgical intervention, no studies have utilized the validated NOSE instrument of subjective complaint of nasal obstruction combined with objective measurements of dynamic airflow. Rhinomanometric measurements can be used to further validate the NOSE instrument both preoperatively and postoperatively.
- Conditions
- Nasal Obstruction
- Keywords
- nasal obstruction, nasal stent
- Medical subject headings
- Nasal Obstruction
What is being measured
The primary outcome is the main question the study is designed to answer.
change in resistance to airflow after stents inserted as measured by rhinomanometer
Measured: data collection occurs at one time only, takes less than 5 minutes to record
Secondary outcomes (1)
subjective decrease in nasal obstruction after stents placed recorded by volunteers filling out a survey
Measured: recorded at time of stent placement, one time only
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2008 (estimated)
- Study startMay 2008
- Primary completionAug 2008 (estimated)
- Study completionAug 2008 (estimated)
Why it stopped: Principal Investigator left institution. Project never started.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Nasal ObstructionStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bethany L. Jones
- Sponsor type
- University, hospital or other
- Collaborators
- Sanostec Corp.
- Responsible party
- Sponsor-investigator, Bethany L. Jones, University of Iowa
- Investigators
- Bethany L Jones, MD, Principal investigator, University of Iowa Department of OtolaryngologyGrant Hamilton, MD, Study director, University of Iowa Department of Otolaryngology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00683254
- Sponsor's protocol ID
- Sanostec-200701751
- Status last verified
- May 2017
- First submitted
- 21 May 2008
- Last updated
- 11 May 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Lam DJ, James KT, Weaver EM. Comparison of anatomic, physiological, and subjective measures of the nasal airway. Am J Rhinol. 2006 Sep-Oct;20(5):463-70. doi: 10.2500/ajr.2006.20.2940.
PubMed 17063739Wong LS, Johnson AT. Decrease of resistance to air flow with nasal strips as measured with the airflow perturbation device. Biomed Eng Online. 2004 Oct 22;3(1):38. doi: 10.1186/1475-925X-3-38.
PubMed 15500689Suzina AH, Hamzah M, Samsudin AR. Objective assessment of nasal resistance in patients with nasal disease. J Laryngol Otol. 2003 Aug;117(8):609-13. doi: 10.1258/002221503768199933.
PubMed 12956914Huang TW, Cheng PW. Changes in nasal resistance and quality of life after endoscopic microdebrider-assisted inferior turbinoplasty in patients with perennial allergic rhinitis. Arch Otolaryngol Head Neck Surg. 2006 Sep;132(9):990-3. doi: 10.1001/archotol.132.9.990.
PubMed 16982976
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Impact on Nasal Obstruction by Commercially Available Internal Nasal Stents
- ClinicalTrials.gov ID
- NCT00683254
- Acronym / sponsor ID
- Sanostec-200701751
- Conditions
- Nasal Obstruction
- Keywords
- nasal obstruction, nasal stent
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Principal Investigator left institution. Project never started.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Bethany L. JonesUniversity, hospital or other
- Collaborators
- Sanostec Corp.
- Study start
- May 2008 (actual)
- Primary completion
- Aug 2008 (estimated)
- Study completion
- Aug 2008 (estimated)
- First posted
- 23 May 2008 (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.
Commercially-available internal nasal stents placed inside the nostril should produce decreased nasal obstruction detectable subjectively (volunteers will fill out a survey) and objectively (degree of obstruction will be measured with a rhinomanometer which measure resistant of airflow while breathing through nose).
Detailed description
Nasal rhinomanometry provides a measure of the airflow through the nose during inspiration and expiration. The effect of static obstructions, such as septal deviation, as well as dynamic obstructions, such as lateral nasal wall collapse, can be measured by the rhinomanometer. The effect of commercially available nasal stents on nasal airflow will be measured. In subjects chosen from the general population, some of whom may not complain of nasal obstruction, the airflow will be measured before and after the placement of removable nasal silastic stents. In addition, these subjects will complete a one question scale in the Likert model to rate the degree of their subjective nasal obstruction; they will complete this both before and after placement of the stents. The results of the scale before and after application of the stents will be correlated with the objective measurements of airflow by rhinomanometry taken before and after stent insertion.Several studies have measured the effect of external nasal splints (such as Breathe-Rite strips) on nasal airflow and nasal airway size (as measured by acoustic rhinometry), but few have studied internal nasal stents. No studies have correlated rhinomanometric evaluation of effect on nasal obstruction by nasal stents with the validated NOSE survey (Nasal Obstruction Symptom Evaluation). In patients with a chief complaint of nasal obstruction and who are noted to have anterior nasal obstruction, nasal stents may provide a satisfactory improvement in nasal airflow without surgical or medicinal intervention. For patients who are determined to be candidates for surgical intervention, the surgical procedure is tailored to their specific anatomic deformities, as determined by the staff facial plastic surgeon. While the patient's complaint of nasal obstruction as well as the surgeon's assessment of the nasal anatomy are important components in the determination of the need for surgical intervention, no studies have utilized the validated NOSE instrument of subjective complaint of nasal obstruction combined with objective measurements of dynamic airflow. Rhinomanometric measurements can be used to further validate the NOSE instrument both preoperatively and postoperatively.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Our subject pool will be comprised of healthy volunteers, at least 18 years of age, who have not had nasal surgery, are not currently using a topical decongestant, topical nasal steroid spray, or over the counter decongestant, and have no history of recurrent epistaxis or a running nosebleed within 2 weeks prior to data collection.
Key inclusion criteria (1 listed)
- 18 years or older
Key exclusion criteria (1 listed)
- history of nasal surgery, currently using topical nasal steroid spray, over the counter decongestant, history of recurrent epistaxis or history of nosebleed within 2 weeks prior to data collection, currently pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
change in resistance to airflow after stents inserted as measured by rhinomanometer
Time frame: data collection occurs at one time only, takes less than 5 minutes to record
1 secondary outcome
subjective decrease in nasal obstruction after stents placed recorded by volunteers filling out a survey
Time frame: recorded at time of stent placement, one time only
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2017.
- Background: PubMed 17063739Lam DJ, James KT, Weaver EM. Comparison of anatomic, physiological, and subjective measures of the nasal airway. Am J Rhinol. 2006 Sep-Oct;20(5):463-70. doi: 10.2500/ajr.2006.20.2940.
- Background: PubMed 15500689Wong LS, Johnson AT. Decrease of resistance to air flow with nasal strips as measured with the airflow perturbation device. Biomed Eng Online. 2004 Oct 22;3(1):38. doi: 10.1186/1475-925X-3-38.
- Background: PubMed 12956914Suzina AH, Hamzah M, Samsudin AR. Objective assessment of nasal resistance in patients with nasal disease. J Laryngol Otol. 2003 Aug;117(8):609-13. doi: 10.1258/002221503768199933.
- Background: PubMed 16982976Huang TW, Cheng PW. Changes in nasal resistance and quality of life after endoscopic microdebrider-assisted inferior turbinoplasty in patients with perennial allergic rhinitis. Arch Otolaryngol Head Neck Surg. 2006 Sep;132(9):990-3. doi: 10.1001/archotol.132.9.990.
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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.
Bethany L Jones, MD principal investigator
University of Iowa Department of Otolaryngology
Grant Hamilton, MD study director
University of Iowa Department of Otolaryngology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nasal Obstruction, run by Bethany L. Jones 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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 11 May 2017. 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 was withdrawn before enrolling participants, so there are no results.
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?
change in resistance to airflow after stents inserted as measured by rhinomanometer (time frame: data collection occurs at one time only, takes less than 5 minutes to record). 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 NCT00683254, which also lists 4 linked publications.
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 11 May 2017.