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

NCT00683254 | Withdrawn

• 1 other identifier: Sanostec-200701751
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Nasal Obstruction

Keywords

nasal obstruction; nasal stent

Outcome Measures

Primary Outcomes (1)

• change in resistance to airflow after stents inserted as measured by rhinomanometer

  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

  recorded at time of stent placement, one time only

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• years or older

You may not qualify if:

• 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

Sponsors & Collaborators

• Bethany L. Jones: lead
• Sanostec Corp.: collaborator

Study Sites (1)

University of Iowa Department of Otolaryngology

Iowa City, Iowa, 52242, United States

Location

Related Publications (4)

• 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.

  PMID: 17063739 BACKGROUND

• Wong 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.

  PMID: 15500689 BACKGROUND

• Suzina 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.

  PMID: 12956914 BACKGROUND

• Huang 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.

  PMID: 16982976 BACKGROUND

MeSH Terms

Conditions

Nasal Obstruction

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Airway Obstruction; Respiratory Insufficiency; Respiration Disorders; Otorhinolaryngologic Diseases

Study Officials

• Bethany L Jones, MD

  University of Iowa Department of Otolaryngology

  PRINCIPAL INVESTIGATOR

• Grant Hamilton, MD

  University of Iowa Department of Otolaryngology

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 21, 2008
• First Posted: May 23, 2008
• Study Start: May 1, 2008
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: May 11, 2017

Record last verified: 2017-05

Locations

US (1)