An observational study in Nasal Airway Obstruction, sponsored by Aerin Medical. Completed at 1 site in United States. Open to participants aged 22 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-12-26.
Sponsored by Aerin Medical · Observational
The purpose of this study is to assess and compare the clinical outcomes associated with common surgical interventions for the treatment of nasal airway obstruction (NAO).
This is a multicenter, ambispective registry study. The study will include assessment of prospective, long term outcomes by remote administration of patient reported outcome questionnaires. Participants identified in Part 1 of the study with outcomes available for at least 12 months following their surgical procedure for nasal airway obstruction will be identified by the treating physician and invited to participate in the long-term follow-up study. Participants agreeing to participate will be asked to complete a series of questions about their health experience following their surgery and will be asked to complete select health outcome questionnaires using a secure electronic survey platform.
Patients with nasal airway obstruction that had either a functional rhinoplasty or septoturbinoplasty within the time frame of January 01, 2013 to December 31, 2023 or a TCRF procedure between the dates of November 19, 2015 to December 31, 2023.
Exclusion Criteria:
Patients received a non-study/Standard of Care Functional Rhinoplasty within the past 5 years
Patients received a non-study/Standard of Care Septoplasty within the past 5 years
Patients received a Vivaer procedure (radiofrequency) within the past 5 years
Patients received a Rhinaer procedure (radiofrequency) within the past 5 years
Nasal Obstruction Symptom Scale (NOSE) Score
The NOSE survey is a disease-specific questionnaire designed to measure nasal obstruction. It is commonly used in otolaryngology practice to provide an objective measure of nasal obstruction. Patients rate on a 0-4 scale questions regarding congestion, ability to get air in nose during exercise, and others. Scores result in symptom severity classes of mild, moderate, severe or extreme NAO.
Time frame: Jan 2013 - Dec 2025
22-Item Sinonasal Nasal Outcome Test (SNOT-22)
The The Sino-Nasal Outcome Test (SNOT-22) Questionnaire is a validated patient-reported outcome measure established to delineate the presence and severity of sinonasal disorders. It is a widely used questionnaire for assessing the impact of chronic rhinosinusitis on a patient's quality of life. Minimum possible score: 0; Maximum possible score: 110. Higher scores indicate: A worse outcome, meaning more severe symptoms and a greater negative impact on quality of life.
Time frame: Jan 2013 - Dec 2025
Standard Cosmesis and Health Outcomes Survey (SCHNOS)
The SCHNOS survey is a validated 10-item survey with two-domains (nasal obstruction and nasal cosmesis) patient-reported outcomes survey designed to evaluate both functional and cosmetic components of rhinoplasty. Minimum possible score: 0, Maximum possible score: 40. Higher scores indicate: A better outcome, meaning improved nasal function and cosmesis.
Time frame: Jan 2013 - Dec 2025
Short Form-12 (SF-12 version 1)
SF-12 is a 12 question self-reported outcome measure assessing the impact of health on an individual's everyday life. It includes questions in 8 domains: limitations in physical activities due to health problems, limitations in social activities because of physical or emotional problems, limitations on usual role activities because of physical or emotional health problems, bodily pain, general mental health, vitality, and general health perceptions. A score above 50 indicates better than average health-related quality of life and scores less than 50 suggest below-average health. Minimum possible score: 0, Maximum possible score: 100. Higher scores indicate: A better outcome, meaning improved health-related quality of life
Time frame: Jan 2013 - Dec 2025
Mini-Rhinoconjunctivitis Quality of Life Score (Mini-RQLQ)
The mini-RQLQ is a self-administered questionnaire that measures functional impairments that are most troublesome to adult patients because of their rhinoconjunctivitis. This instrument has 14 questions in 5 domains: activity limitation, practical problems, nose symptoms, eye symptoms and non-nose/eye symptoms). Minimum possible score: 0, Maximum possible score: 42. Higher scores indicate: A worse outcome, meaning more severe symptoms and a greater negative impact on quality of life.
Time frame: Jan 2013- Dec 2025
Epworth Sleepiness Scale (ESS)
The ESS is a validated widely used self-administered screening questionnaire that evaluates excessive daytime sleepiness.
Time frame: Jan 2013 - Dec 2025
Change in Medication Dose
Change in the dose from prior to procedure to post procedure of medication used for treating Nasal Airway Obstruction Symptoms
Time frame: Jan 2013 - Dec 2025
Change in Medication Frequency
Change in the frequency of use (prior to procedure to post procedure) of medication used for treating Nasal Airway Obstruction Symptoms
Time frame: Jan 2013 - Dec 2025
Change in use of Nasal Airway Obstruction Devices
Change in use of devices used for Nasal Airway Obstruction from prior to procedure to Post Procedure
Time frame: Jan 2013 - Dec 2025
Plan to share: Undecided
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This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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