Analysis of Impact on Nasal Obstruction by Commercially Available Internal Nasal Stents

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by University of Iowa.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Sanostec Corp.
Information provided by:
University of Iowa
ClinicalTrials.gov Identifier:
NCT00683254
First received: May 21, 2008
Last updated: May 22, 2008
Last verified: May 2008
  Purpose

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).


Condition
Nasal Obstruction

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Analysis of Impact on Nasal Obstruction by Commercially Available Internal Nasal Stents

Further study details as provided by University of Iowa:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 35
Study Start Date: May 2008
Estimated Study Completion Date: August 2008
Estimated Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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.

Criteria

Inclusion Criteria:

  • 18 years or older

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00683254

Contacts
Contact: Bethany L Jones, MD 319-356-3600 bethany-jones@uiowa.edu
Contact: Marcy Simpson 319-356-3600 marcy-simpson@uiowa.edu

Locations
United States, Iowa
University of Iowa Department of Otolaryngology Not yet recruiting
Iowa City, Iowa, United States, 52242
Principal Investigator: Bethany L Jones, MD         
Sponsors and Collaborators
University of Iowa
Sanostec Corp.
Investigators
Principal Investigator: Bethany L Jones, MD University of Iowa Department of Otolaryngology
Study Director: Grant Hamilton, MD University of Iowa Department of Otolaryngology
  More Information

Publications:
Responsible Party: Bethany Jones, MD, principal investigator, University of Iowa Department of Otolaryngology
ClinicalTrials.gov Identifier: NCT00683254     History of Changes
Other Study ID Numbers: Sanostec-200701751
Study First Received: May 21, 2008
Last Updated: May 22, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by University of Iowa:
nasal obstruction
nasal stent

Additional relevant MeSH terms:
Nasal Obstruction
Nose Diseases
Respiratory Tract Diseases
Airway Obstruction
Respiratory Insufficiency
Respiration Disorders
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on July 20, 2014